[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-diffuse-large-b-cell-lymphoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,53,75,106,126,154,180,205,234,255,290,316,345,365,392,412,438,463,486,512,542],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100585680","phase-2-epcoritamab-plus-standard-of-care-platinum-based-chemotherapy-and-autologous-hematopoietic-cell-transplant-for-the-treatment-of-relapsed-or-refractory-large-b-cell-lymphoma-100585680",false,"NCT06905509","Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma","A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation\u002F Maintenance in Relapsed\u002F Refractory Large B-Cell Lymphoma (R\u002FR LBCL)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed R\u002FR LBCL\n\n  * Can include diffuse large B-cell lymphoma (DLBCL) (not otherwise specified \\[NOS\\] or with concurrent MYC and BCL2 rearrangements), high-grade B-cell lymphoma (HGBCL) (NOS or with MYC and BCL2 or BCL6 rearrangements) and transformed follicular lymphoma (FL) and nodal marginal zone lymphoma (MZL)\n  * Histological confirmed CD20+ relapsed\u002F refractory large cell lymphoma\n* Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET\u002FCT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET\u002FCT per the Lugano criteria\n* Have received 1 or more prior lines of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy\n* Candidate for platinum-containing chemotherapy (RICE, RDHAP\u002FX, or R-Gem\u002FOx) pre-autologous hematopoietic cell transplantation (autoHCT) followed by autoHCT as per institutional guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Measurable disease via diagnostic quality CT or PET\u002FCT with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\> 1 cm (per the Lugano criteria 2014)\n* Aged ≥ 18 at the time of consent\n* Creatinine clearance (CrCl) ≥ 45 mL\u002Fmin (Cockcroft-Gault)\n* Serum alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN)\n* Serum aspartate aminotransferase (AST) ≤ 3 x ULN\n* Bilirubin ≤ 1.5 x ULN unless due to Gilbert's syndrome or controlled autoimmune hemolytic anemia (not requiring immunosuppressive other than ≤ 20 mg of prednisolone daily)\n\n  * Note: Patients with Gilbert's syndrome may be included if total bilirubin is ≤ 3 x ULN and direct bilirubin is ≤ 1.5 x ULN\n* Hemoglobin ≥ 8.0 g\u002FdL\n\n  * Note: Blood transfusion may be administered during Screening to meet this requirement only if anemia is due to marrow involvement of non-Hodgkin lymphoma (NHL)\n* Absolute neutrophil count ≥ 1000\u002FuL\n\n  * Note: Growth factor support is allowed to meet this requirement at Screening only if directly attributable to NHL infiltration of the bone marrow, proven by bone marrow biopsy\n* Platelet count ≥ 75,000\u002FuL or ≥ 50,000\u002FuL if bone marrow (BM) involvement or splenomegaly\n\n  * Note: Transfusion may be administered during screening to meet this requirement\n* prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* Note: If any of the above-mentioned cytopenias are present, there should be no evidence of myelodysplastic syndrome (MDS) or hypoplastic bone marrow\n* HIV-infected patients on effective anti-retroviral therapy with stable viral load and CD4 count for 1 year prior to enrollment are eligible for this trial. Testing for HIV viral load and antibody at screening is mandatory\n* Patients with a history of chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Patients with evidence of prior HBV but who are polymerase chain reaction (PCR)-negative are permitted in the trial but should receive prophylactic antiviral therapy. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C ribonucleic acid (RNA) levels are undetectable. Testing for HBV and HCV is mandatory at screening\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after the last dose of epcoritamab\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Any adverse event (AE) related to the previous large cell lymphoma therapy which has not recovered to grade ≤ 1 (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v.\\] 5.0) or baseline by cycle 1 day 1 (C1D1), except alopecia and non-clinically significant laboratory abnormalities\n* Uncontrolled intercurrent illness (including infection)\n* Known active central nervous system or meningeal (including leptomeningeal) involvement. Patients diagnosed with central nervous system (CNS) disease who achieved and maintained CNS complete response (CR) at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry (within 90 days of enrollment) to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings)\n* Receiving any other investigational treatments\n* Previous treatment with any bispecific T-cell engager with or without chemotherapy\n* Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab\n* Concurrent use of other anti-cancer agents or treatments except for certain therapeutics (e.g., prostate, breast hormonal-based therapy) per the treating physician's discretion\n\n  * Standard agents within 2 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab (excluding anti-CD20 monoclonal antibodies \\[mAbs\\], which can be administered until first full dose of epcoritamab); or\n  * CAR-T cell therapy within 30 days prior to the first dose of epcoritamab\n  * Palliative radiation is permitted only if on non-target lesions\n* Motor and sensory neuropathy grade ≥ 2 (CTCAE v.5.0)\n* Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumors curatively treated with no evidence of disease for at least 3 years\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrollment or significant infections within 2 weeks prior to the first dose of epcoritamab\n* Confirmed history or current autoimmune disease or other diseases requiring permanent immunosuppressive therapy. Low-dose (10 mg\u002Fday) prednisolone (or equivalent) for rheumatoid arthritis or similar conditions is allowed\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)\n* Participant received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation\n* Autoimmune disease or other diseases that require continuous immunosuppressive therapy (except for prednisone doses of less than or equal to 10 mg, which is allowed)\n* Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia (requiring \\> 20 mg of prednisolone daily) or other concurrent uncontrolled medical conditions\n* Clinically significant cardiac disease including but not limited to:\n\n  * Unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function, e.g., unstable angina, congestive heart failure grade III or IV as classified by the New York Heart Association, uncontrolled clinically significant cardiac arrhythmia (CTCAE v 5.0 grade 2 or higher), or clinically significant electrocardiogram (ECG) abnormalities. Controlled New York Heart Association (NYHA) grade 1 or 2 are eligible\n  * Myocardial infarction, intracranial bleed, or stroke within the past 6 months\n  * Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\> 480 msec. NOTE: This criterion does not apply to participants with a left bundle branch block\n  * In case of any history of cardiovascular disease, a cardiology consult is required within 60 days prior to enrollment\n  * Age ≥ 75 and 2 or more active grade ≥ 2 cardiovascular conditions\n* Prior treatment with live, attenuated vaccines within 28 days prior to initiation of epcoritamab. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Food and Drug Administration (FDA)-approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations allowed\n* Immune effector cell encephalopathy (ICE) score of less than 10 at study entry\n* Suspected allergies, hypersensitivity, or intolerance to epcoritamab or another anti-CD20 mAb or its excipients\n* Active HBV (DNA PCR-positive). Patients with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy\n* Active hepatitis C (RNA PCR-positive infection). Patients who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable\n* Known history of seropositivity for HIV infection\n* Active cytomegalovirus (CMV) infection (PCR positive)\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab\n* Plans to donate sperm or conceive a child through intercourse while enrolled in this trial or within 12 months after the last dose of epcoritamab\n* Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrollment or within the previous 2 weeks prior to the first dose of epcoritamab\n* Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Note: SARS-CoV-2 diagnostic tests should be applied following local requirements\u002Frecommendations. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen per criteria\n* Suspected active or inadequately treated latent tuberculosis","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide \\[RICE\\], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP\u002FX\\] or gemcitabine and oxaliplatin \\[Gem\u002FOx\\]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP\u002FX and Gem\u002FOx, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent Nodal Marginal Zone Lymphoma","Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory Nodal Marginal Zone Lymphoma","Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","RECRUITING","2026-06-25",{"date":43,"type":44},"2026-06-30","ACTUAL",{"date":46,"type":44},"2025-07-31",{"date":48,"type":20},"2030-08-01",{"name":50,"class":51},"University of California, Davis","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":52},"100644923","phase-1-lymphodepletion-with-low-dose-total-body-irradiation-before-standard-of-care-tisagenlecleucel-for-the-treatment-of-relapsed-and-recurrent-large-b-cell-lymphoma-100644923","NCT07676877","Lymphodepletion With Low Dose Total Body Irradiation Before Standard of Care Tisagenlecleucel for the Treatment of Relapsed and Recurrent Large B-cell Lymphoma","A Phase I Trial of Lymphodepletion Intensification With Low Dose Total Body Irradiation With Dose Expansion for Standard-of-Care Tisagenlecleucel in Patients With Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Eligible for standard of care anti-CD19 CAR-T treatment with Tisa-cel\n* Age ≥ 18 years\n* Biopsy-confirmed relapsed or refractory large B-cell lymphoma after 2 lines of prior therapy\n* Qualitative CD19 expression by either immunohistochemistry (IHC) or flow cytometry\n* Measurable disease prior to lymphodepletion as determined by Lugano criteria\n* Non-RT bridging therapy allowed, but requires re-staging prior to lymphodepletion (LD) to confirm measurable disease\n* Adequate performance status Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Platelets above 75K\n* Hemoglobin above 8.0 g\u002FdL without transfusion within 1 week\n* Absolute neutrophil count (ANC) above 1,000 without granulocyte colony-stimulating factor (G-CSF) within 1 week\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Glomerular filtration rate (GFR) \\> 60 ml\u002Fmin calculated by the Cockcroft - Gault formula\n* Oxygen saturation (SpO2) \\> 92% without supplemental oxygen\n* Ejection fraction more than 45%\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after Tisa-cel and until CAR T-cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptive s that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after Tisa-cel infusion and until CAR T-cells are no longer present by qPCR on two consecutive tests. Men must refrain from donating sperm during this same period\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after Tisa-cel infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n* For patients with prior irradiation: the study radiation oncologist co-investigator will review the patient's prior history of radiation to confirm that the investigational low dose total body irradiation is feasible and safe to respect the maximum cumulative organ radiation exposure\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease at screening or prior to lymphodepletion\n* Prior therapy with autologous or allogenic CAR-T or CAR-natural killer (NK) cell therapy\n* Prior anti-CD19 therapies (such as, but not limited to tafasitamab or loncastuximab)\n* Prior allogeneic stem cell transplant\n* Bridging therapy with radiation not allowed\n* Any contra-indications to receive low-dose TBI, standard of care lymphodepleting chemotherapy or Tisa-cel per treating physician\n* A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and start of lymphodepletion\n* Uncontrolled major medical problem as infections\n* Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial (e.g. low Gleason score prostate cancer)\n* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n* Active hepatitis B or C as indicated by serology (for details please refer to Novartis Leukapheresis Reference Manual version \\[v\\] 4)\n* Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medication within 6 months\n* Live vaccines given in 28 days prior to lymphodepleting chemotherapy\n* Active substance use disorders",{"count":61,"type":20},18,[63],"PHASE1","This phase I trial tests the safety, side effects, and best dose of total body irradiation (TBI) in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel (Tisa-cel) and how well the combination works in patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). TBI is a common treatment that sends radiation (for example, through x-rays) to the entire body. Lymphodepleting chemotherapy, such as cyclophosphamide and fludarabine, along with TBI helps kill cancer cells in the body and helps prepare the body for the Tisa-cel infusion. Tisagenlecleucel is made using a patient's T cells (a type of immune system cell). A gene for a special receptor called chimeric antigen receptor (CAR) is added to the T cells in the laboratory. These changed T cells called CAR T cells are grown in large numbers in the laboratory and given to the patient by infusion. Tisa-cel binds to a protein called CD19, which is found on some leukemia and lymphoma cells. This helps the body's immune system kill cancer cells. Tisa-cel is a type of CAR T-cell therapy. Giving low dose TBI in combination with standard of care lymphodepletion therapy and Tisa-cel may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory (R\u002FR) LBCL.",[26,33],"NOT_YET_RECRUITING","2026-06-23",{"date":43,"type":44},{"date":70,"type":20},"2026-09-01",{"date":72,"type":20},"2027-12-31",{"name":74,"class":51},"Nathan Denlinger",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100566025","phase-2-testing-the-effectiveness-of-a-combination-targeted-therapy-vipor-for-patients-with-relapsed-andor-refractory-aggressive-b-cell-lymphoma-100566025","NCT06649812","Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and\u002For Refractory Aggressive B-cell Lymphoma","A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:\n\n  * Cohort 1: CD10-negative DLBCL, which includes:\n\n    * CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-\u002FBCL6- or CD10-\u002FBCL6+\u002FMUM1+ DLBCL)\n    * CD10-negative GCB DLBCL, NOS (i.e., CD10-\u002FBCL6+\u002FMUM1- DLBCL)\n    * CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)\n    * CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)\n    * CD10-negative T-cell\u002Fhistiocyte-rich large B-cell lymphoma (THRLBCL) OR\n  * Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)\n\n    * NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration\n* Patient must have relapsed and\u002For refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen\n* Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL)\n* Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU\u002FmL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment.\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy\n* Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide\n* Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment\n* Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration)\n* Hemoglobin ≥ 8 g\u002FdL (obtained ≤ 7 days prior to registration)\n* Platelets ≥ 75,000\u002FmcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration)\n* Creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL)\n* Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration.\n\n  * NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution\n* Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol\n* Patient must not have evidence of an active infection at the time of registration\n* Patient must not have the following current or prior anti-cancer treatment:\n\n  * Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration\n\n    * NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted\n  * More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates\n\n    * NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy\u002Fchimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy\n  * Radio- or toxin-immunoconjugates within 10 weeks prior to registration\n  * Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug \\[IMiD\\])\n  * Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration\n  * Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration\n\n    * NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure\n    * NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis\n\n  * NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2",{"count":83,"type":20},120,[23],"This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and\u002For that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and\u002For refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.",[87,26,88,27,89,90,30,91,33,92,34,93,94,37,95],"High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Recurrent T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Refractory T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","2026-06-20",{"date":67,"type":44},{"date":99,"type":44},"2025-10-07",{"date":101,"type":20},"2027-09-01",{"name":103,"class":104},"National Cancer Institute (NCI)","NIH",84,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":52},"100581734","phase-2-odronextamab-for-the-treatment-of-relapsed-and-refractory-diffuse-large-b-cell-lymphoma-before-and-after-chimeric-antigen-receptor-t-cell-therapy-100581734","NCT06854159","Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy","A Phase 2 Study of Odronextamab in Relapsed\u002F Refractory (R\u002FR) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy","Inclusion Criteria:\n\n* Aged ≥ 18 at the time of consent\n* Patients must have histologically or cytologically confirmed relapsed\u002F refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL); transformed follicular lymphoma patients are eligible\n* Patients must have failed at least 2 prior therapies\n* Life expectancy ≥ 3 months\n* Candidate for any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T cell therapy as per institutional guidelines\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Leukocytes ≥ 2,500\u002FµL\n* Absolute neutrophil count ≥ 1,000\u002FµL or \\> 500\u002FµL for patients with bone marrow involvement\n\n  * A participant may not have received granulocyte colony stimulating factor within 2 days prior to first dose of odronextamab in order to meet the absolute neutrophil count (ANC) eligibility criterion\n* Platelets ≥ 50,000\u002FµL or ≥ 25,000\u002FµL for patients with bone marrow involvement\n\n  * A patient may not have received platelet transfusion therapy within 2 days prior to first dose of odronextamab in order to meet the platelet eligibility criterion\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n\n  * NOTE: patients with known Gilbert disease who have serum bilirubin level ≤ 3 x institutional ULN may be enrolled. Patients with known Gilbert syndrome will be excluded if the total bilirubin value is \\> 4 x ULN\n  * Irrespective of the presence of lymphoma infiltration of the liver, a participant with an aspartate aminotransferase (AST) \\> 3 x ULN and\u002For alanine aminotransferase (ALT) \\> 3 x ULN concurrent with a total bilirubin \\> 1.5 x ULN will be excluded\n* AST(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002FALT(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (AST and\u002For ALT ≤ 5 x ULN for patients with liver involvement)\n\n  * Irrespective of the presence of lymphoma infiltration of the liver, a participant with an AST \\> 3 x ULN and\u002For ALT \\> 3 x ULN concurrent with a total bilirubin \\> 1.5 x ULN will be excluded\n* Creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault\n* Hemoglobin ≥ 8 g\u002FdL or ≥ 7 g\u002FdL for patients with bone marrow involvement\n\n  * NOTE: Growth factor or transfusion support is allowed as per treating physician's discretion\n* Alkaline phosphatase 2.5 x ULN (≤ 5 x ULN for patients with documented liver involvement or bone metastases)\n* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n\n  * NOTE: This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose\n* Cardiac ejection fraction \\> 50% by echocardiogram or multigated acquisition (MUGA) scan\n* Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance by Cockcroft Gault formula ≥ 50 mL\u002Fmin\n* For participants infected with HIV:\n\n  * No history of AIDS-defining conditions other than lymphoma or history of CD4+ T-cells below 200\u002Fmm\\^3 prior to beginning combination antiretroviral therapy (ART)\n  * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n  * At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to ≥ 250\u002Fmm\\^3\n  * At the time of study entry, the HIV viral load must be undetectable by standard laboratory assay\n  * During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV+ status\n  * No history of non-adherence to ART and willing to adhere to ART while on study\n  * Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed\n* People with hepatitis B or C on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible\n* People of child-bearing potential and reproductive partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months (180 days) after the last dose of study agent. Egg and sperm donation is prohibited during the study and for 6 months after the last dose of study agent\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe\u002Fthey were to participate in the study or confounds the ability to interpret data from the study as determined by the study principal investigator (PI) or enrolling physician\n* Known involvement by primary central nervous system (CNS) lymphoma or known uncontrolled involvement by non-primary CNS non-Hodgkin lymphoma (NHL) at the time of study entry\n* Known history (within last 12 months) of or current relevant CNS pathology, such as:\n\n  * Epilepsy, seizure, paresis, aphasia, apoplexy, severe brain injury, cerebellar disease, organic brain syndrome, psychosis, cerebrovascular stroke or\n  * Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral magnetic resonance imaging (MRI)\n* Another active malignancy (aside from B-cell NHL) in the past 5 years, with the following exceptions: non-melanoma skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent as per treating investigator\n* Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic, or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and\u002For has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy\n* Active COVID-19 infection\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n\n  * Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells\u002FµL either spontaneously or on a stable antiviral regimen) are permitted.\n  * Participants who are hepatitis B surface antigen positive or who are hepatitis B core antibody positive should undergo evaluation by a specialist and be considered to have controlled infection (serum hepatitis B virus deoxyribonucleic acid \\[DNA\\] polymerase chain reaction \\[PCR\\] that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) before they are permitted onto study\n  * Participants who are HCV antibody positive who have controlled infection (undetectable HCV ribonucleic acid \\[RNA\\] by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted\n* Cytomegalovirus (CMV) infection as noted by detectable levels on peripheral blood polymerase chain reaction (PCR) assay. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility\n* Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone\u002Fprednisolone or anti-inflammatory equivalent within 72 hours of start of assigned treatment\n* Recent major surgery (within 4 weeks prior to the start of study treatment)\n* Standard radiotherapy within 14 days of first administration of study treatment\n* Prior organ transplantation\n* Administration of live vaccination within 28 days of study first dose\n* Use of any other experimental drug or therapy within 28 days (or 5 half-lives of the drug, whichever is shorter) of initiating study treatment\n* Concurrent use of other anti-cancer treatments except for certain therapeutics (e.g., maintenance hormonal-based therapy) per the treating physician's discretion\n* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment)\n* Pregnancy or lactation\n* Known allergic reactions or hypersensitivity to allopurinol, rasburicase, or compounds of similar chemical or biological components",{"count":114,"type":20},34,[23],"This phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR-T cell therapy is the SOC treatment most patients receive when other treatments have failed. CAR-T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3. Proteins are part of each cell in the body, which work together like little machines for the cell to function. CD20 is a protein that is found on the surface of both normal B-cells and B-cells that make up certain cancers, like DLBCL. CD3 is a protein that is found on the surface of T cells. T-cells and normal B-cells are types of white blood cells in the body and are a part of the immune system that fights infections. Odronextamab is designed to help T-cells find and kill the B-cells including the cancer cells in DLBCL. Giving odronextamab before and after CAR T-cell therapy may improve response in patients with relapsed or refractory DLBCL.",[26,32,33,39],"2026-06-12",{"date":120,"type":44},"2026-06-16",{"date":122,"type":44},"2025-08-07",{"date":124,"type":20},"2029-01",{"name":50,"class":51},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100557279","phase-1-epcoritamab-plus-ibrutinib-for-the-treatment-of-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-100557279","NCT06536049","Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma","Phase Ib\u002FII Trial of Epcoritamab Plus Ibrutinib in Patients With Relapsed\u002FRefractory Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and\u002For immunohistochemistry is based on any representative pathology report)\n\n  * Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell\u002Fhistiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS\n  * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS\n  * Primary mediastinal B-cell lymphoma (PMBCL)\n  * Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization \\[WHO\\] classification of lymphoid neoplasms)\n  * Patients with previously diagnosed indolent lymphoma (follicular lymphoma or marginal zone lymphoma but not lymphoplasmacytic lymphoma or small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia) who have transformed to any of the above lymphoma subtypes are eligible\n* Patients must have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody:\n\n  * ≥ 2 prior systemic lymphoma treatments OR\n  * ≥ 1 prior systemic lymphoma treatment in patients with high-risk disease defined as primary refractory or relapsed within 12 months of completing anthracycline-based frontline treatment who are ineligible for chimeric antigen receptor (CAR) T cells per the treating physician. The reason for CAR T-cell treatment ineligibility should be documented\n  * Prior treatment with a BTK inhibitor is allowed if stopped due to lymphoma progression or treatment completion but not intolerance\n  * Prior treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days prior to enrollment\n  * Prior treatment with CAR T cells is allowed if ≥ 30 days prior to enrollment\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib or epcoritamab in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Measurable disease (defined as \\> 1.5 cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FmcL\n* Platelet count ≥ 75,000\u002FmcL. Platelet count ≥ 50,000\u002FmcL is allowed in case of bone marrow involvement and\u002For splenomegaly\n* Hemoglobin ≥ 8 g\u002FdL\n* Transfusion and\u002For growth factor support within 7 days (or 14 days in case of long-acting growth factors such as pegylated granulocyte colony-stimulating factor \\[G-CSF\\]) of enrollment to meet these requirements is not permitted\n* Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease or hemolysis in which case bilirubin must be \\\u003C 3 x ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \\\u003C 3 x institutional ULN\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\\u003C 3 x institutional ULN\n* Creatinine clearance \\> 45 mL\u002Fmin calculated by Cockcroft-Gault. Patients on dialysis are not eligible\n* The effects of ibrutinib and epcoritamab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 2 weeks before initiation of treatment, for the duration of study participation and for 12 months after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men must agree to refrain from sperm donation for at least 12 months after the last dose of epcoritamab\n* Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \\[β-hCG\\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study\n* Patients must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document. Voluntary written consent must be given before the performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n\nExclusion Criteria:\n\n* Prior therapy with a bispecific antibody targeting CD3 and CD20\n* Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms\n* Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible\n* Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \\> 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or chronic graft versus host disease AND the patient must not have taken immunosuppressive medications associated with the transplant for at least 1 month before the first scheduled dose of ibrutinib\n* Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5 half-lives prior to starting treatment on trial\n* Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis\n* Known active central nervous system (CNS) involvement by lymphoma. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at the discretion of the principal investigator\n* Active uncontrolled infection or infection requiring intravenous (IV) antibiotic therapy for \\> 2 consecutive days within 2 weeks prior to the first dose of study drug\n* Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or greater), unstable angina, or myocardial infarction within the past 6 months. Poorly controlled or clinically significant atherosclerotic vascular disease including angioplasty, cardiac or vascular stenting within 6 months of enrollment\n* Known liver cirrhosis with moderate to severe hepatic impairment (Child-Pugh class B or C)\n* Clinically significant pulmonary disease or history of bronchospasm requiring intubation, or clinically significant active interstitial lung disease or pneumonitis\n* History of cerebrovascular accident or transient ischemic attack within the 6 months before day 1, cycle 1 of treatment\n* Any prior history of intracranial hemorrhage\n* Clinically significant known bleeding diatheses or platelet dysfunction disorders.\n* Receiving treatment with coumadin\u002Fwarfarin\n* Known gastrointestinal disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of ibrutinib including the inability to swallow pills\u002Fcapsules\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol\n* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent\n* Prior solid organ transplant\n* History of other malignancies that could affect compliance with the protocol or interpretation of results in the opinion of the investigator\n* Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 21 days of the first scheduled dose of ibrutinib (cycle 1 day -7)\n* Known history of HIV, active hepatitis C infection (HCV ribonucleic acid \\[RNA\\] polymerase chain reaction \\[PCR\\]-positive) and\u002For active hepatitis B infections (HBV DNA PCR-positive). If hepatitis B core (HBc) antibody is positive, the patient must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the patient must be evaluated for the presence of HCV RNA by PCR. Patients with positive HBc antibody and negative HBV DNA by PCR are eligible. Patients with positive HCV antibody and negative HCV RNA by PCR are eligible\n* Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib or epcoritamab, breastfeeding should be discontinued if the mother is treated with ibrutinib or epcoritamab\n* Patients with ongoing clinically significant grade ≥ 2 toxicity from prior therapy",{"count":134,"type":20},38,[63,23],"This phase Ib\u002FII trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and\u002For more effective.",[26,138,89,90,30,139,140,33,141,93,94,37,142,143],"Recurrent Grade 3b Follicular Lymphoma","Recurrent Primary Mediastinal Large B-Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","Refractory Grade 3b Follicular Lymphoma","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed Non-Hodgkin Lymphoma","2026-06-02",{"date":146,"type":44},"2026-06-04",{"date":148,"type":44},"2025-04-02",{"date":150,"type":20},"2027-10-31",{"name":152,"class":51},"Yazeed Sawalha",2,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":52},"100551311","phase-2-epcoritamab-car-t-cells-for-large-b-cell-lymphomas-100551311","NCT06458439","Epcoritamab-CAR T Cells for Large B-cell Lymphomas","Phase IIa Trial to Evaluate Epcoritamab Administered Before and After CAR-T Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphomas","Inclusion Criteria:\n\n* Age \\> 18 years\n* Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.\n* Able to comply with the study protocol, in the investigator's judgment\n* ECOG PS of 0 - 2\n* Pathology report confirming eligible diagnosis\n* Documented CD20+ tumor cells on most recent biopsy\n* Patients will have failed to respond to frontline standard of care therapy containing an anthracycline and anti-CD20 antibody\n* Patients will be eligible and consent to be treated with a \"commercially available\" anti-CD19, 4-1BB, CD3zeta CAR-T cell therapy or anti-CD19, CD28, CD3zeta CAR T cell therapy (for example, tisagenlecleucel, lisocabtagene maraleucel, or axicabtagene maraleucel)\n* Patients must have a PET\u002FCT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \\[CT\\] scan with FDG-uptake ≥ liver)\n* Adequate laboratory studies\n* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n* Ability and willingness to take proper contraceptive precautions\n\nExclusion Criteria:\n\n* Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.\n* Prior solid organ transplantation\n* Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.\n* History of autoimmune disease or other diseases resulting in permanent immunosuppression or requiring chronic immunosuppressive therapy (see Exclusion Criteria 5a), with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n  2. Patients with a history of lymphoma-related immune thrombocytopenic purpura or autoimmune hemolytic anemia in remission may be eligible for this study if approved by the Regulatory Sponsor and Principal Investigator\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  i. Rash must cover \\\u003C 10% of body surface area ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroid iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent for \\> 2 weeks) within the previous 3 months d. rheumatoid arthritis or similar autoimmune\u002Frheumatic conditions\n* Systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). However, the following are permitted:\n\n  1. If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control.\n  2. Patients who received a single dose of a systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) may be enrolled\n  3. The use of inhaled corticosteroids is permitted\n  4. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n  5. The use of physiologic doses of corticosteroids (\\\u003C 20 mg\u002Fday of prednisone or equivalent) for uses such as management of adrenal insufficiency is permitted\n* Known past or current malignancy, other than inclusion diagnoses, except for:\n\n  1. Cervical carcinoma of Stage 1B or less.\n  2. Adequately resected, non-metastatic basal cell or squamous cell skin carcinoma.\n  3. Non-invasive, superficial bladder cancer.\n  4. Prostate cancer with a current PSA level \\\u003C0.1 ng\u002FmL.\n  5. Patients with a malignancy that has been treated with curative intent will also be enrolled if that malignancy is in remission prior to first dose of epcoritamab\n* Known clinically significant cardiovascular disease\n* Patients with the following active infection(s) could have increased risks for toxicity if treated with bispecific antibody therapy, thus patient will be excluded if:\n\n  1. Positive serologic or PCR test results for acute or chronic HBV infection. Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov\u002Fhepatitis\u002Fhbv\u002Fpdfs\u002Fserologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation. Patients with a history of hepatitis B who are negative for HBV by PCR, will not be excluded but will be placed on suppressive antiviral therapy\n  2. Acute or chronic HCV infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Patients with a history of hepatitis C who have been adequately treated (negative PCR) will not be excluded.\n  3. Positive serologic or RT-PCR test results for HIV infection.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks of enrollment. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients.\n* Clinically significant pulmonary disease (e.g., bronchospasm and\u002For obstructive pulmonary disease) that requires chronic oxygen or corticosteroid use \\> 20 mg mg\u002Fday prednisone or equivalent\n* Uncontrolled seizure disorder\n* Exposure to live or live attenuated vaccine within 4 weeks prior to signing ICF\n* Pregnancy or breast feeding\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results",{"count":162,"type":20},31,[23],"This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.",[166,167,168,169,170],"Lymphoma, Non-Hodgkin","Relapsed Diffuse Large B Cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma","High-grade B-cell Lymphoma","Transformed Indolent Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-22",{"date":173,"type":44},"2026-05-27",{"date":175,"type":44},"2024-09-24",{"date":177,"type":20},"2027-12",{"name":179,"class":51},"Abramson Cancer Center at Penn Medicine",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100460189","phase-1-testing-the-combination-of-nivolumab-and-astx727-for-relapsed-or-refractory-b-cell-lymphoma-100460189","NCT05272384","Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma","A Phase 1 Study of Nivolumab in Combination With ASTX727 in B-cell Lymphoma (NHL or HL) With an Expansion Cohort in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Hodgkin Lymphoma (HL)","Inclusion Criteria:\n\n* Dose Escalation: Histologically confirmed relapsed or refractory B cell lymphoma (non-Hodgkin lymphoma \\[NHL\\] or Hodgkin lymphoma \\[HL\\])\n* Dose Expansion: Patients must have histologically confirmed relapsed or refractory DLBCL or HL\n* Patients with DLBCL must have failed at least first line chemotherapy and must be transplant ineligible (either secondary to performance status or lack of adequate disease control or patient preference). Patients may be relapsed after autologous or allogeneic stem cell transplant (SCT), or after chimeric antigen receptor (CAR)-T cell therapy\n* In dose escalation patients with HL or B cell NHL other than DLBCL must have relapsed after at least 2 lines of therapy and have no other curative options left. HL patients must be brentuximab vedotin refractory or intolerant. In dose expansion, patients with classic HL must have relapsed after at least 2 lines of therapy, and had autologous stem cell transplantation (ASCT), be ineligible for ASCT, or have refused ASCT. Prior treatment with checkpoint inhibitor is allowed\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of nivolumab in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG)\u002FKarnofsky performance status =\\\u003C 2 (Karnofsky \\>= 70%)\n* Leukocytes \\>= 1,500\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Absolute neutrophil count \\>= 1,000\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Platelets \\>= 75,000\u002FmcL (unless documented bone marrow involvement in which case lower values may be allowed)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Serum creatinine =\\\u003C 1.5 x ULN OR creatinine clearance (CrCl) \\>= 50 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior malignancy that has completed treatment and or in remission for at least 3 years, or non-melanoma skin cancer or in situ cancer are eligible for this trial. Patients with concurrent malignancy or recent treatment for a concurrent malignancy are not eligible\n* Patients should be New York Heart Association Functional Classification of class 2B or better\n* The effects of nivolumab and ASTX727 on the developing human fetus are unknown. For this reason and because DNMTi agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP should use a highly effective contraception method to avoid pregnancy during treatment with ASTX727 and for at least 6 months after the last dose of investigational drug and must agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. Women must not be breastfeeding. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to highly-effective contraceptive measures of birth control and not to father a child while receiving treatment and for a period of 3 months after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n\n  * Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\nWOCBP receiving ASTX727 will be instructed to adhere to contraception for a period of 6 months after the last dose of investigational product. Men receiving ASTX727 and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 3 months after the last dose of investigational product. WOCBP receiving nivolumab as a single agent will be instructed to adhere to contraception for a period of 5 months after the last dose. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately\n\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (2 weeks for Revlimid, 6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who have had prior treatment with anti-PD-1\u002FPD-L1 inhibitors or anti CTLA4 antibodies and were permanently discontinued from further treatment because of an adverse event. All other prior therapies are permissible. Prior checkpoint inhibitor therapy is allowed if there was no discontinuation due to adverse event\n* Patients who are receiving any other investigational agents\n* Patients with known brain metastases or leptomeningeal metastases may be excluded because of poor prognosis and concerns regarding progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or nivolumab, including severe hypersensitivity reaction to any monoclonal antibody\n* Patients with uncontrolled intercurrent illness\n* Patients with cognitive or other impairment that would prevent compliance with study requirements\n* Pregnant women are excluded from this study because ASTX727 is a DNMTi agent and nivolumab is a PD-L1 inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ASTX727 and nivolumab, breastfeeding should be discontinued if the mother is treated with ASTX727 and nivolumab\n* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome (GBS), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study",{"count":188,"type":20},32,[63],"This phase I trial tests the safety, side effects, and best dose of nivolumab in combination with ASTX727 in treating B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. ASTX727 consists of the combination of decitabine and cedazuridine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Giving nivolumab in combination with ASTX727 may shrink and stabilize cancer.",[192,26,193,194,33,195],"Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Hodgkin Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma","Refractory Hodgkin Lymphoma","2026-05-12",{"date":198,"type":44},"2026-05-13",{"date":200,"type":44},"2022-11-03",{"date":202,"type":20},"2027-06-28",{"name":103,"class":104},9,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":52},"100490909","phase-2-loncastuximab-tesirine-and-mosunetuzumab-for-the-treatment-of-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-100490909","NCT05672251","Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase 2 Study of Loncastuximab Tesirine Plus Mosunetuzumab in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n* Be willing to provide tissue from a fresh core or excisional biopsy (performed as standard of care) of a tumor lesion prior to starting study therapy or from diagnostic tumor biopsies.\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma or Follicular Lymphoma Grade 3B according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Life expectancy \\> 12 months.\n* Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma Grade 3B according to the WHO classification, with hematopathology review at the participating institution. Subtypes of DLBCL including transformed indolent lymphomas (TIL) including Richter's Transformation, primary mediastinal large B-cell lymphoma (PMBCL), and high-grade B-cell lymphoma not otherwise specified (HGBCL-NOS) are eligible.\n* Relapsed or refractory disease after \\>= 1 prior line of therapy (prior CD19-directed therapy and prior autologous stem cell transplant are allowed).\n\n  * Relapse at the time of study enrollment must have been confirmed histologically (with hematopathology review at the participating institution). Exceptions may be granted with study PI approval.\n* Measurable disease by computerized tomography (CT) or positron emission tomography (PET)\u002FCT scan with one or more sites of disease \\>= 1.5 cm in longest dimension.\n* Tumor must be positive for both CD19 and CD20 by immunohistochemistry after the most recent therapy.\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C Grade 1 to prior anti-cancer therapy\n* Without bone marrow involvement: Absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* With bone marrow involvement: no minimum ANC requirement.\n\n  * (G-CSF is allowed to reach ANC requirement).\n* Platelets \\>= 75,000\u002Fmm\\^3.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN).\n\n  * If hepatic involvement by lymphoma, or Gilbert's disease: =\\\u003C 3X ULN.\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: AST =\\\u003C 5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n\n  * If hepatic involvement by lymphoma: ALT =\\\u003C 5 x ULN .\n* Creatinine clearance of \\>= 40 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International Normalized Ratio (INR) OR Prothrombin (PT) =\\\u003C 1.5 x ULN.\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants.\n* If not receiving anticoagulants: Activated Partial Thromboplastin Time (aPTT) =\\\u003C 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females of childbearing potential to abstain from heterosexual intercourse or use two adequate method of birth control, including at least 1 method with a failure rate of \\\u003C 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), until 3 months after the final dose mosunetuzumab and 9 months after the last dose of loncastuximab tesirine. Women must refrain from donating eggs during this same period. Agreement by males to abstain from heterosexual intercourse or use a condom with female partners of childbearing potential or pregnant female partners during the treatment period and for 3 months after the final dose of mosunetuzumab and 6 months after the last dose of loncastuximab tesirine. Men must refrain from donating sperm during this same period.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only) with no identified cause other than menopause.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established and proper use of progestogen only hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices. Barrier methods must always be supplemented with the use of a spermicide. Note: Combined oral contraceptives are not recommended.\n\nExclusion Criteria:\n\n* Prior treatment with loncastuximab tesirine.\n* Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies.\n* Prior allogeneic stem cell transplantation.\n* Prior use of any monoclonal antibody, radioimmunoconjugate or ADC within 2 weeks prior to Day 1 of protocol therapy.\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to Day 1 of protocol therapy.\n* Treatment with radiotherapy within 2 weeks prior to Day 1 of protocol therapy.\n\n  * If patients have received radiotherapy within 4 weeks prior to prior to Day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.\n* Autologous stem cell transplantation (SCT) within 30 days prior to prior to Day 1 of protocol therapy.\n* Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to Day 1 of protocol therapy.\n* Live vaccine within 30 days prior to Day 1 of protocol therapy.\n* Concomitant investigational therapy.\n* Treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents(e.g., immune checkpoint inhibitor therapies). Note: For certain prior treatments, such as CAR-T cell therapies, patients with prior immune-related Grade \\>= 3 adverse events (e.g., CRS) may be allowed after discussion with and approval by the Study PI.\n* Systemic steroid therapy or any other form of immunosuppressive therapy for lymphoma symptom control must be tapered down to =\\\u003C 20 mg\u002Fday prednisone or equivalent. Exceptions are:\n\n  * Inhaled or topical steroids\n  * Use of mineralocorticoids for management of orthostatic hypotension\n  * Use of physiologic doses of corticosteroids for management of adrenal insufficiency\n* Known hypersensitivity to biopharmaceutical produced in chinese hamster ovary (CHO) cells or history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).\n* History of solid organ transplantation.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Clinically significant uncontrolled illness.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen \\[HBsAg\\] and positive hepatitis B core antibody \\[HBcAb\\]) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Testing to be done only in patients suspected of having infections or exposures.\n* Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \\> 200 and are on HAART medication are allowed. Testing to be done only in patients suspected of having infections or exposures.\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection.\n* Known active central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement.\n* History of erythrema multiforme, Grade \\>= 3 rash, or blistering following prior treatment with immunomodulatory derivatives.\n* Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event\u002Fstroke or myocardial infarction within the past 6 months.\n* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis.\n* Active autoimmune disease requiring treatment.\n* History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible.\n* Recent major surgery (within 4 weeks) prior to start of protocol therapy, other than for diagnosis.\n* History of another primary malignancy that has not been in remission for at least 2 years, with the following exceptions:\n\n  * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\n  * Adequately treated in situ carcinomas (e.g. cervical, esophageal) without evidence of disease\n  * Asymptomatic prostate cancer managed with a watch-and-wait strategy\n  * If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI).\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":213,"type":20},36,[23],"This phase II trial studies the safety and how well of loncastuximab tesirine when given together with mosunetuzumab works in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, loncastuximab, linked to a toxic agent called tesirine. Loncastuximab attaches to anti-CD19 cancer cells in a targeted way and delivers tesirine to kill them. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving loncastuximab tesirine with mosunetuzumab may help treat patients with relapsed or refractory diffuse large B-cell lymphoma.",[26,138,217,218,219,220,33,141,221,222,223,224],"Recurrent High Grade B-Cell Lymphoma","Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Transformed Chronic Lymphocytic Leukemia","Recurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","Refractory High Grade B-Cell Lymphoma","Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Refractory Transformed Chronic Lymphocytic Leukemia","Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-07",{"date":227,"type":44},"2026-05-11",{"date":229,"type":44},"2024-01-02",{"date":231,"type":20},"2027-03-23",{"name":233,"class":51},"City of Hope Medical Center",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":52},"100576394","phase-2-odronextamab-for-relapsed-and-refractory-large-b-cell-lymphomas-before-car-t-100576394","NCT06784726","Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T","Odronextamab for Relapsed\u002FRefractory Large B-Cell Lymphomas Before Definitive Lymphoma-Directed Therapies","Inclusion Criteria:\n\n* Histologically confirmed large B cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from indolent lymphoma, follicular lymphoma (FL) grade 3B\n* Measurable disease, defined as at least one measurable lesion ≥ 15 mm on PET, CT, or magnetic resonance imaging (MRI) within one month of screening, according to the International Working Group consensus response evaluation criteria in lymphoma\n* Prior frontline therapy for large B cell lymphoma must have failed the patient, and criteria must be met for receiving commercial axicabtagene ciloleucel (axi-cel), lisocabtagene maraleucel (liso-cel), or tisagenlecleucel (tisa-cel) per Food and Drug Administration (FDA) label\n* Age ≥ 18 years\n* Capable of understanding and providing a written informed consent\n* Prior treatment with an anti-CD20 antibody therapy\n* Eastern Cooperative Oncology Group performance status of 0-1; we allow enrollment of patients with a performance status of 2 if it is attributed to lymphoma per discretion of the treating physician or principal investigator (PI)\n* Creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault equation\n* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x the ULN\n* Adequate pulmonary function, defined as ≤ grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% on room air\n* Adequate cardiac function, defined as left ventricular ejection fraction ≥ 50% and without evidence for pericardial effusion\n* Platelet count ≥ 75 x 10\\^9 \u002FL\n* Hemoglobin (Hg) level ≥ 9 g\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Platelet count ≥ 25 x 10\\^9 \u002FL\n* Patients with bone marrow involvement or splenic sequestration: Hg ≥ 7.0 g\u002FdL\n* Patients with bone marrow involvement or splenic sequestration: ANC ≥ 0.5 x 10\\^9 \u002FL\n* Negative serum pregnancy test within 2 days of initiating odronextamab for women of childbearing potential (WOCBP), defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year\n* Fertile male and WOCBP patients must be willing to use highly effective contraceptive methods from study recruitment to at least 6 months after the CAR T-cell infusion\n* Patients must not provide egg or sperm donation until at least 6 months after the completion of the last dose of Odron\n\nExclusion Criteria:\n\n* Detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. Patients with a history of secondary central nervous system (CNS) lymphoma may be eligible provided that there has been no evidence of CNS disease from lymphoma for at least 3 months at the time of screening\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n* Standard anti-neoplastic chemotherapy (non-biologic) within 5-times the half-life or within 2 weeks, whichever is shorter, prior to first administration of study drug\n* Standard radiotherapy within 2 weeks of first administration of study drug\n* Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy, unless all the following are met: disease responded to prior bispecific therapy (CR or PR per Lugano criteria) and did not experience disease progression within 12 months of the last dose of prior bispecific therapy, and the tumor must still express CD20 (CD20 examination per standard of care \\[SOC\\])\n* Allogeneic stem cell transplantation\n* Any CAR-T cell therapy\n* Patients may not be receiving other investigational agents\n* Treatment with rituximab, alemtuzumab, or other investigational or commercial biologic agent within 2 weeks prior to first administration of study drug\n* Immunosuppressive therapy (other than biologic) within 2 weeks of first administration of study drug\n* Treatment with an investigational non-biologic agent within 2 weeks of first administration of study drug\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition of study drug\n* History of hypersensitivity to any compound in the tetracycline antibiotics group\n* Concurrent active malignancy for which the patient is receiving systemic treatment, unless approved by PI\n* Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection\n* Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) and\u002For significant pulmonary disease (e.g., obstructive pulmonary disease and history of symptomatic bronchospasm)\n* Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg\u002Fday of prednisone or equivalent. A short course of corticosteroid for lymphoma disease control during screening is allowed\n* Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 400) or chronic infection with hepatitis B virus or hepatitis C virus. Patients with hepatitis B (hepatitis B surface antigen positive \\[HepBsAg+\\]) with controlled infection were permitted upon consultation with the physician managing the infection\n* Known hypersensitivity to both allopurinol and rasburicase\n* Pregnant or breast-feeding women\n* Administration of live vaccination within 28 days of first administration of study drug",{"count":242,"type":20},27,[23],"This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease control and to increase the chance of successful receipt of CAR-T cell therapy. However, bridging therapy is typically given after leukapheresis, which does not help prevent disease progression between the decision for CAR-T cell therapy and leukapheresis. Giving odronextamab as bridging therapy before leukapheresis may delay disease progression to allow leukapheresis and increase the likelihood of successful CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphomas.",[26,27,138,217,139,220,33,34,141,221,142,224],"2026-05-04",{"date":248,"type":44},"2026-05-06",{"date":250,"type":44},"2025-09-04",{"date":252,"type":20},"2033-04-11",{"name":254,"class":51},"University of Washington",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":52},"100582107","phase-1-zanubrutinib-in-combination-with-sonrotoclax-for-the-treatment-of-underrepresented-ethnic-and-racial-minorities-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-100582107","NCT06859008","Zanubrutinib in Combination With Sonrotoclax for the Treatment of Underrepresented Ethnic and Racial Minorities With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","Feasibility of Treating Relapsed\u002FRefractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic\u002FRacial Minorities","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years on the day of signing the informed consent form\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Patients are of the following self-identified racial\u002Fethnic groups:\n\n  * Cohort 1: Patients in any of the following categories:\n\n    * Black or African American\n    * Hispanic or Latino\n    * American Indian\u002FNative Alaskan\n    * Pacific Islander\u002FNative Hawaiian\n    * Any other patient that does not fit the definition of Cohort 2\n  * Cohort 2: Patients in either of following categories:\n\n    * Non-Hispanic White\n    * Non-Hispanic Asian\n* Confirmed diagnosis (per World Health Organization \\[WHO\\] guidelines, unless otherwise noted) of one of the following disease subtypes. Note that for disease subtypes that are known to respond to BTK inhibitor (BTKi) and\u002For BCL2 inhibitor (BCL2i) (e.g., marginal zone lymphoma \\[MZL\\], mantle cell lymphoma \\[MCL\\], CLL\u002FSLL), newly diagnosed or r\u002Fr patients are allowed\n\n  * Diffuse large B cell lymphoma (DLBCL)\n\n    * R\u002FR DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 2 prior lines of therapy. Patients should be considered by the investigator to be refractory to or not a candidate for approved therapies with proven efficacy including but not limited to chimeric antigen receptor (CAR) T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Follicular lymphoma (FL)\n\n    * R\u002FR FL (grade 1, 2 or 3a based on WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy. Patients should be considered by the investigator for all approved therapies with proven efficacy including but not limited to CAR T cell therapy or bispecific antibody therapy\n    * Active disease requiring treatment\n  * Marginal zone lymphoma (MZL)\n\n    * R\u002FR extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy\n    * Active disease requiring treatment\n  * Mantle cell lymphoma (MCL)\n\n    * R\u002FR MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy\n    * Requiring treatment in the opinion of the investigator\n  * Chronic lymphocytic leukemia\u002Fsmall lymphocytic leukemia (CLL\u002FSLL)\n\n    * CLL\u002FSLL diagnosis that meets the International Workshop on CLL (International Workshop on Chronic Lymphocytic Leukemia \\[IWCLL\\]) criteria\n    * Patients with previously untreated and\u002For r\u002Fr CLL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy will be included\n    * Patients must have an indication to start treatment\n* Measurable disease, defined as:\n\n  * CLL: at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) or clonal lymphocytes measured by flow cytometry\n  * DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \\> 1.5 cm in longest diameter OR 1 extranodal lesion \\> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT\u002FMRI. For MZL, isolated splenomegaly is considered measurable for this study. For MCL, clonal lymphocytes measured by flow cytometry is considered measurable\n* Life expectancy of ≥ 6 months\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: Platelets ≥ 30,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 7g\u002FdL\n\n  * NOTE: Red blood cell transfusions are not permitted within 7 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* Fridericia's formula-corrected QT interval (QTcF) ≤ 480 ms\n\n  * Note: Performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 90 days after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Major surgery ≤ 4 weeks of the first dose of study drug\n* Prior autologous stem cell transplant unless ≥ 30 days after transplant; or prior chimeric antigen receptor T cell (CAR-T) therapy unless ≥ 30 days after cell infusion\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* Prior therapy ≥ 2 months with or progression on a Bcl2 inhibitor (eg, venetoclax)\n* Vaccination or requirement for vaccination with a live vaccine within 35 days prior to the first dose of study drug or at any time during planned study treatment\n* Requires ongoing treatment with a strong CYP3A inducer\n* Requires ongoing treatment with warfarin or warfarin derivatives\n* Concurrent participation in another therapeutic clinical trial\n* Use of the following substances prior to the first dose of study drug:\n\n  * ≤ 28 days before first dose of study drug: Any biologic and\u002For immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, eg, rituximab, and\u002For cancer vaccine therapy)\n  * ≤ 14 days before the first dose of study drug: systemic chemotherapy or radiation therapy\n  * ≤ 7 days before the first dose of study drug: corticosteroid given with antineoplastic intent other than control of BTK inhibitor withdrawal flare\n  * ≤ 5 half-lives before the first dose of study drug: BTK inhibitor, tyrosine kinase inhibitor, or other targeted small molecule given with antineoplastic intent\n* Known current central nervous system involvement by lymphoma\u002Fleukemia\n* Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome\n* Any uncontrolled or clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction (MI) within 6 months before screening\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Unstable angina within 3 months before screening\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n* Severe or debilitating pulmonary disease\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Active fungal, bacterial and\u002For viral infection requiring systemic therapy\n* Underlying medical conditions that, in the investigator's opinion, will render the administration of study drugs hazardous or obscure the interpretation of toxicity or adverse events (AEs)\n* Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows:\n\n  * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable (\\\u003C 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation\n  * Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable\n* Any condition which in the discretion of the investigator would compromise the ability to comply with study procedures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura)\n* Females only: Pregnant or breastfeeding\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":263,"type":20},37,[63],"This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.",[267,268,26,269,270,271,272,273,31,274,275,33,276,277,278,279,280,38,281],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Recurrent Grade 1 Follicular Lymphoma","Recurrent Grade 2 Follicular Lymphoma","Recurrent Grade 3a Follicular Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Splenic Marginal Zone Lymphoma","Refractory Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue","Refractory Grade 1 Follicular Lymphoma","Refractory Grade 2 Follicular Lymphoma","Refractory Grade 3a Follicular Lymphoma","Refractory Mantle Cell Lymphoma","Refractory Splenic Marginal Zone Lymphoma","2026-04-16",{"date":284,"type":44},"2026-04-20",{"date":286,"type":44},"2025-08-25",{"date":288,"type":20},"2029-01-31",{"name":233,"class":51},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100317852","phase-2-ascorbic-acid-and-chemotherapy-for-the-treatment-of-relapsed-or-refractory-lymphoma-ccus-and-chronic-myelomonocytic-leukemia-100317852","NCT03418038","Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia","Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed\u002F Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted \\> 6 months; refractory is no response or relapse within 6 months; previous biopsies \\\u003C 6 months prior to treatment on this protocol will be acceptable\n\n  * NOTE: Arms A\u002FB - relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\n  * NOTE: Arm C patients include relapsed or refractory lymphoma patients of any type for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed or refractory double-hit high grade lymphoma patients and relapsed or refractory Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding\n* Measurable or assessable disease: measurable disease is defined as measurable by computed tomography (CT) \\[dedicated CT or the CT portion of a positron emission tomography (PET)\u002FCT\\] or magnetic resonance imaging (MRI): to be considered measurable, there must be at least one lesion that has a single diameter of \\>= 1.5 cm\n\n  * NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler; patients with assessable disease by PET are also eligible as long as the assessable disease is biopsy proven lymphoma\n* Arms A\u002FB - eligible for treatment with ifosfamide, carboplatin, and etoposide (+\u002F- rituximab)\n* Arm C eligible for treatment with one of the following standard, every 3 week, platinum-based salvage regimens (with or without monoclonal antibody as appropriate for the disease):\n\n  * Ifosfamide\u002Fcarboplatin\u002Fetoposide (ICE) or rituximab\u002Fifosfamide\u002Fcarboplatin\u002Fetoposide (RICE);\n  * Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or RDHAP;\n  * Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);\n  * Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);\n  * Oxaliplatin, cytosine arabinoside, dexamethasone (OAD) or rituximab, oxaliplatin, cytosine arabinoside, dexamethasone (ROAD)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\>= 8.0 g\u002FdL (may transfuse to meet this requirement), obtained =\\\u003C 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Platelet count \\>= 75000\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN), obtained =\\\u003C 14 days prior to registration\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement), obtained =\\\u003C 14 days prior to registration\n* Creatinine =\\\u003C 1.6 mg\u002FdL; if over 1.6 then the calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula, obtained =\\\u003C 7 days prior to registration\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) test done =\\\u003C 14 days prior to registration\n\n  * If positive, the CD4 count must be \\> 400\n* Provide written informed consent\n* Willingness to have a central venous line \\[peripherally inserted central catheter (PICC) or PORT\\]\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM D: Patients who had a diagnosis of CCUS with one or more TET2 mutations or TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2) or epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2). CCUS diagnosis being defined based on the absence of definitive morphologic evidence of hematologic neoplasms from bone marrow biopsy evaluation combined with evidence of pathogenic myeloid somatic mutation with a variant allele frequency (VAF) of at least 2% using our institution's next generation sequencing (NGS) panel (OncoHeme, Mayo Clinic)\n* ARM D: ECOG performance status (PS) 0, 1 or 2\n* ARM D: Patients must meet at least 1 of these 3 laboratory criteria to be enrolled:\n\n  * Hemoglobin =\\\u003C 10g\u002FdL (obtained =\\\u003C 7 days prior to registration)\n  * Absolute neutrophil count (ANC) =\\\u003C 1000\u002Fmm\\^3 (obtained =\\\u003C 7 days prior to registration)\n  * Platelet count =\\\u003C 100,000\u002Fmm\\^ 3 (obtained =\\\u003C 7 days prior to registration)\n* ARM D: Total bilirubin =\\\u003C 2 x ULN (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Creatinine =\\\u003C 1.6 mg\u002FdL (obtained =\\\u003C7 days prior to registration). If \\> 1.6, then the Calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM D: Negative pregnancy test, for persons of childbearing potential only (obtained =\\\u003C 7 days prior to registration). NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* ARM D: Provide written informed consent\n* ARM D: Willingness to have a central venous line (PICC or PORT)\n* ARM D: Willingness to provide mandatory blood specimens for correlative research\n* ARM D: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM D: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM E PRE-REGISTRATION: Age ≥ 18 years\n* ARM E PRE-REGISTRATION: New or an established diagnosis of 2016 World Health Organization (WHO) defined chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation requiring treatment with DNA methyltransferase inhibitors\u002Fhypomethylating agents\n* ARM E PRE-REGISTRATION: No prior CMML directed therapy.\n\n  * Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. NOTE: Prior exposure to hydroxyurea is allowed. Continuation beyond the first cycle must be discussed with the principal investigator (PI)\n* ARM E PRE-REGISTRATION: Creatinine ≤ 1.6 mg\u002FdL. If \\> 1.6, then the Calculated creatinine clearance must be ≥ 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM E PRE-REGISTRATION: Willingness to provide mandatory research bone marrow sample for correlative research\n* ARM E PRE-REGISTRATION: ECOG performance status (PS) 0, 1, or 2\n* ARM E PRE-REGISTRATION: Provide written informed consent\n* ARM E REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* ARM E REGISTRATION: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM E REGISTRATION: Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* ARM E REGISTRATION: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Platelet count ≥ 20,000\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Total bilirubin ≤ 1.5 x ULN ( ≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Ability to complete questionnaire by themselves or with assistance\n* ARM E REGISTRATION: For a person of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study. Adequate contraception is defined as follows:\n\n  * Complete true abstinence\n  * Consistent and correct use of one of the following methods of birth control:\n\n    * Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient\n    * Implants of levonorgestrel\n    * Injectable progestogen\n    * Intrauterine device (IUD) with a documented failure rate of less than 1% per year\n    * Oral contraceptive pill (either combined or progesterone only)\n    * Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen\n* ARM E REGISTRATION: WOCBP must have a negative serum or urine pregnancy test ≤ 7 days prior to registration. NOTE: WOCBP include any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\> 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL. Even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* ARM E REGISTRATION: Persons who are able to father a child must use contraception during the study and for 3 months after the last treatment dose.\n\n  * Complete true abstinence\n  * Latex condom with a spermicidal agent\n  * Diaphragm with spermicide\n* ARM E REGISTRATION: Willingness to have a central venous line (PICC or PORT)\n* ARM E REGISTRATION: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any therapy =\\\u003C 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretion. Exception: Palliative radiation is allowed\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the lymphoma\n* Other active malignancy than lymphoma\n\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer that could interfere with this protocol therapy; patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria; patients with non-melanotic skin cancer may enroll\n* History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* Patients with active central nervous system (CNS) lymphoma or active cerebrospinal fluid (CSF) involvement with malignant cells requiring CNS-specific therapy with IV or intrathecal (IT) methotrexate (MTX); Note: Patients with any prior CNS lymphoma (parenchymal or leptomeningeal) MUST be in complete remission (CR) in those compartments without any maintenance therapy required\n* Patients with uncontrolled or symptomatic kidney stones\n* Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Bona-fide hematological neoplasm\n* ARM D: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* ARM D: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM D: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM D: History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM D: Patients with uncontrolled or symptomatic kidney stones\n* ARM D: Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E PRE-REGISTRATION: Myelodysplastic syndrome (MDS)\u002Fmyeloproliferative neoplasm (MPN) overlap syndromes other than CMML\n* ARM E PRE-REGISTRATION: Active central nervous system disease\n* ARM E PRE-REGISTRATION: Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* ARM E PRE-REGISTRATION: Concurrent active malignancy, except adequately treated nonmelanoma skin cancer. History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for \\> 2 years\n* ARM E PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM E PRE-REGISTRATION: Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of ≥ 20 mg\u002Fday prednisone (or equivalent). Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids\n* ARM E PRE-REGISTRATION: Patients with uncontrolled or symptomatic kidney stones\n* ARM E REGISTRATION: New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* ARM E REGISTRATION: History of myocardial infarction ≤ 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM E REGISTRATION: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac arrhythmia, unstable angina pectoris, clinically significant nonhealing or healing wounds, pulmonary congestion or pulmonary edema, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, clinical dehydration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM E REGISTRATION: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception",{"count":298,"type":20},80,[23],"This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.\n\nArms A, B, C, and D are closed to enrollment.",[302,303,26,193,304,33,305,306],"Clonal Cytopenia of Undetermined Significance","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent Lymphoma","Refractory Lymphoma","Chronic Myelomonocytic Leukemia","2026-04-13",{"date":282,"type":44},{"date":310,"type":44},"2018-03-23",{"date":312,"type":20},"2033-11-02",{"name":314,"class":51},"Mayo Clinic",4,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":21,"phases":325,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":341,"locationsCount":344},"100445214","phase-1-immune-cell-therapy-car-t-for-the-treatment-of-patients-with-hiv-and-b-cell-non-hodgkin-lymphoma-100445214","NCT05077527","Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma","Axicabtagene Ciloleucel in Relapsed or Refractory HIV-Associated Aggressive B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Participant with age \\>= 18 years at the time of consent. Because no dosing or adverse event data are currently available on the use of axicabtagene ciloleucel in participants \\\u003C 18 years of age, children are excluded from this study\n* Participant is able to understand and willing to sign a written informed consent document before any study procedures\n* Participant must have R\u002FR aggressive B-cell NHL of the following histologies:\n\n  * Diffuse large B-cell lymphoma (DLBCL, including transformed from indolent histology)\n  * High-grade B-cell lymphoma\n  * Primary mediastinal B-cell lymphoma\n  * Follicular lymphoma, grade 3B\n* Participant must have been treated with an anthracycline and rituximab (or other CD20-targeted agent) and have R\u002FR disease after at least 2 lines of therapy\n\n  * At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent\n* Evaluable disease as either:\n\n  * Positron emission tomography (PET)-positive disease according to the \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\", or\n  * Bone marrow involvement assessed by bone marrow biopsy\n* Eastern Cooperative Oncology Group ECOG performance status =\\\u003C 1 (Karnofsky \\>= 60%)\n* Serum creatinine =\\\u003C 1.5 x age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2 (within 4 weeks before enrollment)\n* Alanine aminotransferase (ALT) =\\\u003C 5 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (or \\\u003C 3.0 mg\u002FdL for subjects with Gilbert's syndrome or lymphomatous infiltration of the liver or if taking atazanavir or indinavir (within 4 weeks before enrollment)\n* Adequate pulmonary function, defined as =\\\u003C Common Terminology Criteria for Adverse Events (CTCAE) grade 1 dyspnea and oxygen saturation (SaO2) \\>= 92% on room air (within 4 weeks before enrollment)\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 1 month of determination of eligibility\n* Absolute neutrophil count: \\>= 1,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Platelets: \\>= 75,000\u002Fmm\\^3 (within 4 weeks before enrollment)\n* Total bilirubin: =\\\u003C 1.5 x institutional upper limit of normal (ULN) (3.0 x ULN for patients with Gilbert syndrome) If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\\\u003C 3.5 mg\u002FdL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and ALT =\\\u003C 3 x the upper limit of normal (within 4 weeks before enrollment)\n* Adequate vascular access for leukapheresis procedure and for administration of the cellular product (either peripheral line or leukapheresis catheter)\n* Participants who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy\n* The effects of axicabtagene ciloleucel on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry, for the duration of study participation, and 12 months after the last dose of axicabtagene ciloleucel. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Men who have partners of childbearing potential must agree to use an effective barrier contraceptive method before study entry, for the duration of study participation, and for 1 year after the last dose of axicabtagene ciloleucel\n* Documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care investigator;\n  * Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \\[PrEP\\]) by a licensed health care investigator. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL;\n\n    * Any federally approved, licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. NOTE: A \"licensed\" assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies\n* HIV viral load below 50 copies\u002FmL by FDA-approved assays within 4 weeks prior to registration\n* A CD4 cell count must be obtained within 4 weeks before enrollment at any U.S. laboratory that has a clinical laboratory improvement amendments (CLIA) certification or its equivalent. Twenty participants will be studied with a goal to enroll a minimum of 6 participants with a CD4 \\\u003C100 cells\u002FuL\n* Participants who have hepatitis C (reactive anti-HCV antibody) and hepatitis B (HBsAg positive and\u002For anti-HBc-Total positive), may be enrolled, provided total bilirubin is =\\\u003C 1.5 x institutional upper limit of normal (ULN), AST (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and ALT (serum glutamic pyruvic transaminase \\[SGPT\\]) must be =\\\u003C 3 X institutional upper limit of normal, and HBV deoxyribonucleic acid (DNA) \\\u003C100 IU\u002FmL (if hepatitis B positive) within 4 weeks before enrollment. There must be no evidence of cirrhosis present\n* Participants with hepatitis B core antibody positive must be on an antiviral agent to suppress hepatitis B throughout the study and be willing to continue therapy for at least one year after axicabtagene infusion\n* Participants who are willing to continue ART during leukapheresis, manufacturing and infusion and post infusion of axicabtagene ciloleucel\n\nExclusion Criteria:\n\n* Participants felt to have a high prospect of clinically benefiting from autologous transplantation\n* Participants with central nervous system (CNS)-only involvement by malignancy (note: participants with secondary CNS involvement are allowed on study\n* Participants with a second prior or concurrent malignancy that, in the opinion of the investigator, has a natural history or treatment course that has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Treatment with alemtuzumab within 6 months before anticipated leukapheresis, or treatment with fludarabine or cladribine within 3 months before anticipated leukapheresis\n* Participants with uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or other treatment at the time of enrollment\n* Presence of acute or chronic graft-versus-host disease\n* History of any one of the following cardiovascular conditions within the past 6 months: class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n* Pregnant or nursing women. NOTE: Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours before starting conditioning chemotherapy. Pregnant women are excluded from this study because axicabtagene ciloleucel has not been studied in pregnant women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with axicabtagene ciloleucel, breastfeeding should be discontinued if the mother is treated with axicabtagene ciloleucel. These potential risks may also apply to other agents used in this study\n* Use of the following:\n\n  * Therapeutic doses of corticosteroids (defined as \\> 20 mg\u002Fday prednisone or equivalent) within 7 days before leukapheresis or 72 hours before axicabtagene ciloleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted\n  * Chemotherapy given after leukapheresis to maintain disease control must be stopped \\>= 7 days before conditioning chemotherapy\n  * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week before leukapheresis. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to leukapheresis\n  * Lymphotoxic chemotherapeutic agents (e.g., cyclophosphamide, ifosfamide, bendamustine) within 2 weeks before leukapheresis\n  * Experimental agents received within 4 weeks before leukapheresis unless no response or disease progression is documented while on the experimental therapy and at least 3 half-lives have elapsed before leukapheresis\n  * Immunosuppressive therapies within 4 weeks before leukapheresis and axicabtagene ciloleucel administration (e.g., calcineurin inhibitors, methotrexate, or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R)\n  * Donor lymphocyte infusions (DLI) within 6 weeks before axicabtagene ciloleucel administration\n  * Radiation within 1 week before leukapheresis. Subjects must have progressive disease in irradiated lesions or have additional non-irradiated, PET-positive lesions to be eligible. However, palliative radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks before leukapheresis\n  * Prior receipt of CAR T-cell therapy\n* Participants with signs or symptoms indicative of active CNS involvement are excluded from the protocol, with the following exceptions: The following patients are included in the protocol:\n\n  * Participants with previously treated CNS involvement by lymphoma or leukemia, who and have no neurologic symptoms and no evidence of active lymphoma or leukemia in the CNS by total spine and brain gadolinium enhanced magnetic resonance imaging (MRI) within 2 weeks before leukapheresis and no neurologic progression prior to axicabtagene ciloleucel (axi-cel) infusion\n  * Participants with active CNS involvement and stable neurologic symptoms for at least 3 weeks before leukapheresis and without neurologic progression prior to axi-cel infusion. These patients should have assessment by a total spine and brain gadolinium enhanced MRI within 5 days before axi-cel infusion to document the extent of CNS disease prior to axi-cel infusion. Cerebrospinal fluid (CSF) sampling for cell count, cytology and cell markers by flow cytometry should also be included within 5 days of axi-cel infusion if previously positive\n* Inhaled or topical steroids and adrenal replacement doses =\\\u003C 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, including if \\>= 10 mg\u002Fday prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted. Use of anabolic steroids is permitted\n* The participant has not recovered to baseline or CTCAE =\\\u003C grade 1 from toxicity due to all prior therapies except =\\\u003C grade 2 alopecia, neuropathy, and other non-clinically significant adverse events (AEs), provided that all other eligibility criteria are met\n* Opportunistic infection within the last 3 months, with the exception of oropharyngeal candidiasis\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to axicabtagene ciloleucel or other agents used in study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness with potential to limit compliance with study requirements",{"count":324,"type":20},20,[63],"This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.",[328,329,330,26,138,217,331,218,332,33,141,221,333,222,334],"AIDS-Related Diffuse Large B-cell Lymphoma","AIDS-Related Non-Hodgkin Lymphoma","HIV Infection","Recurrent Non-Hodgkin Lymphoma","Recurrent Transformed B-Cell Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Refractory Transformed B-Cell Non-Hodgkin Lymphoma","2026-04-09",{"date":337,"type":44},"2026-04-14",{"date":339,"type":44},"2025-02-13",{"date":288,"type":20},{"name":342,"class":343},"AIDS Malignancy Consortium","NETWORK",6,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":52},"100596206","phase-2-fecal-microbiome-transplant-to-remodel-intestinal-microbiota-for-patients-with-relapsed-or-refractory-lymphoma-with-exposure-to-high-risk-antibiotics-who-are-receiving-chimeric-antigen-receptor-t-cells-100596206","NCT07042438","Fecal Microbiome Transplant to Remodel Intestinal Microbiota for Patients With Relapsed or Refractory Lymphoma With Exposure to High-Risk Antibiotics Who Are Receiving Chimeric Antigen Receptor T Cells","A Phase 2 Randomized Trial of Remodeling Intestinal Microbiota Using Fecal Microbiome Transplant (FMT) Among Recipients of Chimeric Antigen Receptor T Cells (CAR T)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 60\n* Confirmed diagnosis of relapsed\u002Frefractory CD19 B-cell lymphomas of diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), or double-hit lymphoma (DHL) and scheduled to receive commercial CAR T treatment of YESCARTA ® for their diagnosis\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Exposure to high-risk antibiotics within 90 days of consent. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam, and vancomycin\n* Clinical laboratory and organ function criteria per standard of care to CAR T patients at City of hope: (To be performed within 30 days prior to leukapheresis)\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative)\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 12 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Major surgery in 4 months preceding enrollment\n* No live vaccine in 30 days prior to enrollment\n* Inability to swallow capsules or history of disorder with Inability to swallow FMT capsules\n* History of inflammatory bowel disorder, irritable bowel disorder\n* Severe food allergies\n* History of chronic aspiration\n* History of behavioral disorders including substance abuse disorders which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment\n* History neurocognitive disorder which per discretion of primary investigator will interfere with safe conduct and compliance to study treatment\n* Diagnosis of primary immunodeficiency\n* Active second malignancy requiring treatment except non-melanoma skin cancer or carcinoma in situ-cervix, bladder or to non-metastatic prostate cancer which does not require treatment\n* Uncontrolled bacterial, fungal, or viral infection confirmed using clinical, laboratory and radiological findings requiring administration of intravenously (IV) antimicrobials\n* Any clinical, laboratory or radiologic findings per discretion of primary investigator will interfere with safe conduct of study treatment and compliance with study procedures\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":353,"type":20},56,[23],"This phase II trial tests how well fecal microbiome transplantation works to remodel intestinal microbiota for patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) with exposure to high-risk antibiotics who are receiving chimeric antigen receptor (CAR) T cells. Fecal microbiome transplantation consists of fecal microbiota from healthy donors with healthy gut microbiota that allows re-population of the patient's microbiome with diverse protective microorganisms. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Part of the treatment for CAR T therapy involves high doses of chemotherapy. This, along with prior exposure to high strength antibiotics, can damage patient's intestinal microbiota. Giving fecal microbiome transplantation may improve clinical response by repairing intestinal microbiota for patients with relapsed or refractory lymphoma who had exposure to high-risk antibiotics.",[26,89,32,33,93,39],"2026-03-03",{"date":359,"type":44},"2026-03-05",{"date":361,"type":44},"2026-02-11",{"date":363,"type":20},"2029-01-23",{"name":233,"class":51},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":52},"100530830","phase-1-b-cell-activating-factor-receptor-baffr-based-chimeric-antigen-receptor-t-cells-with-fludarabine-and-cyclophosphamide-lymphodepletion-for-the-treatment-of-relapsed-or-refractory-b-cell-hematologic-malignancies-100530830","NCT06191887","B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies","Phase 1a\u002F1b Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells (MC10029) in Subjects With Relapsed or Refractory BAFFR-Expressing B-Cell Hematologic Malignancies","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL\u002FSLL\n\n  * For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:\n\n    * Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria\n    * Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:\n    * Demonstration of progressive or stable disease by PET\u002FCT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma\n* PRE-REGISTRATION: Disease Specific prior lines of therapies below:\n\n  * For CLL\u002FSLL, patients must have received ≥ two prior lines of therapy, and\u002For ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months\n\n    * These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).\n  * For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.\n  * For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.\n\n    * NOTE: Prior CD19 directed CART must have a 100-day washout period.\n  * For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator.\n\n    * NOTE: Prior failed CD19 directed CART must have a 100-day washout period\n  * For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.\n  * 100-day washout period starts from the date of the last prior CAR-T infusion.\n* PRE-REGISTRATION: Measurable disease\n* REGISTRATION: Positive BAFFR test\n* REGISTRATION: Measurable disease\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* REGISTRATION: Hemoglobin ≥ 9.0 g\u002FdL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration\n* REGISTRATION: Platelet count ≥100,000\u002Fmm\\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration\n* REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration\n* REGISTRATION: Prothrombin time (PT)\u002Finternational normalized ratio (INR) \u002Factivated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration\n\n  * Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT\u002FINR measurements \\> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study\n* REGISTRATION: Calculated creatinine clearance ≥45 ml\u002Fmin using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration\n* REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures\n* REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%\n* REGISTRATION: Patients must have pulse ox measurements of \\> 92% on room air\n* REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* REGISTRATION: Willing to return to enrolling institution for study follow-up\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Prior solid organ transplantation\n* PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration\n* PRE-REGISTRATION: Prior anti-BAFF-R therapies\n* PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy\n* PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration\n* PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R\n* PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration\n* PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Previous or concurrent malignancy\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \\* Persons of childbearing potential who are pregnant or breastfeeding\n  * Life Expectancy of \\\u003C 6 weeks\n  * Persons requiring systemic corticosteroids (\\>10 mg prednisone or equivalent per day) and\u002For other immunosuppressive therapy. Patients are allowed to use topical corticosteroids\n  * Any other conditions that would limit compliance with study requirements\n* PRE-REGISTRATION: Detectable malignant cells from cerebrospinal fluid (CSF) or magnetic resonance imaging (MRI) indicating brain metastases during screening, or a history of central nervous system (CNS) involvement by malignancy (CSF or imaging) with still active disease. Note: Patients with a history of CNS involvement resolving after treatment and without active disease will be considered eligible if other inclusion criteria are met\n* PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration\n* PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT\n* PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients\n* PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure\n* REGISTRATION: Eligible for auto-HCT based on investigator judgement\n* REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment\n* REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility\n* REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration\n* REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding\n* REGISTRATION: Life expectancy of \\\u003C 6 weeks",{"count":242,"type":20},[63],"This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.",[376,377,26,378,273,379,380,219,381,33,382,280,383,384,223],"B-Cell Non-Hodgkin Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Marginal Zone Lymphoma","Recurrent Small Lymphocytic Lymphoma","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma",{"date":386,"type":44},"2026-02-13",{"date":388,"type":44},"2024-03-18",{"date":390,"type":20},"2040-12-31",{"name":314,"class":51},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":400,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":52},"100500757","early-phase-1-evaluation-of-bridging-radiation-therapy-before-car-t-cell-infusion-for-the-treatment-of-relapsed-or-refractory-large-b-cell-lymphoma-100500757","NCT05800405","Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma","A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2 or Karnofsky Performance Status (KPS) \\>= 60.\n* Histologically confirmed large B-cell lymphoma.\n* Relapsed\u002Frefractory disease.\n* Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.\n* 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.\n* Measurable disease e.g., at least 1.5 cm on CT\u002FMRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).\n* Fully recovered from the acute toxic effects (except alopecia) to =\\\u003C grade 1 to prior anti-cancer therapy.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nExclusion Criteria:\n\n* Prior CD19-directed therapy.\n* Radiation therapy within 21 days prior to day 1 of protocol therapy.\n* Central nervous system (CNS) disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Active diarrhea.\n* Clinically significant uncontrolled illness.\n* Active infection requiring antibiotics.\n* Other active malignancy.\n* Females only: Pregnant.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":204,"type":20},[401],"EARLY_PHASE1","This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.",[26,33],"2026-02-02",{"date":406,"type":44},"2026-02-04",{"date":408,"type":44},"2023-07-20",{"date":410,"type":20},"2027-01-04",{"name":233,"class":51},{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":21,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":437},"100487938","phase-2-testing-drug-treatments-after-car-t-cell-therapy-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100487938","NCT05633615","Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma","Inclusion Criteria:\n\n* STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal large B-cell lymphoma (PMBCL)\n* STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma\n* STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter \\> 1.5 cm)\n* STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS) lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must be asymptomatic from their CNS disease\n* STEP 1: REGISTRATION: Participants must be registered for step 1 after they have signed institutional consent for CAR T-cell leukapheresis but prior to the start of lymphodepleting (LD) chemotherapy for commercial CAR T-cell product\n* STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct.\n\n  * Participants must qualify for commercially approved CD19 CAR T-cell therapy per FDA package insert.\n  * If the CAR T-cell product does not meet parameters to be given as an FDA approved product (i.e. does not meet specification criteria mandated by FDA and is infused under an expanded access protocol \\[EAP\\] or single participant investigational new drug \\[IND\\]) the participant will be taken off of study and no longer be eligible for step 2 randomization\n* STEP 1: REGISTRATION: Participants are permitted to receive or have received 'bridging therapy' after CAR T-cell leukapheresis. However, participants must not receive polatuzumab vedotin, and\u002For mosunetuzumab as part of bridging therapy.\n\n  * Bridging therapy is defined as lymphoma directed therapy administered between leukapheresis and the start of LD chemotherapy. This includes cytotoxic chemotherapy (e.g.: bendamustine and rituximab \\[BR\\], rituximab, gemcitabine and oxaliplatin \\[R-gem\u002Fox\\]), radiation, corticosteroids, as well as novel therapies such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.: lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab, tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.\n  * If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they will ineligible to continue on step 1 registration portion of the study and be ineligible for step 2 randomization\n* STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days prior to the start of LD chemotherapy.\n\n  * All pre-CAR T-cell therapy disease must be assessed and documented on the baseline\u002Fpre-registration tumor assessment form.\n  * If receiving bridging therapy, participants must have a PET-CT scan upon completion of all planned bridging therapy. If the PET-CT scan after completion of bridging therapy is consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.\n  * Participants are permitted to receive corticosteroids after leukapheresis without the need to repeat a PET-CT scan. If steroids are used, they must be planned to stop no later than 3 days before CAR -T cell infusion.\n  * If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 1: REGISTRATION: Participants that have previously been treated with polatuzumab vedotin or mosunetuzumab prior to CAR T-cell leukapheresis for either indolent or aggressive NHL are eligible as long as the participant did not have refractory disease or progression\u002Frelapse within 6 months of the last infusion with either agent\n* STEP 1: REGISTRATION: Participants must be planning to receive CAR T-cell infusion no earlier than 2 days and no later than 14 days after completion of the last day of lymphodepleting chemotherapy. Any participant receiving CAR T-cell infusion outside of this window will be ineligible for step 2 randomization\n* STEP 1: REGISTRATION: LD chemotherapy prior to CAR T-cell infusion must be planned to start within 60 days after step 1 registration\n* STEP 1: REGISTRATION: Participants must be \\>= 18 years of age at the time of registration\n* STEP 1: REGISTRATION: Participants must have Zubrod performance score (PS) of 0, 1, or 2\n* STEP 1: REGISTRATION: Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (within 14 days prior to registration)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 1: REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN (within 14 days prior to registration)\n* STEP 1: REGISTRATION: Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 14 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* STEP 1: REGISTRATION: Participants must have an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 60 days prior to registration with a cardiac ejection fraction \\>= 40%.\n\n  * Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.\n  * Participants must not have documented myocardial infarction and percutaneous coronary intervention (PCI) within 6 months prior to registration or myocardial infarction without PCI within 3 months of registration, or unstable angina\n* STEP 1: REGISTRATION: Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 1: REGISTRATION: Participants with hepatitis B virus infection must have undetectable viral load within 14 days prior to registration, be on suppressive therapy and have no evidence of hepatitis B virus (HBV) related hepatic damage\n* STEP 1: REGISTRATION: Participants with hepatitis C infection must have eradication therapy completed, have no evidence of hepatitis C infection (HCV) related damage and have undetectable viral load within 14 days prior to registration\n* STEP 1: REGISTRATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* STEP 1: REGISTRATION: Participants must be offered the opportunity to participate in banking for planned translational medicine and future research. With participant consent, any residuals from the mandatory tissue submission will also be banked for future research.\n\n  * Note: Streck tubes must be ordered in advance. Please allow 5-7 days for shipment of the collection kits\n* STEP 1: REGISTRATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n    * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for step 1 registration\n* STEP 2: RANDOMIZATION: Participant's CAR T-cell product must have met specification parameters to be given as an FDA approved commercial product\n* STEP 2: RANDOMIZATION: Participants must have a PET-CT scan between days 25-40 after CAR T-cell infusion and determined to have a response consistent with stable disease or partial remission by central review compared to most recent pre-LD chemo\u002FCAR T-cell PET-CT scan.\n\n  * Note: Patients with delayed enrollment \\> 21 days after 'day +30' PET-CT scan will necessitate a repeat PET-CT scan if concerning signs or symptoms of lymphoma progression develop.\n  * Note: If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 2: RANDOMIZATION: Eligible participants must be randomized no later than 60 days after CAR -T infusion\n* STEP 2: RANDOMIZATION: Participants must have started LD chemotherapy within 60 days of signing consent for step 1 registration\n* STEP 2: RANDOMIZATION: Participants must have S2114 CAR T-cell therapy form submitted to Southwest Oncology Group (SWOG) prior to step 2 randomization\n* STEP 2: RANDOMIZATION: Participants must have had a PET-CT scan upon completion of all planned bridging therapy if received, with the exception of up to 7 days of corticosteroids. If the PET-CT scan after completion of bridging therapy was consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.\n\n  * If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization\n* STEP 2: RANDOMIZATION: Participants must have Zubrod PS of 0, 1, or 2\n* STEP 2: RANDOMIZATION: Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^3\u002FuL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 75 x 10\\^3\u002FuL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\\u003C 2 x institutional ULN (within 7 days prior to step 2 randomization)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 2: RANDOMIZATION: AST and ALT =\\\u003C 3 x institutional ULN (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 7 days prior to step 2 randomization. Estimated creatinine clearance is based on actual body weight (within 7 days prior to step 2 randomization)\n* STEP 2: RANDOMIZATION: Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 2: RANDOMIZATION: Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 2 randomization and on suppressive therapy\n* STEP 2: RANDOMIZATION: Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 2 randomization\n* STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be continuing to receive anti-retroviral therapy and have an undetectable viral load test within 14 days prior to step 2 randomization\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have documented disease progression while on Arm 4 (observation) on this protocol. The follow-up tumor assessment form documenting disease progression must be submitted to SWOG prior to step 3 crossover registration\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must be registered within 28 days of the date of progression\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have imaging that clearly demonstrates progression compared to day +30 PET-CT scan\n\n  * Note: These scans should be performed as standard of care and only performed between scheduled response assessments required for study if symptoms arise that are concerning for progression\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have Zubrod PS of 0, 1, or 2\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): ANC \\>= 1.0 x 10\\^3\u002FuL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Platelets \\>= 75 x 10\\^3\u002FuL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Total bilirubin =\\\u003C 2 x institutional ULN (within 14 days prior to step 3 crossover registration)\n\n  * Unless due to Gilbert's disease or lymphomatous involvement of liver\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): AST and ALT =\\\u003C 3 x institutional ULN\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Creatinine clearance \\>= 40 mL\u002Fmin, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within days prior to step 3 crossover registration. Estimated creatinine clearance is based on actual body weight (within 14 days prior to step 3 crossover registration)\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with peripheral neuropathy must have \\\u003C grade 2\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration and on suppressive therapy\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration\n* STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with known human immunodefici",{"count":420,"type":20},396,[23],"This phase II trial tests whether mosunetuzumab and\u002For polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and\u002For polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.",[424,425,426,26,33,427,428],"Diffuse Large B-Cell Lymphoma","Grade 3b Follicular Lymphoma","Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Transformed Follic Lymph to Diff Large B-Cell Lymphoma","Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma","2026-01-30",{"date":404,"type":44},{"date":432,"type":44},"2023-06-12",{"date":434,"type":20},"2030-06-30",{"name":436,"class":343},"SWOG Cancer Research Network",87,{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":21,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":52},"100600505","phase-1-st-067-in-combination-with-cd19-directed-car-t-cell-therapy-liso-cel-in-relapsedrefractory-large-b-cell-lymphoma-100600505","NCT07098364","ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1\u002F2 Open-Label Study Evaluating the Safety and Efficacy of ST-067 in Combination With CD19-Directed CAR T-Cell Therapy in Patients With Relapsed\u002FRefractory (R\u002FR) Large B-Cell Lymphoma (LBCL)","Inclusion Criteria:\n\n* Male or female \\>= 18 years of age at the time of consent\n* Patients with LBCL (including diffuse large B-cell lymphoma \\[DLBCL\\] not otherwise specified \\[including DLBCL arising from indolent lymphoma\\], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 lines of systemic therapy and an Food and Drug Administration (FDA)-approved indication for treatment with liso-cel\n* Fluorodeoxyglucose (FDG)-avid disease on PET imaging before lymphodepletion or pathology evidence of active disease\n* Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology\n* Karnofsky performance status \\>= 60%\n* Adequate bone marrow function for lymphodepletion chemotherapy defined as: absolute neutrophil count (ANC) \\>= 1000 cells\u002Fmm\\^3, platelets \\>= 50,000 cells\u002Fmm\\^3, and hemoglobin \\>= 8 g\u002FdL, unless the cytopenias are due to bone marrow involvement by lymphoma in the opinion of the principal investigator (PI)\n* Calculated creatinine clearance (Cockcroft\u002FGault) \\> 30 mL\u002Fmin\u002F1.73 m\\^2\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (or \\\u003C 5 x ULN for subjects with lymphomatous infiltration of the liver) and total bilirubin =\\\u003C 2 (or \\\u003C 3.0 for subjects with Gilbert's syndrome, lymphomatous infiltration of the liver, or hemolysis)\n* Adequate pulmonary function based on pulmonary function testing (PFT), defined as forced expiratory volume in 1 second (FEV1) and FEV1\u002Fforced vital capacity (FVC) ratio of \\>= 60% of predicted value and diffusing capacity of the lung for carbon monoxide (DLCO; corrected) \\>= 40% of predicted value\n* Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\>= 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA)\n* Women of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use suitable methods of contraception for at least 30 days after the last dose of study therapy (ST-067)\n* Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method for at least 90 days after the last dose of study therapy (ST-067)\n* Ability to understand and provide informed consent\n* Able and willing to comply with study visit schedule and procedures, including tumor biopsy where feasible and with acceptable risk\n\nExclusion Criteria:\n\n* Planned use of out-of-specification liso-cel product\n* History of another malignancy. The following are exceptions to this criterion:\n\n  * Adequately treated basal cell or squamous cell carcinoma of the skin.\n  * In situ prostate, ductal breast carcinoma breast, and cervical carcinoma.\n  * Adequately treated papillary, noninvasive bladder cancer.\n  * Other adequately treated stage 1 or 2 cancers currently in complete remission.\n  * Any other cancer that has been in remission for \\>= 2 years\n* Planned use of therapeutic doses of corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent) or other systemic immunosuppression within 7 days prior to leukapheresis or within 72 hours prior to liso-cel infusion. Topical and\u002For inhaled steroids are permitted\n* Prior treatment with any CD19 CAR T-cell therapy\n* For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and\u002For systemic GVHD therapy within 30 days prior to planned leukapheresis\n* Known active hepatitis B (detectable hepatitis B deoxyribonucleic acid \\[DNA\\]) or hepatitis C (detectable hepatitis C ribonucleic acid \\[RNA\\])\n* Known human immunodeficiency virus (HIV) infection\n* Pregnant or breastfeeding women\n* Prior treatment with any IL-1 or IL-18 agonist and\u002For biosimilar agents, or an investigational agent within 4 weeks or 5 half-lives, whichever is shorter, prior to start of lymphodepletion\n* Active autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis, Crohn's disease\\], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea, autoimmune vasculitis, systemic lupus erythematosus, Wegener syndrome \\[granulomatosis with polyangiitis\\], myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) requiring immunosuppressive therapy. The following are exceptions to this criterion:\n\n  * Vitiligo.\n  * Alopecia.\n  * Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Type 1 diabetes mellitus.\n  * Psoriasis not requiring systemic treatment.\n  * Conditions considered to be low risk of serious deterioration by the PI\n* History of any one of the following cardiovascular conditions within the past 6 months, unless clearance by a cardiologist is obtained: class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, or unstable angina. History of other clinically significant cardiac disease that, in the opinion of the PI or designee, is a contraindication to study treatment is also excluded\n* Significant electrocardiogram (ECG) abnormalities, including unstable cardiac arrhythmia requiring medication, second-degree atrioventricular (AV) block type II, third-degree AV block, \\>= grade 2 bradycardia, or QT interval corrected using Fridericia's formula \\> 500 ms irrespective of gender\n* History or presence of clinically relevant central nervous system (CNS) pathology, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis that in the opinion of the PI is a contraindication to study treatment.\n\n  * Patients with active parenchymal CNS involvement by malignancy will be excluded. Patients with prior or current secondary leptomeningeal CNS disease are eligible. CNS disease prophylaxis must be stopped at least 1 week prior to liso-cel infusion\n* History of solid organ transplantation\n* Active, serious, and uncontrolled infection(s)",{"count":446,"type":20},33,[63,23],"This phase I\u002FII trial tests the safety, side effects, and best dose\u002Fregimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed\u002Frefractory LBCL.",[26,27,138,450,451,139,33,34,141,452,453,142],"Recurrent High-Grade B-Cell Lymphoma","Recurrent Indolent B-Cell Non-Hodgkin Lymphoma","Refractory High-Grade B-Cell Lymphoma","Refractory Indolent B-Cell Non-Hodgkin Lymphoma","2026-01-13",{"date":456,"type":44},"2026-01-14",{"date":458,"type":44},"2025-12-27",{"date":460,"type":20},"2043-10-04",{"name":462,"class":51},"Fred Hutchinson Cancer Center",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":21,"phases":472,"briefSummary":473,"conditions":474,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":485},"100507666","phase-2-study-adding-drugs-to-usual-treatment-for-large-b-cell-lymphoma-that-returned-or-did-not-respond-to-treatment-100507666","NCT05890352","Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment","Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Participants must have:\n\n  * Histologically confirmed relapsed\u002Frefractory LBCL as outlined by the World Health Organization (WHO) guidelines\n  * Follicular lymphoma, grade 3B\n  * Transformed lymphoma\n  * High grade B-cell lymphoma with or without MYC, BCL2 and\u002For BCL6 rearrangements\n* Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter \\>= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be documented on the Baseline Tumor Assessment Form.\n* Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.\n* Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma\n* Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy\n* Steroid use for the control of non-Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to Cycle 1, Day 1\n* Participant must be \\>= 18 years old\n* Participant must have Zubrod Performance Status of 0-3\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Absolute neutrophil count (ANC) \\>= 0.75 x 10\\^3\u002FuL\n* Platelets \\>= 75 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Platelets \\>= 50 x 10\\^3\u002FuL\n* Aspartate aminotransferase (AST) =\\\u003C 3 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =\\\u003C 3 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.\n\n  * Participants with lymphomatous involvement of the liver must have AST =\\\u003C 5 x IULN, ALT =\\\u003C 5 x IULN\n* Total bilirubin =\\\u003C 1.5 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.\n\n  * Participants with lymphomatous involvement of the liver must have total bilirubin =\\\u003C 5 x IULN\n* Participants must have a calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Participants must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy\n* Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration\n* Participants must be able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants who can complete the FACT-Lym and PRO-CTCAE forms in English or Spanish must agree to participate in the patient-reported outcome study\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations.\n\nExclusion Criteria:\n\n* Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not effective to sufficiently penetrate the blood brain barrier\n* Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing. Testing is not required for eligibility determination\n* Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)\u002FT-cell acute leukemia (T-ALL). Testing is not required for eligibility determination\n* Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible\n* Participants must not have received prior treatment with tafasitamab and\u002For lenalidomide\n* Participants must not have had prior BTK inhibitor or tazemetostat\n* Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib\n* Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration\n\n  * Notes: Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing and must follow the guidelines according to the lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program. The effects of tazemetostat, zanubrutinib, lenalidomide and tafasitamab, and the combination of these drugs have not been studied on the developing human fetus are the effects are unknown. Individuals who are of reproductive potential must have agreed to use a highly effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential\". In addition to routine contraceptive methods, \"acceptable contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":471,"type":20},227,[23],"This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.",[425,475,476,26,33,477],"High Grade B-Cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","Transformed Non-Hodgkin Lymphoma","2025-10-16",{"date":480,"type":44},"2025-10-20",{"date":482,"type":44},"2023-09-26",{"date":124,"type":20},{"name":436,"class":343},104,{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":497,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":52},"100519718","phase-1-phase-i-clinical-trial-of-rc19d2-cell-injection-in-the-treatment-of-diffuse-large-b-cell-lymphoma-100519718","NCT06047197","Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma","Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Understand and voluntarily sign the informed consent form;\n* Age ≥ 18 years old at the time of screening, regardless of gender;\n* Patients with diffuse large B-cell lymphoma who have been diagnosed as CD19 positive by histopathology and\u002For cytology, but have failed standard treatment in the early stage, and currently lack effective treatment methods for recurrent or refractory CD19 positive.\n* The regulations for the past treatment status of research participants are as follows (meeting at least one of them): 1.At least after sufficient second-line treatment (CD20 positive individuals must have already used sufficient amounts of CD20 targeted drugs and anthracycline drugs), recurrence, no remission, or progression; In the first two lines of treatment, if the optimal therapeutic effect is SD, then the line of treatment must have completed 2 cycles;2.Recurrence, unrelieved, or progression after autologous hematopoietic stem cell transplantation;\n* According to the 2023 NCCN Lymphoma Treatment Guidelines and the 4th edition of the WHO Lymphatic Tissue Tumor Classification in 2016, the following types were included in this trial:Diffuse large B-cell lymphoma (DLBCL) non-specific (DLBCL-NOS)；Transforming follicular lymphoma (tFL)；High grade B-cell lymphoma (HGBL) with MYC, BCL2, and\u002For BCL6 rearrangement；High grade B-cell lymphoma, non-specific (HGBL-NOS)；Primary mediastinal large B-cell lymphoma (PMBL)；Grade 3b follicular lymphoma (FL3b);\n* Expected survival time ≥ 12 weeks;\n* There are measurable target lesions in imaging: the length and diameter of lesions in lymph nodes ≥ 15mm, or extranodal lesions\\>10mm (according to Lugano2014 standard); Lesions that have received radiotherapy in the past are considered measurable only when there is clear progress after completing radiotherapy;\n* During screening, laboratory inspections must meet the following requirements:Neutrophil count ≥ 1.0 × 10\\^9\u002FL;Lymphocyte count ≥ 0.3 × 10\\^9\u002FL; Hemoglobin ≥ 70 g\u002FL;Platelets ≥ 50 × 10\\^9\u002FL;Total serum bilirubin ≤ 2.0 × Upper limit of normal value (ULN);Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;Creatinine\\\u003C1.5 × ULN and endogenous creatinine clearance rate ≥ 60 mL\u002Fmin (creatinine clearance rate Cockcroft Fault method: male creatinine clearance rate=\\[(140 age) × Weight (kg)\\]\u002F\\[0.818 × Creatinine（ μ Mol\u002FL)\\]; Female creatinine clearance rate=\\[(140 age) × Body weight (kg) × 0.85\\]\u002F\\[0.818 × Creatinine（ μ Mol\u002FL)\\].\n* The lung function is good, and the blood oxygen saturation of the fingertip pulse under non oxygen inhalation is ≥ 92%;\n* The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0 or 1;\n* Head MRI shows no central nervous system lymphoma;\n* Cardiac ultrasound shows left ventricular ejection fraction ≥ 50%; No clinically significant abnormal electrocardiogram findings; No clinically significant pericardial or pleural effusion;\n* Adequate venous access (for single collection) and no other contraindications for blood cell separation;\n* The screening period blood pregnancy test for female participants of childbearing age must be negative\n\nExclusion Criteria:\n\n* Individuals with a history of allergies to any component in cellular products;\n* Individuals with a history of allogeneic hematopoietic stem cell transplantation;\n* Individuals with a history of organ transplantation;\n* hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the HBV-DNA quantity is higher than the upper limit of normal value; Hepatitis C virus antibody (HCV Ab) is positive and HCV RNA quantification is higher than the upper limit of normal values; Positive for human immunodeficiency virus antibody (HIV-Ab); Positive anti Treponema pallidum antibody (TP Ab); Cytomegalovirus DNA quantification is higher than the upper limit of normal values; EB virus DNA quantification is higher than the upper limit of normal values;\n* CNS diseases that have clinical significance in the past or screening, such as epilepsy, epileptic seizures, paralysis, aphasia, cerebral vascular ischemia\u002Fbleeding, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, mental illness, etc;\n* Patients with active primary or secondary central nervous system (CNS) lymphoma (patients with CNS disease symptoms must undergo lumbar puncture examination to rule out CNS lymphoma).\n* Those who have previously received other genetically modified T cell therapies, or other CAR-T therapies, or any other targeted therapy against CD19;\n* Having severe genetic or autoimmune diseases (such as systemic lupus erythematosus);\n* Screening for thromboembolic events within the first 6 months (such as myocardial infarction, pulmonary infarction, deep vein thrombosis, and other systemic thrombotic diseases);\n* Screening for malignant tumors other than those indicated in this study within the first 5 years, except for tumors in situ (such as cervical cancer, bladder, breast cancer) or non melanoma skin cancer;\n* Active or uncontrollable infections that require systemic treatment;\n* Within 9 months prior to PBMC collection, received treatment with Bendamustine、Alenzumab, Fludarabine,and Cladribine;;\n* Within 4 weeks prior to PBMC collection, patients received naloxamine, calcineurin inhibitors, chemotherapy drugs (methotrexate, cyclophosphamide, ifosfamide, benzoate nitrogen mustard or mefalam,), mycophenolate, thalidomide, immunosuppressive antibodies such as anti TNF, anti IL6, or anti IL6R therapy, tumor radiotherapy, or drugs that can bind to FKBP 12 protein (such as rapamycin, tacrolimus, everolimus, etc.);\n* Long acting cell growth factors (such as polyethylene glycol recombinant human granulocyte stimulating factor PEG-rhG-CSF) were used within 3 weeks prior to PBMC collection;\n* Received granulocyte macrophage colony stimulating factor (GM-CSF) treatment within 2 weeks prior to PBMC collection;\n* Individuals who have received short-term cell growth factors (such as recombinant human granulocyte colony-stimulating factor, recombinant human thrombopoietin, etc.), hematopoiesis agonists\u002Fstimulators (such as haitrapopa ethanolamine tablets), CD20 monoclonal antibodies, and corticosteroids within 7 days prior to PBMC collection (excluding those who have received inhaled, local steroid therapy, and physiological replacement therapy for adrenal insufficiency);\n* Received platelet transfusion within 7 days before the screening period;\n* Pregnant or lactating women, or men or women with fertility potential, refuse to use contraception during the trial period and at the end of the trial (2 years after RC19D2 cell reinfusion);\n* Patients who have participated in other drug clinical trials within 4 weeks prior to PBMC collection (new drug clinical trials, registered studies, clinical studies initiated by researchers, etc.);\n* The researcher believes that this clinical trial is not suitable (such as poor compliance, drug abuse, etc.);\n* Those who have received live or attenuated vaccines within 3 months prior to PBMC collection, or are expected to need to receive such vaccines during this trial.",{"count":19,"type":20},[63],"This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma",[26,168],[498,499,500,501],"CD19","CAR-T","RC19D2","DLBCL","2024-08-25",{"date":504,"type":44},"2024-08-27",{"date":506,"type":44},"2023-09-05",{"date":508,"type":20},"2026-12-05",{"name":510,"class":511},"Beijing Yongtai Ruike Biotechnology Company Ltd","INDUSTRY",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":21,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100433168","phase-2-dpx-survivac-and-pembrolizumab-with-and-without-intermittent-low-dose-cyclophosphamide-in-subjects-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100433168","NCT04920617","DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (VITALIZE)","VITALIZE","Key Inclusion Criteria:\n\n* Adults ≥ 18 years of age who are willing and able to provide written informed consent\n* Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.\n* Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.\n* Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).\n* Subjects must have failed or be ineligible for ASCT or CAR-T\n* Have at least one bi-dimensionally measurable lesion per Lugano (2014)\n* Willing to provide pre-treatment and on-treatment tumor biopsy tissue.\n* Meet protocol-specified laboratory requirements\n* Life expectancy \\> 3 months.\n\nKey Exclusion Criteria:\n\n* Primary CNS lymphoma or active secondary CNS involvement and\u002For lymphomatous meningitis\n* Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter\n* Radiotherapy within 14 days of day 0\n* Autologous stem cell transplant (ASCT) within ˂100 days prior to D0\n* Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0\n* Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years\n* Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)\n* Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment",{"count":521,"type":20},102,[23],"This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.",[525,168],"Relapsed Diffuse Large B-cell Lymphoma",[527,528,501,529,530,531],"Immunotherapy","T cell activation","Anti-PD-1","CAR-T ineligible","ASCT ineligible","2023-04-05",{"date":534,"type":44},"2023-04-07",{"date":536,"type":44},"2021-06-18",{"date":538,"type":20},"2025-04",{"name":540,"class":511},"ImmunoVaccine Technologies, Inc. (IMV Inc.)",50,{"id":543,"slug":544,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":16,"minAge":550,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":21,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":4},"100428215","phase-1-a-phase-iii-study-of-diffuse-large-b-cell-lymphoma-100428215","NCT04856137","A Phase I\u002FII Study of Diffuse Large B-cell Lymphoma","A Phase I\u002FII Study of Relapse\u002FRefractory Diffuse Large B-cell Lymphoma","DLBL","Inclusion Criteria:\n\n1. Patients with relapsed\u002Frefractory CD20+ diffuse large B-cell lymphoma.\n2. Age greater than 20 years and younger than 75 years old.\n3. Measurable disease\n4. Patients must have an ECOG performance status of less than or equal to 2.\n5. Patients must have recovered from toxic effects of all prior therapy before entering onto study.\n6. A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.\n7. More than 4 weeks since prior radiotherapy is required.\n8. Adequate bone marrow function\n9. Adequate renal function with calculated glomerular filtration rate \\> 15 mL\u002Fmin\n10. Patients must have adequate liver function\n11. All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.\n\nExclusion Criteria:\n\n1. Patients who have prior treatment with ruxolitinib or taxane for DLBCL.\n2. Pregnant or breast-feeding females.\n3. Active or uncontrolled infection.\n4. Life expectancy \\\u003C 6 months\n5. Patients with brain or leptomeningeal metastases.\n6. Known hypersensitivity to ruxolitinib or paclitaxel\n7. Grade III peripheral neuropathy secondary to prior to therapy\n8. Second malignancy, except indolent cancers not on active anti-cancer therapy.","20 Years","75 Years",{"count":553,"type":20},74,[63,23],"For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.",[168],"2021-04-19",{"date":559,"type":44},"2021-04-23",{"date":561,"type":20},"2021-05-01",{"date":563,"type":20},"2028-12-31",{"name":565,"class":51},"National Health Research Institutes, Taiwan"]