[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"grade-3b-follicular-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:grade-3b-follicular-lymphoma":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,81],{"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":36,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100518113","phase-1-cd79b-19-car-t-cells-in-non-hodgkin-lymphoma-100518113",false,"NCT06026319","CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma","A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign informed consent form(s)\n* ≥18 years of age at the time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* Diagnosis of histologically or cytologically confirmed relapsed\u002Frefractory (R\u002FR) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive\u002Fbulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and\u002For in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):\n\n  1. Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  2. Marginal Zone Lymphoma (MZL) nodal of extranodal:\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  3. Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).\n\n     1. R\u002FR disease after 2 or more prior lines of therapy OR\n     2. Relapsed following autologous SCT, OR\n     3. Ineligible for autologous SCT.\n  4. Mantle cell lymphoma\n\n     1. R\u002FR disease as defined by disease progression after last regimen (including autologous SCT) OR\n     2. Refractory disease as defined as failure to achieve a CR to last regimen.\n     3. Prior therapy must include:\n\n        * Anthracycline or bendamustine-containing chemotherapy AND\n        * Anti-CD20 monoclonal antibody therapy AND\n        * BTKi therapy (progression does not have to be documented on BTKi).\n* Subjects must have measurable disease according to appropriate disease specific criteria.\n* Adequate absolute lymphocyte count (ALC \\> 100 cells\u002Ful) within one week of apheresis.\n* Adequate bone marrow function defined by absolute neutrophil count (ANC) \\>1000 cells\u002Fmm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \\>50,000 mm3.\n* Left ventricular ejection fraction \\> 40%\n* Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C 1.5 × ULN.\n* Adequate renal function defined by creatinine clearance \\>60 ml\u002Fmin using the Cockcroft-Gault formula.\n* The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. 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. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nInclusion Criteria for treatment (Initiating Lymphodepletion\u002FCell Infusion):\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy\n* Oxygen saturation \\>92% on room air while awake\n* No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.\n\nInfusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that these issues resolve in that time frame.\n\nThe above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).\n\nExclusion Criteria for Leukapheresis for Parts A and B:\n\n* Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.\n* Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).\n* No bispecific T cell engagers within 6 months of leukapheresis.\n* No bendamustime within 6 months of leukapheresis.\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.\n* Ongoing systemic immunosuppression for acute and\u002For chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.\n* Presence of active CNS disease\n* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and\u002For recent significant traumatic injury.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.\n* Subjects with history of a new pulmonary embolism (PE) \u002Fdeep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent 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 CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.\n\nAdditional Exclusion Criteria for Leukapheresis for Part B, Arm B.2:\n\n* Prior CD19-directed cellular therapy.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed\u002Frefractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells.\n\nThis research study involves the study drugs:\n\n* CD79b-19 CAR T cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[26,27,28,29,30,31,32,33,34,35],"Non-hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Diffuse Large B Cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Grade 3b Follicular Lymphoma","Mantle Cell Lymphoma",[37],"Relapsed\u002FRefractory B-cell Lymphoma","RECRUITING","2026-03-13",{"date":41,"type":42},"2026-03-16","ACTUAL",{"date":44,"type":42},"2023-10-26",{"date":46,"type":20},"2028-01-01",{"name":48,"class":49},"Marcela V. Maus, M.D.,Ph.D.","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"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":59,"type":20},396,[61],"PHASE2","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.",[64,34,65,66,67,68,69],"Diffuse Large B-Cell Lymphoma","Primary Mediastinal (Thymic) Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse 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":72,"type":42},"2026-02-02",{"date":74,"type":42},"2023-06-12",{"date":76,"type":20},"2030-06-30",{"name":78,"class":79},"SWOG Cancer Research Network","NETWORK",87,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"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":89,"type":20},227,[61],"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.",[34,93,94,66,67,95],"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":98,"type":42},"2025-10-20",{"date":100,"type":42},"2023-09-26",{"date":102,"type":20},"2029-01",{"name":78,"class":79},104]