[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transformed-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transformed-non-hodgkin-lymphoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,86,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100400218","phase-1-autologous-stem-cell-transplant-followed-by-polatuzumab-vedotin-in-patients-with-b-cell-non-hodgkin-and-hodgkin-lymphoma-100400218",false,"NCT04491370","Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Inclusion Criteria:\n\n* Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.\n* Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse\u002Fprogression having attained a CR, PR, or stable disease post reinduction therapy.\n* Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.\n* Life Expectancy Patients must have a life expectancy of \\> 6 weeks.\n* Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).\n  2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n* Organ Function Requirements\n\nAdequate Renal Function Defined As:\n\n* Creatinine clearance or radioisotope GFR \\> 60 mL\u002Fmin\u002F1.73 m2 or\n* A serum creatinine based on age\u002Fgender as follows:\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n* 12 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n* 16 years 1.7 1.4\n\n  * Adequate Liver Function Defined As:\n\n    * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and\n    * SGOT (AST) or SGPT (ALT) \\\u003C 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma.\n  * Adequate Cardiac Function Defined As:\n\n    * Shortening fraction of \\> 27% by echocardiogram, or\n    * Ejection fraction of \\> 50% by radionuclide angiogram.\n  * Adequate Pulmonary Function Defined As:\n\n    • Normal respiratory rate for age and a pulse oximetry \\> 94% on room air unless due to underlying malignancy.\n  * Peripheral Blood Stem Cell Collection\n\n    • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent.\n\nExclusion Criteria:\n\n* Patient may not have had a prior stem cell transplant\n* Patients must not have active CNS lymphoma\n* Other concurrent investigational agents for treatment of B-cell lymphoma\n* Pregnancy and\u002For active Breast Feeding\n* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.\n* Patient must not have an uncontrolled infection.\n* Patient must not have ≥ Grade 3 neuropathy.","ALL","12 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.",[28,29,30,31,32,33,34,35,36],"B-cell Lymphoma","Burkitt Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma","Transformed Non-Hodgkin Lymphoma","Richter Syndrome","Hodgkin Lymphoma","RECRUITING","2026-04-10",{"date":40,"type":41},"2026-04-15","ACTUAL",{"date":43,"type":41},"2021-08-01",{"date":45,"type":21},"2027-08-15",{"name":47,"class":48},"New York Medical College","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100553435","phase-2-a-study-of-wztl-002-car-t-cells-for-adults-with-relapsed-large-b-cell-lymphoma-100553435","NCT06486051","A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma","A Phase 2 Trial to Evaluate the Efficacy and Safety of WZTL-002 in Patients With Relapsed or Refractory Large B-cell Lymphoma (ENABLE-2)","ENABLE-2","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive) at the time of informed consent\n2. Signed written informed consent for this trial\n3. Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours\n\n   * Large B-cell lymphomas of the following histological subtypes:\n\n     * Diffuse LBCL, not otherwise specified\n     * Diffuse large B-cell lymphoma\u002Fhigh grade B-cell lymphoma with MYC and BCL2 rearrangements\n     * Large B-cell lymphoma with IRF4 rearrangement\n     * High grade B-cell lymphoma with 11q aberrations\n     * High grade B-cell lymphoma, not otherwise specified\n     * Primary mediastinal large B-cell lymphoma\n     * Follicular large B-cell lymphoma\n     * EBV-positive diffuse large B-cell lymphoma, not otherwise specified\n     * Diffuse large B-cell lymphoma associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n   * Large B-cell lymphoma of one of the above subtypes that has transformed from follicular or marginal zone lymphoma\n4. Received adequate first-line lymphoma therapy for the qualifying histology (as defined in inclusion criterion 3 above), comprising at least 2 cycles of a standard combination regimen incorporating an anthracycline and an anti-CD20 monoclonal antibody\n5. Relapsed or refractory disease meeting one of the following criteria:\n\n   * Relapsed or refractory within 12 months of first-line chemoimmunotherapy, defined as:\n\n     * Progressive disease following ≥ 2 cycles of chemoimmunotherapy, or\n     * Stable disease following ≥ 4 cycles of chemoimmunotherapy, or\n     * Partial response following ≥ 6 cycles of chemoimmunotherapy, or\n     * Complete response followed by biopsy-proven relapse within 12 months of completing first-line chemoimmunotherapy.\n   * Relapsed or refractory following second-line chemoimmunotherapy, defined as:\n\n     * Lack of complete response to, or relapse following, autologous stem cell transplantation as part of second-line therapy for the qualifying histology, or\n     * Inability to proceed to autologous stem cell transplantation due to lack of response to 2 cycles of second-line chemoimmunotherapy incorporating both a platinum agent and an anti-CD20 monoclonal antibody\n6. Positron emission tomography (PET) positive disease according to the Lugano 2014 criteria\n7. Available tumour tissue (comprising a tissue block or at least 6 unstained slides) for central histological review\n8. Lymphoma-related life expectancy at least 12 weeks, and life expectancy related to conditions other than lymphoma at least 12 months\n9. ECOG performance status of 0 or 1\n10. Adequate haematologic function, defined by:\n\n    * Neutrophils ≥ 1.0 × 10\\^9\u002FL, and Platelets ≥ 75 × 10\\^9\u002FL, and\n    * Lymphocytes ≥ 0.3 × 10\\^9\u002FL\n11. Adequate renal function, defined by estimated creatinine clearance (eCrCl) or glomerular filtration rate (eGFR) \\>\u002F= 45mL\u002Fmin using the Cockroft Gault estimation, CKD-EPI equation or as assessed by direct measurement.\n12. Adequate hepatic function, defined by serum bilirubin \\\u003C 2.5 × upper limit of normal (ULN) (unless attributable to Gilbert's syndrome) and alanine transaminase and aspartate aminotransferase \\\u003C 3 × ULN.\n13. Adequate lung function, defined as ≤ Grade 1 dyspnoea according to NCI CTCAE v5.0, and oxygen saturation (sO2) ≥ 92% on room air.\n14. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram or multigated acquisition (MUGA), performed within 28 days of commencing screening.\n15. For female participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, or\n    * Are not of reproductive potential defined as either,\n\n      * being amenorrhoeic for at least 12 consecutive months with FSH 30 ≥ IU\u002FL, or\n      * previously undergone a sterilisation procedure\n16. For male participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If undertaking sexual activity with a female partner of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, and\n    * Agree not to donate sperm for conception, or to provide gametes for in vitro fertilisation for at least 12 months after administration of WZTL-002\n17. Participant agrees not to donate blood components at any time after receiving WZTL-002\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) involvement by lymphoma. In patients with a history of CNS disease or a clinical suspicion of current CNS disease, lumbar puncture and MRI brain must be performed within 30 days of enrolment to exclude current CNS involvement.\n2. Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease, or cerebellar disease\n3. B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours:\n\n   * Richter transformation of chronic lymphocytic leukaemia\n   * T-cell\u002Fhistiocyte rich LBCL\n   * Primary LBCL of immune-privileged sites\n   * Fluid overload associated LBCL\n   * Fibrin-associated LBCL\n   * Plasmablastic lymphoma\n   * Mediastinal grey zone lymphoma\n   * Intravascular LBCL\n   * ALK-positive large B-cell lymphoma\n   * Lymphomatoid granulomatosis\n   * Burkitt lymphoma\n   * Primary effusion lymphoma\n   * KSHV\u002FHHV8-positive diffuse large B-cell lymphoma\n4. Patient has received 3 or more prior lines of therapy for LBCL, where 1 line of therapy is defined as 1 or more cycles of a combination chemoimmunotherapy with or without pre-planned consolidation therapy (radiotherapy, autologous stem cell transplant or immunotherapy)\n5. Requirement for urgent lymphoma therapy due to tumour-related symptoms, or due to imminent risk of blood vessel, airway, urinary tract, gastrointestinal tract, nerve or spinal cord compression\n6. Active autoimmune disease requiring current systemic immunosuppression\n7. Active sarcoidosis\n8. Prior solid organ transplantation or prior allogeneic stem cell transplantation (allo-SCT)\n9. Peripheral blood CD3+ T cells \\\u003C 150\u002FμL (0.15 x10\\^9\u002FL) as assessed by lymphocyte subset analysis\n10. History of active malignancy other than B-cell malignancy within 2 years prior to enrolment, with the exception of: adequately treated in situ carcinoma of the cervix; adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin; other localised malignancy surgically resected (or radically treated with another treatment modality) with curative intent\n11. Prior treatment with:\n\n    * gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy, or\n    * purine analogue (including bendamustine) or alemtuzumab within 6 months of enrolment, or\n    * bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment, or\n    * cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment.\n12. Pregnant or lactating female\n13. Known sensitivity to immunoglobulin or to components of the IP\n14. Current or prior HIV infection\n15. Vaccination with a live virus within the 4 weeks of enrolment\n16. Inadequately-controlled systemic infection\n17. Serologic status reflecting active viral hepatitis B or active hepatitis 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) DNA is undetectable (or is \\\u003C 20 IU\u002FmL), and if they are willing to receive appropriate antiviral prophylaxis.\n    * Presence of active Hepatitis C infection as determined by Hepatitis C virus (HCV) RNA detected by PCR or nucleic acid testing (NAT). Patients with presence of HCV antibody, are eligible if HCV RNA is undetectable.\n18. Current New York Heart Association (NYHA) class 2 or higher cardiac symptoms, or myocardial infarction, unstable angina or other clinically significant cardiac disease within the past 6 months\n19. Significant concomitant illnesses which would in the Investigators opinion make the patient an unsuitable candidate for the trial\n20. Patients who have diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP\n21. Patient does not provide consent to enrol to an International Cellular Therapy Registry","18 Years","75 Years",{"count":61,"type":21},60,[25],"The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are:\n\n* What is the likelihood of complete response of the lymphoma after WZTL-002 treatment?\n* What is the risk of altered brain function (neurotoxicity) after WZTL-002?\n\nAll eligible participants will receive WZTL-002; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies.\n\nParticipants will:\n\n* Have a procedure to gather white blood cells\n* Receive chemotherapy to prepare for the CAR T-cells\n* Receive WZTL-002 CAR T-cells through a vein\n* Be monitored closely for the first 14 days for certain side effects\n* Have scans 28 days and 3, 6, 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked",[65,66,67,34],"Large B-cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[69,70,71,72,73,74,75],"Chimeric Antigen Receptor Therapy","CD19 Antigen","Toll-Like Receptor 2","CD28 Antigen","Relapsed non-Hodgkin Lymphoma","Refractory non-Hodgkin Lymphoma","Adoptive Cellular Immunotherapy","2026-02-27",{"date":78,"type":41},"2026-03-03",{"date":80,"type":41},"2024-07-12",{"date":82,"type":21},"2028-06-30",{"name":84,"class":48},"Malaghan Institute of Medical Research",3,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":49},"100472496","phase-1-genetically-modified-t-cells-cmv-specific-cd19-car-t-cells-plus-a-vaccine-cmv-mva-triplex-following-stem-cell-transplantation-for-the-treatment-of-intermediate-or-high-grade-b-cell-non-hodgkin-lymphoma-100472496","NCT05432635","Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma","Pilot\u002FFeasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)","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 PI approval\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed\n* Age \\>= 18 years\n* Karnofsky performance status (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma \\[DLBCL\\], mantle cell lymphoma \\[MCL\\], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy\n\n  * Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy\n* No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines\n* Patient must be CMV seropositive\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0\n* Aspartate aminotransferase (AST) \\\u003C 2.5 x upper limits of normal (ULN)\n* Alanine aminotransferase (ALT) \\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 2.5 x ULN or estimated creatinine clearance of \\>= 40 mL\u002Fmin per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Absolute neutrophil count \\>= 1000\u002FuL (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Platelet count \\>= 50,000\u002FuL (\\>= 30,000\u002FuL if bone marrow plasma cells are =\\> 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)\n* Left ventricular ejection fraction \\>= 45 percent within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% without requiring supplemental oxygen\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\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 6 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* Prior autologous\u002Fallogeneic stem cell transplant\n* Growth factors within 14 days of enrollment\n* Platelet transfusions within 7 days of enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\\u003C 5 mg \u002Fday, or equivalent doses of other corticosteroids) is allowed\n* Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed\n* Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy\n* Any standard contraindications to myeloablative HSCT per standard of care practices at COH\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\\\u003C 5 white blood cells \\[WBC\\] \u002F mm\\^3 and no blasts in cerebrospinal fluid \\[CSF\\]) will be eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years.\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Immunodeficiency virus (human immunodeficiency virus \\[HIV\\]) positive\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Procedures (including compliance issues related to feasibility\u002Flogistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study\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":94,"type":21},15,[24],"This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are 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 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. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.",[98,99,32,100,101,102,103,34],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Recurrent B-Cell Non-Hodgkin Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Mantle Cell Lymphoma","Recurrent Transformed Non-Hodgkin Lymphoma","2026-02-20",{"date":106,"type":41},"2026-02-23",{"date":108,"type":41},"2023-08-01",{"date":110,"type":21},"2028-12-30",{"name":112,"class":48},"City of Hope Medical Center",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"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":121,"type":21},227,[25],"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.",[125,126,127,101,128,34],"Grade 3b Follicular Lymphoma","High Grade B-Cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","Refractory Diffuse Large B-Cell Lymphoma","2025-10-16",{"date":131,"type":41},"2025-10-20",{"date":133,"type":41},"2023-09-26",{"date":135,"type":21},"2029-01",{"name":137,"class":138},"SWOG Cancer Research Network","NETWORK",104]