[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"burkitt-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:burkitt-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,48,106,134,158,187,224,256,279,309,337,364,393,414,443,465,506,531,560,585,613,645,676,706],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100469178","phase-1-pomalidomide-and-dose-adjusted-epoch---rituximab-for-hiv-associated-lymphomas-100469178",false,"NCT05389423","Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","Phase I Trial of Pomalidomide and Dose-Adjusted EPOCH +\u002F- Rituximab for HIV-Associated Lymphomas","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed B-cell NHL confirmed by the Laboratory of Pathology (LP), NCI, with one or more of the following features:\n\n  * Leptomeningeal\u002FCSF involvement\n  * High-risk for CNS relapse per CNS-IPI (score 4-6)\n  * Plasmablastic histology\n  * Gamma herpesvirus positive tumor\n  * Presence of KS\n* Measurable or evaluable lymphoma.\n* Positive HIV1\u002F2 serology.\n* Individuals may not have received prior curative-intent chemotherapy for lymphoma. Individuals who have received prior treatment as a bridge to curative-intent therapy will be considered per Protocol Chair discretion if \\>= 2 weeks since administration. Steroids given for any reason or rituximab given for multicentric Castleman disease may be given any time prior to treatment start.\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) \\\u003C=4\n* Individuals of childbearing potential (IOCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 2 weeks prior to and again within 1 day before starting the study drugs and must either commit to continued abstinence from penetrative vaginal intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before the participant starts taking pomalidomide and for 12 months after the last dose of combined chemotherapy.\n* Individuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to six (6) months after the last dose of the study drug(s). We also will recommend individuals able to father a child with IOCBP partners to ask the partners to be on an effective birth control (hormonal, intrauterine device (IUD), surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n* All individuals must agree to be registered into the mandatory POMALYST REMS(R)TM program and be willing and able to comply with the requirements of the POMALYST REMS(R)TM program.\n* Able to take aspirin 81mg orally daily or another substitute thromboprophylaxis.\n* Adequate organ and marrow function as defined below unless abnormalities are attributed to lymphoma or HIV as determined by investigator:\n\n  * absolute neutrophil count \\>=1,000\u002FmcL\n  * platelets \\>=75,000\u002FmcL\n  * total bilirubin \\\u003C=1.5 X institutional upper limit of normal (individuals with history of Gilbert disease are eligible if total bilirubin \\\u003C= 5 mg\u002FdL with \\\u003C80% unconjugated bilirubin)\n  * aspartate aminotransferase (AST) \u002F alanine transaminase (ALT) \\\u003C=3 X institutional upper limit of normal\n  * creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal.\n* Hepatitis B virus (HBV) infection must be on suppressive antiviral therapy.\n* Willingness to take and adhere to ART (individuals are not required to be on any specific regimen of ART).\n* Individuals must understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Individuals may not receive investigational agents on other clinical trials.\n* Requirement of any of the agents listed as prohibited thearapies.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide or other agents used in study.\n* Parenchymal brain involvement with lymphoma.\n* Ejection fraction less than 40% by echocardiography (ECHO)\n* CTCAEv5.0 Grade 3-4 neuropathy\n* History of malignant tumors other than KS or KSHV-associated multicentric Castleman Disease, (MCD), unless:\n\n  * In complete remission for \\>= 1 year from the time response was first documented; or,\n  * Completely resected basal cell carcinoma; or,\n  * In situ squamous cell carcinoma of the cervix or anus; or,\n  * Prior or concurrent malignancy has a natural history or treatment which does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen per Protocol Chair discretion.\n* Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.\n* Symptomatic congestive heart failure\n* Unstable angina pectoris, symptomatic cardiac arrhythmia, or cardiac arrhythmia requiring medical treatment.\n* Uncontrolled intercurrent illness or participants considered to be of poor medical health due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection (excluding lymphoma or HIV) as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies.\n* Pregnant or nursing individuals (if lactating, must agree not to nurse while taking pomalidomide).","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Background:\n\nNon-Hodgkin lymphoma (NHL) is the most common cancer among people living with HIV in the United States. People with HIV are up to 17 times more likely to get NHL than people who do not have HIV. The disease may also be different in these two groups. More study is needed for treating\n\npeople with both HIV and NHL.\n\nObjective:\n\nTo test a study drug (pomalidomide) in combination with chemotherapy with or without another drug (rituximab) in people with HIV-associated NHL.\n\nEligibility:\n\nAdults aged 18 years or older diagnosed with HIV-associated B-cell NHL with high-risk features.\n\nDesign:\n\nIndividuals will undergo screening. They will have a physical exam. They will have blood and urine tests and tests of heart function. They may have imaging scans. Researchers will review tissue samples of individual s tumors. In some cases, a new biopsy may be needed.\n\nIndividuals will receive up to 6 cycles of treatment.\n\nThe first cycle is 26 days: Individuals will take pomalidomide by mouth for 10 days. After 5 days they will start receiving chemotherapy drugs through a tube attached to a needle placed in a vein (IV). Some participants will receive rituximab on day 5. All individuals will receive a second set of IV drugs that will last for 4 days (96 hours). They will receive another IV drug after the previous treatment is complete.\n\nThe remaining cycles are each 21 days. Individuals will take pomalidomide by mouth for the first 10 days. Other chemotherapy treatments will also be repeated starting on day 1 of each cycle.\n\nScreening tests will be repeated at study visits.\n\nFollow-up visits will continue for 4 years....",[26,27,28,29,30],"Diffuse Large Cell Lymphoma","Non-Hodgkin Lymphoma","Burkitt Lymphoma","Plasmablastic Lymphoma","B-Cell Neoplasm",[27,32,29,33,34],"Epstein Barr Virus","Chemotherapy","Immune Modulatory","RECRUITING","2026-06-27",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2023-06-27",{"date":43,"type":20},"2032-06-01",{"name":45,"class":46},"National Cancer Institute (NCI)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":47},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":57,"type":20},300,[59],"PHASE2","This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,28,82,83,84,85,86,87,88],"Acute Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[90,16,91,92,93,94,95],"AML","MDS","NHL","CLL","CML","SLL","2026-06-23",{"date":98,"type":39},"2026-06-25",{"date":100,"type":39},"2018-03-30",{"date":102,"type":20},"2028-06-10",{"name":104,"class":105},"Masonic Cancer Center, University of Minnesota","OTHER",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":47},"100404393","phase-1-anti-cd19-chimeric-antigen-receptor-t-cells-for-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-100404393","NCT04545762","Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma","THE DOSE ESCALATION COHORT IS CLOSED TO FURTHER ENROLLMENT.\n\nInclusion Criteria:\n\nDose expansion Cohorts:\n\nCohort B (Burkitt):\n\n1. Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma\n\n   * Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline.\n   * No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells.\n2. Participants must have measurable disease as defined below:\n\n   * Participants with Burkitt Lymphoma must have Positron Emission Tomography (PET)-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\"\n\nCohort M\u002FW (Marginal\u002FWaldenström):\n\n1. Participants must have a diagnosis of relapsed or refractory Marginal Zone Lymphoma (MZL), or Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenström Macroglobulinemia (WM):\n\n   o Participants with indolent lymphomas (nodal or extranodal marginal zone lymphoma, and lymphoplasmacytic lymphoma) must have relapsed after or have been refractory to ≥ 2 prior lines of multi-agent chemoimmunotherapy including prior exposure to an anti-CD20 antibody and an alkylating agent.\n2. Participants must have measurable disease as defined below:\n\n   o Participants with Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia: must either have PET-positive disease according to \"Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\" or serum monoclonal immunoglobulin M (IgM) paraprotein \\> 0.5 g\u002FdL.\n3. Participants with indolent lymphoma (Marginal Zone Lymphoma or Lymphoplasmacytic Lymphoma\u002FWaldenström Macroglobulinemia) must have symptomatic disease or steady progression necessitating systemic treatment per investigator discretion.\n\nIn addition, all participants must meet the following criteria:\n\n1. CD19-positive by either immunohistochemistry or flow cytometry analysis on any biopsy. If prior anti-CD19 therapy has been administered, CD19-positivity has to be re-established on the most recent biopsy.\n2. Age ≥18 years at the time of consent.\n3. Absolute lymphocyte count \\> 100\u002FUL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2.\n5. Adequate organ function, defined as:\n\n   1. Adequate bone marrow function for apheresis and lymphodepleting chemotherapy\n   2. Hemoglobin \\>8 gm\u002Fdl (transfusions allowed)\n   3. Platelets \\>50,000\u002FuL (transfusions allowed)\n   4. Absolute Neutrophil Count (ANC) \\> 500\u002FuL\n   5. alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\\u003C 3 x institutional upper limit of normal (ULN) and Total bilirubin \\\u003C 1.5 mg\u002Fdl x institutional ULN, except with Gilbert's syndrome\n   6. Serum Creatinine \\\u003C 2 x the institutional ULN\n   7. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) \\> 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) within 3 months of screening. Repeat testing may occur at Investigator's discretion.\n6. Adequate vascular access for leukapheresis procedure (either peripheral line or surgically placed line).\n7. Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-CD19 CAR-T cells.\n8. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method.\n9. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 weeks of planned CAR-T cell infusion.\n2. Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol.\n3. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast).\n4. Human immunodeficiency virus (HIV) seropositivity.\n5. Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded.)\n6. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test.\n8. Participants with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n9. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n10. Body weight \\\u003C40 kilograms(kg).\n\nEligibility for Infusion of Investigational Product:\n\nParticipants will undergo an evaluation of eligibility on day 1 prior to infusion of anti-CD19 CAR-T cell product. This eligibility criterion will include the inclusion and exclusion criteria required for enrollment with the following exceptions and additions:\n\n1. No significant laboratory abnormalities. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition.\n2. ECOG performance status \\\u003C 2\n3. No evidence of uncontrolled intercurrent illness including, but not limited to ongoing or active infection, inflammatory response, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations.\n4. No new neurologic symptoms suggestive of an active central nervous system condition, or uncontrolled CNS involvement by lymphoma.\n5. No corticosteroid use within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy).",{"count":114,"type":20},36,[23],"This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).",[118,28,119,76,77,120,121,74,122,27],"Refractory Non-Hodgkin Lymphoma","Mantle Cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Diffuse Large B Cell Lymphoma","Transformed Lymphoma",[124],"CAR-T Therapy","2026-06-17",{"date":127,"type":39},"2026-06-22",{"date":129,"type":39},"2020-09-11",{"date":131,"type":20},"2026-10-31",{"name":133,"class":105},"C. Babis Andreadis",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":47},"100302934","phase-1-venetoclax-ibrutinib-prednisone-obinutuzumab-and-revlimid-vipor-in-relapsedrefractory-b-cell-lymphoma-100302934","NCT03223610","Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","Phase 1b\u002F2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows:\n\nPhase1b\n\n* Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n\n  -Indolent B-cell lymphoma:\n* CLL\u002FSLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL\u002FSLL compared to other non-Hodgkin lymphomas.\n\n  * NOTE: Patients with known active CNS lymphoma are not eligible.\n\nPhase 2\n\n* Relapsed and\u002For refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n* Relapsed and\u002For refractory Follicular lymphoma (FL)\n* Relapsed and\u002For refractory and untreated Mantle cell lymphoma (MCL)\n* Relapsed and\u002For refractory disease on at least 1 prior treatment regimen, as follows:\n\n  * Aggressive B-cell lymphoma:relapsed after and\u002For refractory to at least 1 prior anthracycline-containing regimen\n  * Indolent B-cell lymphoma: relapsed after and\u002For refractory to at least 1 prior anti-CD20 antibody-containing regimen.\n* NOTE: Patients with untreated and relapsed and\u002For refractory MCL will be included in the phase 2 MCL expansion.\n* Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and\u002For imaging (measurable lymph nodes or masses on CT or MRI and\u002For evaluable FDG-avid lesions on PET).\n* NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.\n* Age greater than or equal to 18 years\n* NOTE: Because no dosing or adverse event data are currently available on the use of venetoclax in combination with ibrutinib, obinutuzumab, prednisone and Revlimid(R) in patients \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status less than or equal to 2\n* Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma:\n\n  * absolute neutrophil count\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 1,000\u002FmcL\n  * hemoglobin\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 8 g\u002FdL\n  * platelets greater than or equal to 75,000\u002FmcL\n  * INR: less than or equal to 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation\n  * PTT\u002FaPTT: less than or equal to 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant\n  * Total Bilirubin: less than or equal to 1.5 X institutional ULN (or less than or equal to 3 X institutional ULN for patients with documented Gilberts syndrome)\n  * AST(SGOT)\u002FALT(SGPT): less than or equal to 2.5 X institutional ULN\n  * Serum Creatinine: less than or equal to 2.0mg\u002FdL OR\n  * Creatinine Clearance: greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 2 mg\u002FdL\n\nCr Cl will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \\[IBM\\] instead of mass):\n\n(140 - Age) x IBM (kg) x \\[0.85 if female\\]\u002F 72 x serum creatinine (mg\u002FdL)\n\n\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n* Immune-modulating drugs (IMiDs) including Revlimid(R) are known to be teratogenic and potential embryo-fetal harm can be seen with use of venetoclax and ibrutinib. The effects of obinutuzumab on the developing human fetus is unknown. For these reasons, women of child-bearing potential and men must agree to use adequate contraception as described below.\n* For women of childbearing potential:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year as outlined below.\n  * Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days and again within 24 hours prior to prescribing Revlimid(R) for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS(TM) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid(R). FCBP must also agree to ongoing pregnancy testing.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1% per year as noted below. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Contraception Requirements:\n\nPre-Treatment\u002FDuring Treatment:\n\n--All Drugs- Women- begins 28 days prior to treatment; Men- Begins on day 1\n\nPost-Treatment:\n\n* Venetoclax- Women- 90 days; Men 90 days\n* Ibrutinib- Women- 3 months; Men- 3 months\n* Obinutuzumab- Women- 18 months; Men- 6 months\n* Revlimid- Women-28 days; Men- 28 days\n\n  * All study participants must be registered into the mandatory Revlimid REMS(TM) program and be willing and able to comply with the requirements of Revlimid REMS(TM). NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program\n  * Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\n\n* Patients who are actively receiving any other investigational agents.\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\n* Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).\n\n  * Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin.\n  * Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\n* Strong CYP3A inhibitors\n* Strong CYP3A inducers\n\nNOTE: Moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible.\n\nUncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Uncontrolled and\u002For symptomatic thyroid disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1;\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with HBV or HCV:\n\n  --Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Patients with occult or prior HBV infection (defined as positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) with negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo HBV DNA testing during treatment and in surveillance for at least 12 months after completion of study therapy.\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women, or women who intend to become pregnant during the study, are excluded from this study because Revlimid(R) has known teratogenic effects and venetoclax, ibrutinib and obinutuzumab are agents 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 these agents, breastfeeding should be discontinued if the mother is treated on study.\n* HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions with venetoclax, ibrutinib and Revlimid(R) and combination antiretroviral therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Evidence of active tumor lysis syndrome based on laboratory assessment\n* History of recent major surgery within 6 weeks prior to the start of Cycle 1, Day 1 other than for diagnosis\n* History of other active malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be eligible. Individuals in documented remission without treatment for greater than or equal to 2 years prior to enrollment may be included at the discretion of the investigator.\n* Known allergy to both xanthine oxidase inhibitors and rasburicase; or, known hypersensitivity to any of the study drugs","120 Years",{"count":143,"type":20},155,[23,59],"Background:\n\nB-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).\n\nObjective:\n\nTo study the safety of ViPOR for people with B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, urine, and heart tests\n* Tissue sample from previous procedure\n* Imaging scans\n* Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.\n\nParticipants will have a bone marrow aspiration before treatment.\n\nParticipants may have tumor samples taken.\n\nParticipants will get ViPOR in 21-day cycles. For up to 6 cycles:\n\n* Participants will get one drug by IV on days 1 and 2.\n* Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.\n\nParticipants will keep a drug diary.\n\nParticipants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.\n\nParticipants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.",[65,27,147,28],"Diffuse Large B-Cell Lymphoma",[149,150],"Monoclonal Antibody","Dose-Finding","2026-06-16",{"date":125,"type":39},{"date":154,"type":39},"2018-02-09",{"date":156,"type":20},"2027-12-01",{"name":45,"class":46},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":186},"100546451","phase-1-substudy-01a-zilovertamab-vedotin-in-pediatric-and-young-adult-participants-with-hematologic-malignancies-or-solid-tumors-mk-9999-01alightbeam-u01-100546451","NCT06395103","Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A\u002FLIGHTBEAM-U01)","LIGHTBEAM-U01 Substudy 01A: A Phase 1\u002F2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL\u002FBurkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.\n* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.\n\nExclusion Criteria:\n\n* History of solid organ transplant.\n* Clinically significant (ie, active) cardiovascular disease.\n* Known history of liver cirrhosis.\n* Ongoing Grade \\>1 peripheral neuropathy.\n* Demyelinating form of Charcot-Marie-Tooth disease.\n* Diagnosed with Down syndrome.\n* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.\n* History of human immunodeficiency virus (HIV) infection.\n* Contraindication or hypersensitivity to any of the study intervention components.\n* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.\n* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).\n* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and\u002For cytoreductive therapy with steroids\u002Fhydroxyurea.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Known additional malignancy that is progressing or has required active treatment within the past 1 year.\n* Active infection requiring systemic therapy.\n* Known history of Hepatitis B or known active Hepatitis C virus infection.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.","6 Months","25 Years",{"count":168,"type":20},90,[23,59],"Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)\u002FBurkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.",[172,173,28,174,175],"B-cell Acute Lymphoblastic Leukemia","Diffuse Large B-cell Lymphoma","Neuroblastoma","Ewing Sarcoma","2026-06-04",{"date":178,"type":39},"2026-06-08",{"date":180,"type":39},"2024-08-16",{"date":182,"type":20},"2029-03-31",{"name":184,"class":185},"Merck Sharp & Dohme LLC","INDUSTRY",70,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":199,"conditions":200,"keywords":212,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":221,"locationsCount":223},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has 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 venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":197,"type":20},30,"OBSERVATIONAL","The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[201,202,65,203,16,204,90,66,94,205,206,207,121,76,28,208,209,210,211],"Hematologic Malignancy","Leukemia","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[213,214,215],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":176,"type":39},{"date":219,"type":39},"2023-11-15",{"date":156,"type":20},{"name":222,"class":105},"Children's Hospital Medical Center, Cincinnati",5,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":231,"sex":16,"minAge":165,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":47},"100377523","phase-2-donor-stem-cell-transplant-with-treosulfan-fludarabine-and-total-body-irradiation-for-the-treatment-of-hematological-malignancies-100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n* DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.",true,{"count":233,"type":20},60,[59],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[62,64,63,237,238,28,239,240,207,81,77,119,241,242,79,243,244,245,246],"Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","2026-05-27",{"date":249,"type":39},"2026-05-29",{"date":251,"type":39},"2021-01-25",{"date":253,"type":20},"2029-03-12",{"name":255,"class":105},"Fred Hutchinson Cancer Center",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100598300","phase-1-testing-the-safety-of-anti-cancer-drug-cx-5461-pidnarulex-in-treating-lymphoma-with-specific-changes-in-the-myc-gene-100598300","NCT07069699","Testing the Safety of Anti-Cancer Drug, CX-5461 (Pidnarulex), in Treating Lymphoma With Specific Changes in the MYC Gene","Phase 1b\u002F2 Trial of Pidnarulex in MYC Aberrant Lymphoma","Inclusion Criteria:\n\n* Patients must have one of the following subtypes of aggressive B-cell non-Hodgkin lymphomas: double-expressor lymphoma (DEL), high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangement, or Burkitt lymphoma (BL). Eligible patients must have received at least two prior lines of treatment for diffuse large B-cell lymphoma (DLBCL) or at least one prior line of therapy for Burkitt Lymphoma and must have disease for which no standard curative or palliative treatment options exist or remain effective (Quin et al., 2016)\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of CX-5461 (Pidnarulex) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). ECOG 3 is allowed if directly related to lymphoma per treating provider\n* Absolute neutrophil count ≥ 1,000\u002FmcL\n* Platelets ≥ 50,000\u002FmcL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)\n\n  * Patients with documented Gilbert's syndrome may be included if total bilirubin is ≤ 3 × ULN and direct bilirubin is within normal limits\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F, calculated by multiplying the estimated (e)GFR (mL\u002Fmin\u002F1.73 m\\^2) by the individual's body surface area (BSA, calculated using an accepted formula) and dividing by 1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with cytopenia related to abnormal bone marrow function in the setting of bone marrow involvement with lymphoma or post chimeric antigen receptor (CAR) T-cell are allowed to enroll if deemed safe by treating provider\n* Patients without clinical evidence of central nervous system (CNS) lymphoma\n* The effects of CX-5461 (Pidnarulex) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 6 months after the last dose of study drug. 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. Women should not breastfeed while taking CX-5461 (Pidnarulex) and for 6 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (Pidnarulex) administration. Women of childbearing age should not donate egg(s) and men should not donate sperm for the duration of study participation and 6 months after completion of the last dose CX-5461 (Pidnarulex)\n* Willingness to provide blood and biopsy samples for research purposes\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients must have recovered from clinically significant adverse events (AEs) of their most recent cancer immunotherapy to grade 1 or less (with the exception for alopecia or lymphopenia)\n* Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (Pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. For medications or substances not listed, or in cases of uncertainty, the Principal Investigator may consult with a medical expert or a pharmacologist to make an informed decision regarding eligibility\n* Patients with a baseline corrected QT (QTc) interval \\> 480 msec\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (Pidnarulex)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CX-5461 (Pidnarulex) is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CX-5461 (Pidnarulex), breastfeeding should be discontinued if the mother is treated with CX-5461 (Pidnarulex)",{"count":264,"type":20},50,[23,59],"This phase Ib\u002FII trial tests the safety, side effects, best dose and how well giving CX-5461 works for the treatment of patients with B-cell non-Hodgkin lymphoma. CX-5461 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CX-5461 may be safe, tolerable and\u002For effective in treating patients with B-cell non-Hodgkin lymphoma.",[28,268,269],"Double-Expressor Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","2026-05-12",{"date":272,"type":39},"2026-05-13",{"date":274,"type":20},"2026-10-13",{"date":276,"type":20},"2030-01-31",{"name":45,"class":46},4,{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":194,"maxAge":166,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":47},"100500332","mcw-alphabeta-t-cell-and-b-cell-depletion-with-targeted-atg-dosing-100500332","NCT05794880","MCW Alpha\u002FBeta T-Cell and B-Cell Depletion With Targeted ATG Dosing","Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha\u002FBeta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641","Inclusion Criteria:\n\n1. Patient age \\\u003C 25 years. Both genders and all races eligible.\n2. Disease eligibility\n\n   * Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)\n   * Myelodysplasia\n   * Acute lymphoblastic leukemia - Disease status: MRD negative\n   * Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase\n   * Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative\n   * Lymphoblastic lymphoma - Disease status: in remission\n   * Burkitt's lymphoma\u002Fleukemia - Disease status: in remission\n   * Lymphoma after relapse - Disease status: in remission\n   * Other malignant hematologic diseases in remission (to be approved by PI)\n3. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)\n4. Evaluation of organ status as per MCW BMT SOP\n5. Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.\n6. Signed consent by parent\u002Fguardian or able to give consent if ≥18 years.\n7. Negative pregnancy test for patients capable of childbearing potential\n8. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \\[IUD\\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.\n\nDonor Eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. Infectious disease testing\n3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.\n4. Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.\n5. Unrelated Donor:\n\n   a. HLA typing of at least 10 alleles is required. Donor must be matched at 9\u002F10 or 10\u002F10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis\n6. Haploidentical Related Donor:\n\n   1. Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5\u002F10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8\u002F10) encouraged.\n\nExclusion Criteria:\n\n1. Patients who do not meet disease, organ, or infectious criteria.\n2. No suitable donor\n3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants\n4. Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.\n5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease\n6. Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.",{"count":287,"type":20},40,[289],"NA","This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha\u002Fbeta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival",[202,292,70,293,294,295,296,297,81,28,298,299,300],"Acute Myeloid Leukemia in Remission","Acute Lymphoblastic Leukemia in Remission","Chronic Myelogenous Leukemia - Chronic Phase","Chronic Myelogenous Leukemia, Accelerated Phase","Chronic Myelogenous Leukemia With Crisis of Blast Cells","Biphenotypic Acute Leukemia","Burkitt Leukemia","Lymphoma After Relapse","Other Malignant Hematologic Diseases in Remission","2026-05-08",{"date":272,"type":39},{"date":304,"type":39},"2023-05-01",{"date":306,"type":20},"2032-05",{"name":308,"class":105},"Medical College of Wisconsin",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":47},"100600428","phase-2-epcoritamab-with-dose-adjusted-etoposide-cyclophosphamide-vincristine-doxorubicin-prednisone-and-rituximab-epoch-r-for-the-treatment-of-aggressive-b-cell-non-hodgkin-lymphoma-100600428","NCT07097363","Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma","A Pilot Study of Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Untreated aggressive large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to R-CHOP and in the opinion of the investigator would be treated with dose adjusted (DA)-EPOCH-R as standard of care. Subjects must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care. 1 prior cycle of chemoimmunotherapy may be allowed. Composite lymphomas are not excluded provided that the subject has not received prior systemic therapy for the indolent component and would receive DA-EPOCH-R as the standard of care regimen for the aggressive component. Eligible histologies based on 2016 World Health Organization (WHO) classification include:\n\n  * High grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 translocations\n  * High grade B-cell lymphoma, not otherwise specified (NOS)\n  * Diffuse large b-cell lymphoma (DLBCL) NOS\n  * Primary mediastinal B-cell lymphoma\n  * T-cell\u002Fhistiocyte-rich large-B-cell lymphoma\n  * Epstein Barr virus (EBV) + DLBCL, NOS\n  * Burkitt lymphoma\n  * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma\n* Be willing and able to provide written informed consent for the trial\n* Be ≥ 18 years of age on day of signing informed consent\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on CT or FDG-PET\n* Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS) at time of enrollment\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL except in cases of marrow infiltration by lymphoma\n* Platelets ≥ 75,000 \u002F mcL except in cases of marrow infiltration by lymphoma or hypersplenism\n* Hemoglobin ≥ 8 g\u002FdL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment\n* Measured or calculated\\* creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine clearance \\[CrCl\\]) ≥ 45 mL\u002Fmin\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin ≤ 3.0 x ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement\n* International Normalized Ratio (INR) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants or prothrombin Time (PT) ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≤ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of ≤ 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the last treatment. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of EPOCH-R, including, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (400 mg\u002Fm\\^2)\n* Prior systemic treatment for lymphoma. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response\n* Transformation from indolent lymphoma is allowed provided that the subject has not received prior systemic therapy for their lymphoma and the aggressive component meets one of the criteria listed in inclusion criterion\n* Prior organ transplantation\n* Current grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* Prior systemic therapy for indolent lymphoma\n* Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids and\u002For 1 cycle of chemoimmunotherapy in the following manner:\n\n  * Up to 30 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment). If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll. A maximum of 1 cycle of chemoimmunotherapy is allowed if needed for urgent disease stabilization if patient had staging PET\u002FCT and LVEF evaluation prior to chemoimmunotherapy; in this situation patients will receive therapy on study starting with cycle (C)1 day (D)8 epcoritamab provided the next cycle of EPOCH-R chemotherapy will not be delayed by \\> 7 days. In this situation, the date of receiving the first dose of EPOCH-R is considered C1D1 of the study treatment. Labs collected prior to C1D1, in accordance with SOC for the administration of these drugs, can be used for screening purposes\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third degree heart block, or evidence of prior myocardial infarction in the last 6 months\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1.\n\n  * If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:\n\n    * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  * Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled HIV\n\n  * Patients with known diagnosis of HIV must have undetectable viral load and be on anti-retroviral therapy\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Patients with known active central nervous system lymphoma\n* Patients needing a treatment regimen which would require use of mid-cycle high dose IV methotrexate for central nervous system (CNS) prophylaxis in the opinion of the treating provider\n* Pregnancy or lactation or intending to become pregnant during study",{"count":317,"type":20},18,[59],"This phase II trial tests the safety, best dose, and effectiveness of epcoritamab when given with etoposide, cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab (EPOCH-R) for the treatment of patients with aggressive B-cell non-Hodgkin lymphoma. Epcoritamab is a bispecific antibody that can bind to two different antigens at the same time. Epcoritamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Prednisone 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. The EPOCH-R is administrated as the standard of care treatment. This may help the immune system kill cancer cells. Giving epcoritamab with EPOCH-R may be safe, tolerable, and effective in treating patients with aggressive B-cell non-Hodgkin lymphoma.",[321,28,322,323,269,324,325,326,327],"B-Cell Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma, Not Otherwise Specified","Primary Mediastinal Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma","Transformed B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma to Diffuse Large B-Ce","2026-04-21",{"date":330,"type":39},"2026-04-23",{"date":332,"type":39},"2025-12-07",{"date":334,"type":20},"2030-05-31",{"name":336,"class":105},"University of Washington",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":16,"minAge":344,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":21,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":47},"100400218","phase-1-autologous-stem-cell-transplant-followed-by-polatuzumab-vedotin-in-patients-with-b-cell-non-hodgkin-and-hodgkin-lymphoma-100400218","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.","12 Years","70 Years",{"count":347,"type":20},20,[23,59],"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.",[351,28,121,76,119,352,353,354,207],"B-cell Lymphoma","Marginal Zone Lymphoma","Transformed Non-Hodgkin Lymphoma","Richter Syndrome","2026-04-10",{"date":357,"type":39},"2026-04-15",{"date":359,"type":39},"2021-08-01",{"date":361,"type":20},"2027-08-15",{"name":363,"class":105},"New York Medical College",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":371,"maxAge":372,"enrollmentInfo":373,"targetDuration":4,"studyType":21,"phases":375,"briefSummary":376,"conditions":377,"keywords":381,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":374,"type":20},32,[23,59],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[172,378,73,74,352,76,119,121,379,28,380,206,241],"Large B-cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[382,202,65],"CD19-positive","2026-03-24",{"date":385,"type":39},"2026-03-30",{"date":387,"type":39},"2025-05-30",{"date":389,"type":20},"2031-09",{"name":391,"class":185},"Vironexis Biotherapeutics Inc.",9,{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":400,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":413},"100395157","recommendations-for-the-treatment-of-children-with-burkitts-lymphoma-100395157","NCT04425421","Recommendations for the Treatment of Children With Burkitt's Lymphoma","GFALMB2019","Inclusion Criteria:\n\nClinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.\n\n\\-\n\nExclusion Criteria:\n\nNot a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.",{"count":401,"type":20},1000,"This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.",[28],"2026-02-27",{"date":406,"type":39},"2026-03-02",{"date":408,"type":39},"2020-11-01",{"date":410,"type":20},"2030-12-31",{"name":412,"class":105},"French Africa Pediatric Oncology Group",7,{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":47},"100515358","phase-1-lv2019-car-t-cells-in-combination-with-pirtobrutinib-for-relapsed-refractory-b-cell-malignancies-100515358","NCT05990465","LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","To facilitate rapid start of pirtobrutinib, there will be separate inclusion\u002Fexclusion for pirtobrutinib and LV20.19 CAR T-cells in addition to the general inclusion as outlined below.\n\nGeneral inclusion criteria for trial:\n\n1. Patients must be aged ≥18 years and \\\u003C81 years with relapsed or refractory B-cell non-Hodgkin Lymphoma (NHL).\n2. Diagnosis of relapsed or refractory B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, Burkitt Lymphoma and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV)+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n3. Disease specific criteria as follows:\n\n   1. DLBCL and associated subtypes (listed above)\n\n   i. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody with combination anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma or early relapse ≤6 months after one line of therapy.\n2. For relapse \\>6.00 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\nii. Relapse post-autologous transplant. iii. Relapse post-allogeneic transplant. iv. Relapse post-CAR T-cell therapy (maximum 2 patients allowed with this designation).\n\nb. Mantle Cell Lymphoma\n\ni. Must have received Rituximab or another CD 20 antibody with one chemotherapy regimen appropriate for this disease (bendamustine or cytarabine, or anthracycline based treatment) and have ONE of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line BTK inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n\n   c. Marginal Zone Lymphoma and Follicular Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody with chemotherapy regimen appropriate for the disease and have ONE of the following:\n\n\u003C!-- -->\n\n1. Relapsed disease after two lines of therapy including administration of anti-CD20 antibody.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n\n   d. Burkitt's Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody in combination with anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma.\n2. Relapse within 6 months.\n3. For relapse \\>6 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\n   i. Relapse post-autologous transplant. ii. Relapse post-allogeneic transplant.\n4. Able to provide written informed consent.\n5. Negative urine or serum pregnancy test in females of childbearing potential at screening.\n6. Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for duration of treatment and for 1 month following the last dose if study treatment.\n7. Karnofsky performance score ≥70.\n8. Expected survival \\>12 weeks.\n9. Patient has demonstrated compliance with prior therapies.\n10. Able to take oral medications.\n11. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x upper limit of normal (ULN).\n12. Patients are required to have the following washout periods prior to planned Cycle 1 Day 1 (C1D1). In addition, prior treatment-related adverse events (AEs) must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n\n    1. Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter.\n    2. immunoconjugated antibody treatment within 10 weeks prior to randomization.\n    3. broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study enrollment.\n    4. palliative limited field radiation must be completed 7 days prior to study enrollment.\n\nInclusion Criteria to START Pirtobrutinib Bridging:\n\n1. Absolute neutrophil count (ANC) ≥1000 with no G-CSF within 7 days or pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n2. Platelets≥50,000 with no transfusion within 7 days unless patient has biopsy proven bone marrow involvement.\n3. Hemoglobin ≥8g\u002FdL (≥80 g\u002FL) \\[blood transfusions are allowable to reach this goal\\].\n4. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C3 x upper limit of normal (ULN) or \\\u003C 5 x ULN with documented liver involvement; serum bilirubin \\\u003C1.5 x ULN or \\\u003C3 x ULN with documented liver involvement , or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n5. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin.\n\n   1. No IV hydration within 24 hours of eligibility.\n   2. No dialysis dependent renal failure.\n\nInclusion criteria for Pirtobrutinib Maintenance (part B)\n\n1. Recovery of neutrophils count after CAR T-cell infusion with ANC ≥1000\u002FdL without G-CSF within the last 7 days.\n2. Recovery of platelet count after CAR T-cell infusion with platelet count ≥50,000\u002FdL.\n3. Adequate hepatic function, defined as back to baseline or AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PI's discretion (e.g., Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n4. Adequate renal function, defined as creatinine clearance≥40 ml\u002Fmin.\n5. Evidence of response or stable disease (complete response\u002Fpartial response\u002Fstable disease) at day 28 after CAR T-cell therapy.\n\nInclusion Criteria for Apheresis and LV20.19 CAR T-cells:\n\n1. Active Measurable disease must be documented within 4 weeks of lymphodepletion start defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL.\n2. Absolute cluster of differentiation (CD) 3 count≥50 mm\\^3.\n3. MRI brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment.\n4. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by echocardiogram (ECHO) or MUGA) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n5. No contraindication to central line access.\n6. ANC≥1000 with no pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n7. Platelets≥50,000 with no transfusion within 72 hours unless patient has biopsy proven bone marrow involvement.\n8. Adequate hepatic function, defined as AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n9. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin. a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential or plan to become pregnant during the study or within 1 month of the last dose of study treatment and women who are current lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n2. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n   1. HBV: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded.\n   2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.\n3. Known active cytomegalovirus (CMV) infection (Unknown or negative status are eligible).\n4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n5. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n6. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n7. Refusal to participate in the long-term follow-up protocol.\n8. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture.\n\n   1. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n9. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n10. Prior allogeneic CAR T-cell therapy \\\u003C100 days from prior CAR T-cell treatment.\n11. Previous recipients of autologous CAR-T cell therapy directed at either cluster of differentiation 19 (CD19) or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec).\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry.\n12. Anti-CD20 antibody treatment within 4 weeks of cell infusion.\n13. Anti-CD19 antibody treatment within 4 weeks of cell infusion.\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells.\n15. No other oral chemotherapeutic agents or antibody directed treatment after starting pirtobrutinib other than steroids or radiation to a single site in a palliative fashion.\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias.\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002FFollicular lymphoma (FL) \u002F Marginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma\u002FRichter's.\n18. Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n19. History of stroke or intracranial hemorrhage within 6 months of randomization.\n20. Significant cardiovascular disease defined as myocardial infarction within 6 months of randomization, congestive heart failure with ejection fraction \\\u003C30%, active unstable angina, QT prolongation (QTcF)\\>470 msec on ECG.\n21. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n22. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n23. Patients who had surgery within 4 weeks prior to randomization.\n24. Patients who have received vaccination with live vaccine within 28 days prior to randomization.\n25. Patients with known hypersensitivity to any of the excipients of pirtobrutinib.\n\n    Special Criteria Regarding Fertility and Contraception\n\n    Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed at screening.\n\n    Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\n    Acceptable birth control includes a combination of two of the following methods:\n\n    • Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n\n    • Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n\n    • Intrauterine device (IUD)\n\n    • Intrauterine hormone-releasing system (IUS)\n\n    • Vasectomized partner\n\n    • Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence will be evaluated in relation to the duration of the study and to the usual lifestyles of the patient.\n\n    • Female sterilization\n\n    • Fallopian tube implants (if confirmed by hysterosalpingogram) Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of study drug.\n\n    Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months which is non-therapy induced or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.","81 Years",{"count":423,"type":20},12,[23],"This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.",[206,121,76,352,119,28],[428,429,430,431,432,433,434],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase","2026-02-19",{"date":437,"type":39},"2026-02-23",{"date":439,"type":39},"2025-02-06",{"date":441,"type":20},"2027-07",{"name":308,"class":105},{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":166,"enrollmentInfo":450,"targetDuration":4,"studyType":21,"phases":451,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":47},"100347932","cd45ra-depleted-peripheral-stem-cell-addback-for-viral-or-fungal-infections-post-tcrcd19-depleted-hsct-100347932","NCT03810196","CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted HSCT","CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Age: Patients \\\u003C25 years.\n2. First allogeneic HSCT only.\n3. Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia\n4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).\n5. Signed consent by parent\u002Fguardian or able to give consent if \\>18 years.\n\nExclusion Criteria:\n\n1. Patients who do not meet institutional disease, organ or infectious criteria\n2. No suitable donor available for mobilized peripheral stem cells\n3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.\n4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma\n5. Pregnant Participants\n\nDonor selection and eligibility\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. HLA testing\u002Fmatching\n3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection",{"count":264,"type":20},[289],"The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections. An addback of donor CD45RA (naive T cells) depleted cells may improve immune reconstitution and help decrease the risk of infections.",[62,63,454,64,455,81,28,84],"Myelodysplastic Syndromes","Mixed Lineage Leukemia","2026-02-18",{"date":458,"type":39},"2026-02-20",{"date":460,"type":39},"2019-03-01",{"date":462,"type":20},"2028-02",{"name":464,"class":105},"Children's Hospital of Philadelphia",{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":494,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":114},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":473,"type":20},98,[23],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[477,206,478,479,480,76,481,482,483,28,29,379,484,485,119,486,120,487,488,489,490,73,491,492,77,493],"Mature B-Cell Neoplasm","DLBCL","Waldenstrom Macroglobulinemia","MALT Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","DLBCL Germinal Center B-Cell Type","T-Cell\u002FHistiocyte Rich Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Duodenal-Type Follicular Lymphoma",[495,496,479],"MALT1","NF-kB","2026-02-11",{"date":499,"type":39},"2026-02-13",{"date":501,"type":39},"2023-04-10",{"date":503,"type":20},"2027-11",{"name":505,"class":185},"Schrödinger, Inc.",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":515,"conditions":516,"keywords":520,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":47},"100314599","long-term-follow-up-study-of-patients-receiving-car-t-cells-100314599","NCT03375619","Long-term Follow-up Study of Patients Receiving CAR-T Cells","Inclusion Criteria:\n\n* All participants who enrolled in a CAR-T study at Froedtert Hospital \\& the Medical College of Wisconsin.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.","80 Years",{"count":514,"type":20},500,"This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin\u002F Froedtert Hospital. The clinical trials include the following:\n\nPhase 1 Study of CAR-20\u002F19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)",[73,517,518,119,519,121,76,28,83],"Lymphomas Non-Hodgkin's B-Cell","Lymphoma, Small Lymphocytic","Central Nervous System Lymphoma",[521,522],"CAR-T Cell Therapy","chimeric antigen receptor","2025-11-06",{"date":525,"type":39},"2025-11-10",{"date":527,"type":39},"2017-12-01",{"date":529,"type":20},"2035-01-01",{"name":308,"class":105},{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":21,"phases":540,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":550,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":47},"100605881","early-phase-1-novel-bispecific-abtcr-anti-cd19cd22-t-cells-in-relapsed-or-refractory-b-cell-lymphoma-100605881","NCT07168291","Novel Bispecific AbTCR (Anti-CD19\u002FCD22)-T Cells in Relapsed or Refractory B-cell Lymphoma","The Safety and Efficacy of Novel Bispecific AbTCR (Anti-CD19\u002FCD22)-T Cells in Patients With Relapsed or Refractory B-cell Lymphoma: An Open-label, Single-arm Clinical Study","Inclusion Criteria:\n\n1. Age≥ 18 years;\n2. Pathologically diagnosed CD19+\u002FCD22+ B-cell lymphoma;\n3. Relapsed or refractory after at least two prior lines of therapy;\n4. Patient's main organs functioning well:\n\n   1. Cardiac function: Left ventricular ejection fraction ≥50%;\n   2. Liver function: ALT and AST ≤2.5 × upper limit of normal (ULN), total bilirubin ≤2 × ULN;\n   3. Renal function: Serum creatinine ≤3.0 mg\u002FdL (≤260 μmol\u002FL);\n   4. Pulmonary function: ≤CTCAE grade 1 dyspnea and Indoor oxygen saturation ≥92%;\n   5. Adequate bone marrow function as assessed by the investigator to receive lymphodepleting chemotherapy;\n5. Adequate vascular access for leukapheresis;\n6. Women of childbearing potential (all women physiologically capable of becoming pregnant) must agree to use highly effective contraception for 1 year after AbTCR (anti-CD19\u002FCD22)-T cell infusion, such as copper-containing intrauterine device, hormonal implants, or tubal ligation; male subjects with partners of childbearing potential must agree to use effective barrier contraception for 1 year after AbTCR (anti-CD19\u002FCD22)-T cell infusion;\n7. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.\n\nExclusion Criteria:\n\n1. Lymphoma involving only the central nervous system (CNS), or secondary CNS lymphoma patients judged by the investigator to be at high risk for AbTCR (anti-CD19\u002FCD22)-T cell therapy;\n2. History of other malignancies not in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with low risk of recurrence, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or PAP smear showing squamous intraepithelial lesion);\n3. Any of the following at screening:\n\n   1. Positive hepatitis B surface antigen (HBsAg) (regardless of hepatitis B virus DNA copy number);\n   2. Positive hepatitis B core antibody (HBcAb) with increased hepatitis B virus DNA copy number;\n   3. Hepatitis C, human immunodeficiency virus (HIV), or syphilis infection;\n4. Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 3 months prior to signing informed consent;\n5. Ongoing anticoagulant therapy for deep vein thrombosis (DVT) or pulmonary embolism (PE) within 3 months prior to signing informed consent;\n6. Uncontrolled systemic fungal, bacterial, viral, or other infection;\n7. Acute or chronic graft-versus-host disease (GvHD);\n8. History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart disease;\n9. History of or current clinically significant CNS disease at screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness;\n10. Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to starting lymphodepleting chemotherapy;\n11. Use of any of the following drugs or treatments within the specified timeframes prior to leukapheresis:\n\n    1. Alemtuzumab within 6 months prior to leukapheresis;\n    2. Cladribine within 3 months prior to leukapheresis;\n    3. Fludarabine within 3 months prior to leukapheresis;\n    4. Anti-CD20 monoclonal antibody within 7 days prior to leukapheresis;\n    5. Venetoclax within 4 days prior to leukapheresis;\n    6. Idelalisib within 2 days prior to leukapheresis;\n    7. Lenalidomide within 1 day prior to leukapheresis;\n    8. Therapeutic doses of corticosteroids (defined as prednisone or equivalent \\>20 mg\u002Fday) within 7 days prior to leukapheresis; physiological replacement, topical, and inhaled steroids are permitted;\n    9. Non-lymphocytotoxic chemotherapy within 1 week prior to leukapheresis. Oral chemotherapy drugs are allowed if at least 3 half-lives have passed prior to leukapheresis;\n    10. Lymphocytotoxic chemotherapy (e.g., cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan) within 2 weeks prior to leukapheresis;\n    11. Investigational drugs within 4 weeks prior to leukapheresis. However, subjects who had no response or disease progression during experimental treatment and for whom at least 3 half-lives have passed since the last dose prior to leukapheresis are allowed;\n    12. GvHD therapy (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL6, or anti-IL6R) within 4 weeks prior to leukapheresis and AbTCR (anti-CD19\u002FCD22)-T cell infusion;\n    13. Donor lymphocyte infusion (DLI) within 6 weeks prior to AbTCR (anti-CD19\u002FCD22)-T cell administration;\n    14. Radiotherapy within 6 weeks prior to leukapheresis, including large bone marrow areas such as the sternum or pelvis. Patients with progressive disease at irradiated sites or PET-positive lesions at non-irradiated sites are eligible. Radiotherapy to a single site is allowed within 2 weeks prior to leukapheresis if there are PET-positive lesions at other non-irradiated sites;\n    15. If prior immunotherapy such as anti-PD1 or anti-PD-L1 was used, at least 5 half-lives must have passed between the last dose and AbTCR (anti-CD19\u002FCD22)-T cell infusion;\n12. Prior allogeneic hematopoietic stem cell transplantation;\n13. Other conditions considered inappropriate by the researcher.",{"count":539,"type":20},3,[541],"EARLY_PHASE1","This is an open-lable, single arm, non-randomized study to evaluate the primary safety and efficacy of the novel bispecific AbTCR (anti-CD19\u002FCD22)-T cells in patients with relapsed or refractory B-cell lymphoma",[544,545,28],"Diffuse Large B Cell Lymphoma (DLBCL)","Follicular Lymphoma ( FL)",[547,548,549],"AbTCR-T","CD19\u002FCD22","B-cell lymphoma","NOT_YET_RECRUITING","2025-09-11",{"date":553,"type":39},"2025-09-17",{"date":555,"type":20},"2025-12-31",{"date":557,"type":20},"2028-12-31",{"name":559,"class":105},"First Affiliated Hospital Xi'an Jiaotong University",{"id":561,"slug":562,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":11,"sex":16,"minAge":568,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":47},"100239288","phase-2-obinutuzumab-and-ice-chemotherapy-in-refractoryrecurrent-cd20-mature-nhl-100239288","NCT02393157","Obinutuzumab and ICE Chemotherapy in Refractory\u002FRecurrent CD20+ Mature NHL","Chemoimmunotherapy With Obinutuzumab, Ifosfamide, Carboplatin and Etoposide (O-ICE) in Children, Adolescents and Young Adults With Recurrent Refractory CD20+ Mature B-NHL","O-ICE","Inclusion Criteria:\n\n* Patients in first relapse or primary induction failure CD20 positive B-cell leukemia\u002Flymphoma including:\n\n  * Diffuse Large B-Cell Lymphoma\n  * Burkitt Lymphoma\n  * High Grade B-cell Lymphoma: Not Otherwise Specified (NOS)\n  * Primary mediastinal B-cell lymphoma (PMBL)\n  * CD20+ B-lymphoblastic lymphoma\n  * Follicular lymphoma, Grade III\n  * Karnofsky ≥ 60% for patients \\> 16 years of age and\n  * Lansky ≥ 60 for patients ≤ 16 years of age.\n  * Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study.\n  * Patients may not have received prior therapy with obinutuzumab (GA101)\n  * Radiation Therapy (XRT): Date of receiving prior XRT must be \\> 2 weeks for local palliative XRT (small port); \\> 6 months must have elapsed if prior craniospinal XRT or if \\> 50% radiation of pelvis; \\> 6 weeks must have elapsed if other substantial bone marrow radiation.\n  * Steroids: Patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy.\n  * Adequate organ function.\n\nExclusion Criteria:\n\n* Patients with newly diagnosed, previously untreated B-NHL.\n* Known congenital or acquired immune deficiency.\n* Prior solid organ transplantation.\n* Prior allogeneic stem cell transplant within 60 days or active acute Graft-vs-Host-Disease (GVHD) grade 3 or higher.\n* History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies\n* Uncontrolled hepatitis B and\u002For C infection","3 Years","31 Years",{"count":19,"type":20},[59],"The purpose of this study is to determine the safety of administering obinutuzumab as a single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ICE) chemotherapy and determine the response rate of this treatment for children, adolescents and young adults (CAYA) with relapsed CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL).",[27,28,147,574,575,576],"Primary Mediastinal B-cell Lymphoma","CD20+ Lymphoblastic Lymphoma","Follicular Lymphoma, Grade III","2025-08-07",{"date":579,"type":39},"2025-08-08",{"date":581,"type":39},"2015-08-21",{"date":583,"type":20},"2027-12",{"name":363,"class":105},{"id":586,"slug":587,"hasResults":11,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":21,"phases":594,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":47},"100542274","phase-1-autologouscd22-chimeric-antigen-receptor-cart-cells-in-wrecurrentrefractory-b-cell-lymphomas-100542274","NCT06340737","AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w\u002FRecurrent\u002FRefractory B Cell Lymphomas","Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas","Inclusion Criteria:\n\n* Disease: Must have histologically confirmed disease as defined by WHO 2016\\[117\\] of one of the following:\n\nFollicular Lymphoma, grade 1-3a\n\n1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.\n2. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.\n\nMantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.\n\n2\\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.\n\nHairy cell leukemia (HCL)\n\n1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \\\u003C11 g\u002FdL), thrombocytopenia (platelets\\\u003C100 x 10\\^9 \u002FL), or neutropenia (absolute neutrophil count below 1.5 x 10\\^9\u002FL); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;\n2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.\n\nLymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed\n\n1\\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy\n\n1\\. Prior therapies must include a i. BTKi ii. either chemotherapy and\u002For proteasome inhibitor 3. Requires treatment based on the recommendations from the Second International Workshop on WM 4. Requires the presence of serum IgM that is at least 2 times the upper limit of normal 5. Patients cannot require plasmapheresis for symptomatic hyperviscosity. 6. Patients cannot have symptomatic central nervous system involvement (Bing-Neel syndrome) that would prevent the assessment of neurotoxicity 7. Patients cannot have transformed to large B cell lymphoma Burkitt lymphoma (BL)\n\n1\\. Relapsed or refractory to front line chemoimmunotherapy; Participants with high-grade B-cell lymphoma with MYC and BCL2 and\u002ForBCL6 rearrangements will be excluded.\n\nMarginal zone lymphoma (MZL)\n\n1\\. Must have received 2 prior lines of therapy including rituximab in combination with chemotherapy or a BTKi\n\nHistologically confirmed Large B-cell lymphoma (LBCL) by WHO 2008 including:\n\ni. DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR ii. primary mediastinal (thymic) large B cell lymphoma; OR iii. transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma to DLBCL; OR iv. Follicular Lymphoma Grade 3B\n\n• Subjects with DLBCL, Follicular Lymphoma Grade 3B -or-\n\nSubjects with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation:\n\n1\\) Must have received an anthracycline regimen and an anti CD20 monoclonal antibody (unless documented CD20-negative) and be refractory or relapsed after second line of LBCL treatment. Subjects with a partial response to second line therapy must be ineligible for autologous transplant.\n\n* Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:\n\n  1. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL\n\n     Note: T cell\u002Fhistiocyte rich large B cell lymphoma is not eligible\n\n     The following criteria apply to all participants unless otherwise noted:\n\n  2\\. Measurable Disease:\n  1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\n     b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible\n  2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.\n  3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.\n\n  3\\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.\n\n  4\\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.\n\n  5\\. Meet required prior therapy washout windows prior to leukapheresis (see inclusion criteria for leukapheresis for details).\n\n  6\\. Participants with prior CAR therapy must be at least 30 days post CAR infusion and have \\\u003C 5% CD3+ cells express the previous CAR prior to apheresis, if a validated assay is available.\n\n  7\\. Toxicities from prior therapy stable or resolved (except for clinically non-significant toxicity and cytopenias covered in footnote).\n\n  8\\. Age ≥ 18 years of age. 9. Adequate performance status (ECOG 0, 1, or 2; or Karnofsky \\> 60%) 10. Adequate organ and marrow function as defined by:\n\n  \\- ANC ≥ 750\u002FuL\n  * Platelet count ≥ 50,000\u002FuL\n  * ALC ≥ 150\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \\\u003C 2 mg\u002FdL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg\u002Fdl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air ANC Platelet ALC Cr CreatCl AST\u002FALT Bilirubin LVEF O2 Sat\n  * 11\\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.\n\n    14\\. Must be able to provide informed consent (LAR is permitted if participant able to provide verbal assent).\n\nA participant will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n* Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n\n  2\\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety\n\n  3\\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.\n\n  4\\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and\u002For nucleic acid testing.\n\n  5\\. Active cerebrovascular ischemic\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.\n\n  6\\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.\n\n  7\\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n\n  8\\. Is pregnant or breastfeeding.\n\n  9\\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n\n  10\\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, or be likely to complete all protocol-required visits and procedures.",{"count":593,"type":20},148,[23],"This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed \u002F refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.",[76,119,597,77,28,352,479,378],"Hairy Cell Leukemia",[599,600,601,602,603,604],"lymphoma","leukemia","lymphodepleting chemotherapy","relapsed","refractory","systemic therapy","2025-08-04",{"date":577,"type":39},{"date":608,"type":39},"2024-03-29",{"date":610,"type":20},"2031-04",{"name":612,"class":105},"Stanford University",{"id":614,"slug":615,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":620,"enrollmentInfo":621,"targetDuration":4,"studyType":21,"phases":623,"briefSummary":624,"conditions":625,"keywords":631,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":642,"leadSponsor":644,"locationsCount":47},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":622,"type":20},56,[59],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[204,203,297,626,79,66,67,454,627,628,28,629,630,74,352,76,205,69],"Undifferentiated Leukemia","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia",[91,93,95,90,94,632,633,634,635,636,637,16],"PFS","TRM","GVHD","MMF","TBI","PTCy","2025-06-27",{"date":640,"type":39},"2025-07-01",{"date":304,"type":39},{"date":643,"type":20},"2028-10-22",{"name":104,"class":105},{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":653,"enrollmentInfo":654,"targetDuration":4,"studyType":21,"phases":656,"briefSummary":657,"conditions":658,"keywords":661,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":47},"100520762","phase-1-thiotepa-cyclophosphamide-clarithromycin-and-cytarabine-100520762","NCT06060782","Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine","Clinical Study on the Efficacy and Safety of Auto-HSCT in Adult Patients with Burkitt Lymphoma, Lymphoblastic Lymphoma, and Acute Lymphoblastic Leukemia Who Received TCCA Conditioning Regimen","TCCA","Inclusion Criteria:\n\n* 1\\. Voluntarily sign the informed consent form, which must be signed by the patient himself.\n\n  2\\. ALL patients confirmed by bone marrow cell morphology, immunology, and genetics; 3. PH+ALL patients who achieve s3CMR (definition: achieve molecular biological remission in the early stage of initial treatment (within 3 months) and maintain remission); 4. Ph-B-ALL patients who have reached MRD- after 3 courses of chemotherapy and continue to be MRD-; adult patients with Burkitt lymphoma and lymphoblastic lymphoma confirmed by histopathology and molecular genetics; 5. Adult patients with Burkitt lymphoma and lymphoblastoma, if the bone marrow is not involved, can achieve PR or above after induction; if the bone marrow is involved at the time of initial diagnosis, 3 courses of chemotherapy are required to reach MRD- and continue to be MRD-.\n\n  6\\. Patients receiving autologous hematopoietic stem cell transplantation (auto-HSCT); 7. Age ≥18 years and ≤65 years old, male or female; 8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2;\n\nExclusion Criteria:\n\n* 1\\. Have a history of cancer and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN), or prostate epithelium Internal carcinogenesis (PIN); 2. Known to be serologically positive for HIV, active hepatitis B, active hepatitis C virus or syphilis; 3. Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring; 4. Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment; 5. Received hematopoietic stem cell transplantation within the past 1 year; 6. Active heart disease, defined as one or more of the following:\n\n  1. Have a history of uncontrolled or symptomatic angina;\n  2. Myocardial infarction less than 6 months from study enrollment;\n  3. Have a history of arrhythmia that requires drug treatment or has severe clinical symptoms;\n  4. Uncontrolled or symptomatic congestive heart failure (\\>NYHA class 2);\n  5. The ejection fraction is lower than the lower limit of the normal range. 7. Patients who meet the following criteria:\n\n  \u003C!-- -->\n\n  1. Major surgery (except diagnostic surgery) is planned within 4 weeks before enrollment or during the study period, or the surgical wound has not fully healed before enrollment;\n  2. Those who have received (attenuated) live vaccines within 4 weeks before enrollment;\n  3. Patients with suspected active or latent tuberculosis;\n  4. Participate in other clinical trials one month before enrollment 8. Those who the researcher believes are not suitable for enrollment","65 Years",{"count":655,"type":20},28,[23],"This study is an observational study on the efficacy and safety of auto-HSCT in adult patients with Burkitt lymphoma, lymphoblastic lymphoma, and acute lymphoblastic leukemia who received TCCA conditioning regimen. The study plans to include 28 patients who received the TCCA regimen for pre-transplantation pretreatment before auto-HSCT. Maintenance treatment will be carried out after transplantation for 1 year to observe the efficacy and safety.",[28,659,660],"Lymphoblastic Lymphoma, Adult","Acute Lymphoblastic Leukemia, Adult",[662,663,664,665,666],"Thiotepa","Cyclophosphamide","Cladribine","Cytarabine","conditioning regimen","2025-03-04",{"date":669,"type":39},"2025-03-06",{"date":671,"type":39},"2024-03-06",{"date":673,"type":20},"2026-12-31",{"name":675,"class":105},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"id":677,"slug":678,"hasResults":11,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":11,"sex":16,"minAge":683,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":198,"phases":4,"briefSummary":687,"conditions":688,"keywords":692,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":697,"lastUpdatePostDateStruct":698,"startDateStruct":700,"completionDateStruct":702,"leadSponsor":703,"locationsCount":705},"100577301","immunotherapy-in-lymphoma-100577301","NCT06796517","Immunotherapy in Lymphoma","Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed\u002FRefractory Lymphoma Patients","Inclusion Criteria:\n\n* Adults aged 19 to 74 years.\n* Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma\n* Patients who have received immunochemotherapy as treatment for relapsed\u002Frefractory lymphoma\n\nExclusion Criteria:\n\n* Patients who have progressed to acute leukemia\n* Patients who developed solid tumor during treatment\n* Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)","19 Years","74 Years",{"count":686,"type":20},72,"The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed\u002Frefractory high grade B cell lymophoma patients. The main question it aims to answer is:\n\nDoes advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?\n\nResearchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.\n\nLaboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.",[689,690,691,325,28],"Relapsed\u002Frefractory High Grade B Cell Lymphoma","High Grade B-cell Lymphoma","Diffuse Large B Cell Lymphoma Relapsed",[693,694,695,696],"immunochemotherapy","B cell lymphoma","Relapsed","Refractory","2025-01-27",{"date":699,"type":39},"2025-01-28",{"date":701,"type":39},"2024-06-26",{"date":555,"type":20},{"name":704,"class":105},"Sung-Soo Park",2,{"id":707,"slug":708,"hasResults":11,"nctId":709,"briefTitle":710,"officialTitle":711,"acronym":4,"eligibilityCriteria":712,"healthyVolunteers":11,"sex":16,"minAge":713,"maxAge":17,"enrollmentInfo":714,"targetDuration":4,"studyType":21,"phases":715,"briefSummary":717,"conditions":718,"keywords":722,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":730,"lastUpdatePostDateStruct":731,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":47},"100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084","NCT05518383","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)","Inclusion Criteria:\n\n* Age at diagnosis 0 to 18 years.\n* The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL\n* Informed consent of the patient parents (guardians) to be treated\n\nExclusion Criteria:\n\n* previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency\n* hypersensitivity to rituximab or to ingredients of other IMPs.\n* no informed consent of the patient parents (guardians) to be treated","1 Day",{"count":57,"type":20},[716],"PHASE4","The aim of the trial is to evaluate the molecular characteristics and MDD\u002FMRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET\u002FCT in assessment of the completeness of remission.\n\nThe following primary study questions are going to be analyzed:\n\n* the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by \"second-line\" block VICI in order to improve results\n\nSecondary study questions will address\n\n* additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates\n* kinetics of immune reconstitution after treatment",[719,28,720,721,173],"Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Lymphoma","Primary CNS Lymphoma",[723,724,725,726,727,728,729],"B-cell mature non-Hodgkin's lymphoma","Burkitt's lymphoma","Diffuse large B-cell lymphoma","primary mediastinal lymphoma, primary CNS lymphoma","rituximab","children, adolescents","treatment","2022-08-25",{"date":732,"type":39},"2022-08-26",{"date":734,"type":39},"2022-05-25",{"date":736,"type":20},"2027-05-16",{"name":738,"class":105},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology"]