[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-transformed-follicular-lymphoma-to-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-transformed-follicular-lymphoma-to-diffuse-large-b-cell-lymphoma":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,73],{"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":63,"conditions":64,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"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":61,"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":67,"type":44},"2026-06-16",{"date":69,"type":44},"2025-08-07",{"date":71,"type":20},"2029-01",{"name":50,"class":51},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"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":81,"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.",[26,85,32,33,86,39],"Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","2026-03-03",{"date":89,"type":44},"2026-03-05",{"date":91,"type":44},"2026-02-11",{"date":93,"type":20},"2029-01-23",{"name":95,"class":51},"City of Hope Medical Center"]