[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mantle-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mantle-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,78,0,25,[9,48,72,96,128,155,209,241,252,278,302,331,365,388,423,457,503,530,552,579,606,627,646,664,686],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053834","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-sonrotoclax-plus-zanubrutinib-compared-with-placebo-plus-zanubrutinib-in-adults-with-relapsedrefractory-mantle-cell-lymphoma-celestial-rrmcl-100053834",false,"NCT06742996","A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed\u002FRefractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)","A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)\n* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis\n* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator\n* Relapsed or refractory disease after the last line of therapy\n* Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)\n* Prior therapy with BTK degraders\n* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.\n* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug\n* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug\n* Known central nervous system involvement by lymphoma\n* Clinically significant cardiovascular disease\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed\u002Frefractory (R\u002FR) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.",[27,28],"Mantle Cell Lymphoma","B Cell Lymphoma",[30,31,32,33,34],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","sonrotoclax","BGB-11417","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-03-05",{"date":43,"type":21},"2032-03-30",{"name":45,"class":46},"BeOne Medicines","INDUSTRY",155,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100053419","phase-1-hdm2005-combination-therapy-in-relapsedrefractory-mantle-cell-lymphoma-100053419","NCT07697339","HDM2005 Combination Therapy in Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase Ib\u002FIII Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. Adult participants aged 18 years or older.\n2. Histologically confirmed mantle cell lymphoma with cyclin D1 overexpression or documented t(11;14).\n3. Relapsed or refractory mantle cell lymphoma after prior treatment with an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor, unless a BTK inhibitor was not suitable or was not tolerated.\n4. At least one measurable lesion according to the 2014 Lugano response criteria.\n5. Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part.\n6. Adequate organ and bone marrow function as defined in the protocol.\n7. Estimated life expectancy of more than 3 months.\n8. Willingness to provide archived or fresh tumor tissue for central pathology review, if available.\n9. Willingness to follow the study treatment plan, visit schedule, and contraceptive requirements.\n10. Written informed consent provided before any study-specific procedures.\n\nExclusion Criteria:\n\n1. Leukemic non-nodal mantle cell lymphoma.\n2. Known central nervous system involvement by lymphoma.\n3. Prior treatment with a ROR1-targeted therapy.\n4. Active or uncontrolled infection requiring systemic treatment.\n5. Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol.\n6. History or current evidence of interstitial lung disease, active interstitial lung disease, or radiation pneumonitis requiring steroid treatment.\n7. Clinically significant cardiovascular or cerebrovascular disease that may increase study risk.\n8. Prior allogeneic hematopoietic stem cell transplantation with active or clinically significant graft-versus-host disease, or need for systemic immunosuppressive treatment for graft-versus-host disease.\n9. Prior solid organ transplantation.\n10. Other active malignancy or malignancy with a clinically significant risk of recurrence, except for certain adequately treated cancers as defined in the protocol.\n11. Unresolved clinically significant toxicity from prior anti-cancer therapy.\n12. Recent anti-cancer therapy, investigational treatment, major surgery, or radiotherapy within the protocol-defined washout period.\n13. Known allergy or contraindication to any study treatment or its components.\n14. Active autoimmune disease or immunodeficiency requiring systemic treatment, except for protocol-defined stable conditions.\n15. Pregnancy, breastfeeding, or planned pregnancy during the study.\n16. Any medical, psychiatric, laboratory, or social condition that, in the investigator's judgment, may interfere with study participation, study assessments, or participant safety.",{"count":56,"type":21},40,[58],"PHASE1","This is a Phase Ib\u002FIII, multicenter, open-label clinical study of HDM2005 in combination with rituximab and lenalidomide in adult patients with relapsed or refractory mantle cell lymphoma.\n\nMantle cell lymphoma is a type of non-Hodgkin lymphoma. Some patients have disease that comes back after treatment or does not respond well to available treatments. This study is designed to evaluate whether adding HDM2005 to rituximab and lenalidomide may provide clinical benefit for patients with relapsed or refractory mantle cell lymphoma who have previously received an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor.\n\nThe study includes two parts. In the Phase Ib part, participants will receive HDM2005 in combination with rituximab and lenalidomide. The main goals of this part are to evaluate the safety and tolerability of the combination, assess preliminary anti-tumor activity, and determine the recommended dose of HDM2005 for the Phase III part.\n\nIn the Phase III part, eligible participants will be randomly assigned to receive either HDM2005 at the recommended Phase III dose in combination with rituximab and lenalidomide, or the investigator's choice of comparator treatment with rituximab plus lenalidomide or bendamustine plus rituximab. The main goals of the Phase III part are to compare the anti-tumor activity and clinical benefit of the HDM2005 combination with the comparator treatments. The main measures of efficacy include objective response rate and progression-free survival, assessed according to the 2014 Lugano response criteria. The study will also evaluate safety, pharmacokinetics, immunogenicity, overall survival, duration of response, and other measures of anti-tumor activity.",[27],[62,63],"ROR1-ADC","Mantle cell lymphoma","NOT_YET_RECRUITING","2026-07-09",{"date":38,"type":39},{"date":36,"type":21},{"date":69,"type":21},"2028-12-01",{"name":71,"class":46},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100514305","phase-3-testing-continuous-versus-intermittent-treatment-with-the-study-drug-zanubrutinib-for-older-patients-with-previously-untreated-mantle-cell-lymphoma-100514305","NCT05976763","Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma","A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma","Inclusion Criteria:\n\n* • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and\u002For t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center\n\n  * Any stage allowed (stage I-IV)\n\n    * Presence of measurable disease, defined as \\>= 1 nodal lesion that is \\> 1.5 cm in longest diameter or \\>= 1 extranodal lesion that is \\> 1 cm in longest diameter\n    * Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg\u002Fday (or equivalent) for up to 7 days\n    * No prior systemic treatment for mantle cell lymphoma\n    * No prior radiation treatment for stage I MCL\n    * No prior exposure to a BTK inhibitor or anti-CD20 monoclonal antibody\n    * No prior stem cell transplant\n    * Age \\>= 70 years OR age \\>= 60 to \\\u003C 70 years with comorbidities precluding autologous stem cell transplantation (autoSCT) including at least one of the following: a) cardiac ejection fraction (EF) \\\u003C 45%, b) diffusing capacity for carbon monoxide \\\u003C 60% predicted; c) creatinine clearance \\\u003C 70 but \\> 30ml\u002Fminute (min); d) Eastern Cooperative Oncology Group (ECOG) performance status of 2, which poses an unacceptable risk of toxicity for high-dose therapy and stem cell transplantation; or e) Cumulative Illness Rating Scales (CIRS) total score \\> 6\n    * ECOG Performance Status 0-2\n    * Absolute neutrophil count (ANC) \\>= 750\u002Fmm\\^3 (without growth factor support within 7 days)\n    * Platelet count \\>= 75,000\u002Fmm\\^3 (or \\>= 50,000\u002Fmm\\^3 for patients with bone marrow involvement of lymphoma) without growth factor support or transfusion within 7 days\n    * Creatinine clearance \\>= 30 mL\u002F min determined by either: a) Estimation using the Cockcroft-Gault equation or b) Measurement by nuclear medicine scan or 24 hour urine collection\n    * Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless documented Gilbert's syndrome)\n    * Aspartate transferase (AST) \u002F alanine transaminase (ALT) =\\\u003C 3 x ULN\n    * Patients should not be considered candidates for stem cell transplant or must have declined a stem cell transplant strategy\n    * No clinically significant cardiovascular disease including the following\n  * Unstable angina within 3 months before registration\n  * New York Heart Association class III or IV congestive heart failure\n  * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * QT correction formula (QTcF) \\> 480 msecs based on Fredericia's formula\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n\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    * No active Hepatitis B or Hepatitis C infection. Patients with prior hepatitis B virus (HBV) exposure (positive HBV core antibody and\u002For surface antigen) are eligible if they have no detectable viral load, and are taking appropriate prophylactic antiviral therapy to prevent reactivation. Patients with history of hepatitis C virus (HCV) 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    * No history of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n    * No history of stroke or intracranial hemorrhage within 6 months prior to registration\n    * No disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Patient must be able to swallow pills\n    * Potential trial participants should have recovered from major surgery\n    * No vaccination with a live vaccine within 35 days prior to registration\n    * No hypersensitivity to zanubrutinib or rituximab or any of the other ingredients of the study drugs\n    * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.\n    * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment\n    * Avoid use of moderate CYP3A4 inhibitors, PGP inhibitors, and moderate CYP3A4 inducers\n    * Archival tissue must be available for submission in all patients for histopathology review, though participation in correlative substudies is optional","60 Years",{"count":81,"type":21},421,[24],"This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.",[27],"2026-07-01",{"date":87,"type":39},"2026-07-02",{"date":89,"type":39},"2023-10-20",{"date":91,"type":21},"2038-08-31",{"name":93,"class":94},"Alliance for Clinical Trials in Oncology","OTHER",237,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":127},"100494895","observational-study-of-cardiac-arrhythmias-during-treatment-with-btk-inhibitors-or-venetoclax-100494895","NCT05724121","Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently receiving or planning to receive a BTKi or venetoclax.\n2. Male or female, aged 18 or older\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Ability of subject to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months\n2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.","110 Years",{"count":104,"type":21},135,"OBSERVATIONAL","Background:\n\nBruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart.\n\nObjective:\n\nTo identify and monitor the effects of BTKi on the heart.\n\nEligibility:\n\nPeople aged 18 and older currently receiving or planning to receive BTKi or venetoclax.\n\nDesign:\n\nParticipants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit.\n\nParticipants will undergo multiple tests:\n\nA physical exam, including collection of blood and saliva.\n\nA test that measures heart activity via stickers placed on the chest.\n\nA test that uses sound waves to capture images of the heart.\n\nAn exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises.\n\nStress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken.\n\nParticipants may wear a device to monitor their heart at home.\n\nParticipants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.",[108,109,27,110,111,112],"Chronic Lymphocytic Leukemia (CLL)","Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia","Sudden Cardiac Death","Cardiac Arrhythmias","Hematologic Malignancies",[114,108,115,116,117,118],"SUDDEN CARDIAC DEATH","Ibrutinib Treatment","Atrial Fibrillation\u002FFlutter","Ventricular Arrhythmias","Natural History",{"date":87,"type":39},{"date":121,"type":39},"2023-03-01",{"date":123,"type":21},"2027-04-08",{"name":125,"class":126},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100627781","phase-2-study-with-glofitamab-in-patients-with-mcl-and-inadequate-response-or-relapse-following-car-t-cell-therapy-100627781","NCT07453095","Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy","A Phase II, Multicenter Study of GlOfitamab in Patients With Mantle Cell Lymphoma and inaDequate Response or Relapse Following CAR T-cell Therapy (GOLD)","Inclusion Criteria:\n\n1. Able to provide written informed consent forms approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.\n2. Histologically confirmed MCL after CAR T-cells failure (CD20+ by flow cytometry or immunohistochemistry). Note: Availability of archival material is mandatory for the study to perform central pathology review. Central pathology confirmation is not required to start treatment.\n3. Age ≥ 18.\n4. Patients who received CAR T-cells therapy for R\u002FR MCL at least 30 days prior to signing the informed consent form and who meet one of the following situations:\n\n   * Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90);\n   * Partial response (PR) at D+90 after CAR-T cells infusion;\n   * Relapsed disease at any time after CAR-T cells infusion.\n5. No persistent CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of severe neurotoxicity grade \\> 3\n6. Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted).\n7. Adequate hematological counts are defined as follows:\n\n   * Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL unless due to bone marrow involvement by lymphoma;\n   * Platelet count ≥ 50.000\u002Fmm3 unless due to bone marrow involvement by lymphoma;\n   * Hemoglobin ≥ 8.0 g\u002FdL.\n8. Adequate renal function defined as follows:\n\n   \\- Creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula).\n9. Adequate hepatic function per local laboratory reference range as follows (unless due to lymphoma):\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN;\n   * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).\n10. Participants must be able to adhere to the study visit schedule and other protocol requirements.\n11. Life expectancy \\> 12 weeks.\n12. ECOG Performance Status of 0, 1, or 2.\n13. Women of childbearing potential must have a negative pregnancy test at screening.\n14. Women of childbearing potential must take necessary precautions to avoid pregnancy while receiving study treatments and for 2 months after the last dose of glofitamab, for 18 months after the last dose of obinutuzumab and for 3 months after the last dose of tocilizumab.\n15. Male patient with a female partner of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 2 months after the last dose of glofitamab, for 3 months after the last dose of obinutuzumab and for 2 months after the last dose of tocilizumab.\n\nExclusion Criteria:\n\n1. Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).\n2. Participants not able to give consent.\n3. History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n   * Grade ≥ 3 adverse events except for Grade 3 endocrinopathy managed with replacement therapy;\n   * Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.\n4. Patients with history of macrophage activation syndrome (MAS) \u002F hemophagocytic lymphohistiocytosis (HLH).\n5. Allogeneic hematopoietic stem cell transplantation.\n6. History of progressive multifocal leukoencephalopathy (PML).\n7. History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n8. CNS involvement with lymphoma.\n9. Participant has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug.\n10. Cardiovascular disease \\[NYHA class ≥2\\].\n11. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.\n12. Evidence of other clinically significant uncontrolled condition(s) included, but not limited to:\n\n    1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;\n    2. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) require treatment. Note: participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;\n13. HIV seropositivity.\n14. If female, the patient is pregnant or breast-feeding.",{"count":136,"type":21},41,[138],"PHASE2","This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.",[27],[27,31,142,143,144],"CAR T cell","Inadequate response","Relapse","2026-06-24",{"date":147,"type":39},"2026-06-25",{"date":149,"type":39},"2026-06-05",{"date":151,"type":21},"2030-06-15",{"name":153,"class":94},"Fondazione Italiana Linfomi - ETS",14,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":79,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":194,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":127},"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.",{"count":20,"type":21},[138],"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).",[166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193],"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","Burkitt 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",[195,17,196,197,198,199,200],"AML","MDS","NHL","CLL","CML","SLL","2026-06-23",{"date":147,"type":39},{"date":204,"type":39},"2018-03-30",{"date":206,"type":21},"2028-06-10",{"name":208,"class":94},"Masonic Cancer Center, University of Minnesota",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100641819","connected-blood-pressure-monitoring-in-patients-with-hematologic-malignancies-initiating-covalent-btk-inhibitors-100641819","NCT07592481","Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors","HEMO-CONNECT","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of lymphoid malignancy: chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, Waldenström macroglobulinemia, or mantle cell lymphoma\n* Initiation of oral BTK inhibitor therapy (ibrutinib, acalabrutinib, or zanubrutinib), in treatment-naive or relapsed patients\n* Affiliation with a social security system\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Known cognitive impairment\n* No internet access\n* Individuals under guardianship, curatorship, or legal protection",{"count":56,"type":21},[218],"NA","This pilot prospective study aims to evaluate adherence to home blood pressure monitoring using connected blood pressure (BP) devices in patients with malignant B-cell hemopathies initiating covalent Bruton tyrosine kinase inhibitors (cBTKi). The objective is to determine whether digital BP monitoring improves early detection and management of BTKi-induced hypertension over 6 months.",[108,221,222,181,223,27],"Follicular Lymphoma ( FL)","Waldenstrom Macroglobulinaemia","Marginal Zone B Cell Lymphoma",[225,226,227,228,229,230,231,232],"BTK inhibitor","Hypertension","Telemonitoring","Connected device","Blood pressure","Lymphoid malignancies","Advanced practice nursing","Cardio-oncology","2026-06-18",{"date":235,"type":39},"2026-06-22",{"date":85,"type":21},{"date":238,"type":21},"2027-12-31",{"name":240,"class":94},"Centre Hospitalier de la côte Basque",{"id":242,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":25,"conditions":245,"keywords":246,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":250,"locationsCount":251},"100573185",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34],{"date":235,"type":39},{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},152,{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":261,"type":21},645,[58,138],"Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[265,266,180,267,268,177,178,27,269],"B-cell Malignancy","Marginal Zone Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Diffuse Large B Cell Lymphoma","2026-06-17",{"date":233,"type":39},{"date":273,"type":39},"2021-09-13",{"date":275,"type":21},"2029-11",{"name":45,"class":46},127,{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":293,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":127},"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":286,"type":21},36,[58],"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).",[290,186,27,180,181,291,269,178,292,267],"Refractory Non-Hodgkin Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Transformed Lymphoma",[294],"CAR-T Therapy",{"date":235,"type":39},{"date":297,"type":39},"2020-09-11",{"date":299,"type":21},"2026-10-31",{"name":301,"class":94},"C. Babis Andreadis",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100595229","phase-2-a-study-to-evaluate-acalabrutinib-in-combination-with-the-r-chop-standard-of-care-for-previously-untreated-mantle-cell-lymphoma-in-spain-100595229","NCT07029737","A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain","The SOUND-MCL Study: A Single-arm, Open-label, Multicenter, Phase II Study of Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain","SOUND-MCL","INCLUSION CRITERIA:\n\n1. Adult men or women.\n2. Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and\u002For overexpression of cyclin D1 in association with other relevant markers.\n3. MCL requiring treatment and for which no prior systemic anticancer therapies have been received.\n4. Unsuitable for autologous stem cell transplantation.\n5. Presence of radiologically measurable lymphadenopathy, splenomegaly and\u002For extranodal lymphoid malignancy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.\n7. Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest.\n8. Men must agree to refrain from sperm donation during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest.\n9. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing tablets without difficulty.\n10. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).\n11. WOCBP who are sexually active must use highly effective methods of contraception during the study treatment and for 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is the longest.\n12. Male patients should use barrier contraception from the time of screening until 12 months after the last dose of rituximab or cyclophosphamide, 6 months after the last dose of doxorubicin, 30 days after the last dose of vincristine, and 2 days after the last dose of acalabrutinib, whichever is longest. Male patients wishing to father children in the future should be advised to arrange for the freezing of sperm prior to the start of study treatment.\n\nEXCLUSION CRITERIA:\n\n1. History of prior malignancy except for the following:\n\n   1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening and felt to be at low risk for recurrence by treating physician.\n   2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanomatous skin cancer.\n   3. Adequately treated carcinoma in situ without current evidence of disease.\n2. Subjects for whom the goal of therapy is tumor debulking before stem cell transplant.\n3. Subjects who are deemed by the treating physician to be unfit to tolerate the R-CHOP regimen.\n4. Any history of central nervous system (CNS) lymphoma or leptomeningeal disease.\n5. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).\n6. Major surgical procedure within 28 days before first dose of study drug.\n7. Significant cardiovascular disease such as uncontrolled or untreated symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.\n8. Absolute neutrophil count (ANC) \\\u003C1.0 x 109\u002FL or platelet count \\\u003C75 x 109\u002FL; for subjects with disease involvement in the bone marrow, ANC \\\u003C0.75 x 109\u002FL or platelet count \\\u003C50 x 109\u002FL. Subjects will only be considered eligible if peripheral blood counts can be maintained independent of growth factors or transfusions during the screening period.\n9. Total bilirubin \\>1.5 x upper limit normal (ULN) unless other reason known; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \\>2.5 x ULN.\n10. Estimated creatinine clearance of \\\u003C30 mL\u002Fmin, calculated using the formula of Cockcroft and Gault \\[(140-age) • mass (kg)\u002F(72 • creatinine mg\u002FdL) • multiply by 0.85 if female\\].\n11. Prothrombin time\u002Finternational normalized ratio (INR) or activated partial thromboplastin time (aPTT) (in the absence of a lupus anticoagulant) \\>2.0 x ULN. Exception: Subjects receiving a vitamin K antagonist are excluded; however, those receiving other anticoagulant therapy who have a higher INR\u002FaPTT may be permitted to enroll to this study after discussion with the medical monitor.\n12. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.\n13. Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti-infective treatment within 2 weeks before first dose of study drug.\n14. Known history of infection with human immunodeficiency virus (HIV).\n15. Ongoing immunosuppressive therapy, including systemic corticosteroids within 2 weeks before the first dose of study drug.\n16. Known history of anaphylaxis or hypersensitivity to any study drug, or any of their components.\n17. Serologic status reflecting active hepatitis B or C infection.\n\n    1. Subjects who are anti-HBc positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result before the first dose of study drug. Those who are HbsAg positive or hepatitis B PCR positive will be excluded.\n    2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before the first dose of study drug. Those who are hepatitis C PCR positive will be excluded.\n18. Received a live virus vaccination within 28 days of first dose of study drug.\n19. History of stroke or intracranial hemorrhage within 6 months of first dose of study drug.\n20. History of bleeding diathesis.\n21. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.\n22. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.\n23. Requires treatment with a strong CYP3A inhibitor\u002Finducer.\n24. Concurrent participation in another therapeutic clinical trial.\n25. Active cytomegalovirus (CMV) infection (active viremia as evidenced by positive PCR result for CMV DNA).\n26. History of confirmed progressive multifocal leukoencephalopathy (PML).\n27. Pregnant or breastfeeding women.","130 Years",{"count":312,"type":21},55,[138],"This is a single-arm, open-label, multicenter, non-indication seeking phase II trial to describe the efficacy and safety of patients with mantle cell lymphoma (MCL) receiving acalabrutinib in combination with R-CHOP for the front-line treatment of MCL in Spain.\n\nAcalabrutinib will be administered until disease progression if medically appropriate, along with R-CHOP based on institutional standards. After 6 cycles of acalabrutinib in combination with R-CHOP, subjects who tolerate treatment and not progressing, will then receive monotherapy acalabrutinib. In addition, subjects who achieve a response (PR or greater) will receive maintenance rituximab every other 28-day cycle for a maximum of 12 additional doses. Thereafter, subjects receive monotherapy acalabrutinib until disease progression or treatment discontinuation.",[316],"Mantle-cell Lymphoma",[318,319,31,320],"Acalabrutinib","Previously untreated mantle-cell lymphoma","R-CHOP","2026-06-10",{"date":323,"type":39},"2026-06-11",{"date":325,"type":39},"2025-09-05",{"date":327,"type":21},"2028-12-15",{"name":329,"class":46},"AstraZeneca",22,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100559431","phase-1-a-study-of-azd0486-monotherapy-or-in-combination-with-other-anti-cancer-agents-for-mature-b-cell-malignancies-100559431","NCT06564038","A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies","A Phase I\u002FII Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies","Soundtrack-E","Inclusion Criteria:\n\nMaster Inclusion Criteria applicable to all substudies:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Contraception use during treatment and at least 90 days after final dose.\n* Confirmed CD19 expression if prior anti-CD19 therapy.\n\nSubstudy 1 Specific Inclusion Criteria:\n\n* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.\n* SLL: at least 1 measurable site per Lugano.\n* Absolute lymphocyte count (ALC) \\\u003C25000 cells\u002FmcL.\n* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL\u002FSLL.\n* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.\n\nSubstudy 2 Specific Inclusion Criteria:\n\n* MCL diagnosis per WHO.\n* Clinical Stage II, III, or IV by Ann Arbor Classification.\n* At least 1 measurable site per Lugano.\n* ALC \\\u003C 25000 cells\u002FmcL.\n* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.\n\nSubstudy 3 Specific Inclusion Criteria:\n\n* At least 1 measurable site as per Lugano.\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Participant must be no older than 79 years of age at the time of signing ICF.\n* Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.\n* Cohort 3A:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. R\u002FR B-NHL after at least 1 prior lines of systemic therapy.\n  3. International Prognostic Index (IPI) 2-5.\n* Cohort 3B:\n\n  1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.\n  2. IPI score of 2 to 5.\n\nExclusion Criteria:\n\nMaster Exclusion Criteria applicable to all substudies:\n\n* Central nervous system (CNS) lymphoma.\n* Surgery within 14 days of study drug.\n* Clinically significant cardiovascular (CV) disease.\n* Unresolved Grade \\>2 AEs from prior anticancer therapy (except alopecia or fatigue).\n* Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.\n* Radiation therapy within 28 days.\n* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.\n* Prior Grade \\> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.\n* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.\n* Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).\n\nSubstudy 1 Specific Exclusion Criteria:\n\n* CLL\u002FSLL transformation to more aggressive form of lymphoma.\n* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.\n\nSubstudy 3 Specific Exclusion Criteria:\n\n* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).\n* Cumulative dose of anthracycline \\>150 mg\u002Fm2.",{"count":340,"type":21},408,[58,138],"The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies",[344,178,316,345,346],"Chronic Lymphocytic Leukaemia","Large B-cell Lymphoma","B-cell Non-Hodgkin Lymphoma",[348,349,350,318,351,352,353,354,355,356],"IgG4 fully human CD19xCD3 bispecific T-cell engager","B cell lymphoma","Subcutaneous","Prednisone","Rituximab","Cyclophosphamide","Vincristine","Doxorubicin","Surovatamig","2026-06-09",{"date":321,"type":39},{"date":360,"type":39},"2025-01-30",{"date":362,"type":21},"2029-06-11",{"name":329,"class":46},64,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},"100569664","phase-1-a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-100569664","NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":373,"type":21},258,[58,138],"The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[177,198,27,31],[378,379],"CLL previously untreated","Hematological Malignancies",{"date":381,"type":39},"2026-06-08",{"date":383,"type":39},"2025-01-23",{"date":385,"type":21},"2032-11-30",{"name":45,"class":46},17,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":404,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":397,"type":21},700,[24],"The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[177,178,27,180,401,402,403],"Diffuse Large B-cell Lymphoma","Waldenstrom Macroglobulinemia","Chronic Graft Versus Host Disease",[405,406,63,407,408,409,410,411,412,413],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-06-04",{"date":149,"type":39},{"date":417,"type":39},"2013-09-09",{"date":419,"type":21},"2029-12-31",{"name":421,"class":46},"Janssen Research & Development, LLC",175,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":430,"sex":17,"minAge":431,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":127},"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,"6 Months",{"count":433,"type":21},60,[138],"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.",[166,168,167,437,438,186,439,440,441,185,181,27,442,443,183,444,445,446,447],"Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Hodgkin Lymphoma","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":450,"type":39},"2026-05-29",{"date":452,"type":39},"2021-01-25",{"date":454,"type":21},"2029-03-12",{"name":456,"class":94},"Fred Hutchinson Cancer Center",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":127},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":465,"type":21},27,[138],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[469,470,471,472,473,474,475,476,477,478,479,480,481,482,441,483,484,27,485,486,188,443,487,488,489,490,491,492,493],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hepatocellular Carcinoma","Lung Carcinoma","Malignant Solid Neoplasm","Melanoma","Merkel Cell Carcinoma","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-05-15",{"date":496,"type":39},"2026-05-18",{"date":498,"type":39},"2025-12-18",{"date":500,"type":21},"2026-12-18",{"name":502,"class":94},"Mayo Clinic",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":529},"100619174","phase-2-sonrotoclax-plus-zanubrutinib-in-patients-with-relapsedrefractory-mantle-cell-lymphoma-planned-for-standard-of-care-car-t-cell-therapy-100619174","NCT07341191","Sonrotoclax Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy","A Phase II Study of Sonrotoclax Plus Zanubrutinib in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy","Inclusion Criteria:\n\n* Have histologically confirmed mantle cell lymphoma that is relapsed or refractory after at least one prior line of systemic therapy\n* Eligible for and planned to receive Health Canada approved CAR-T.\n* Have a formalin fixed paraffin embedded tumour tissue block available and must have provided informed consent for the release of the block.\n* Presence of radiologically documented disease.\n* Measurable disease (one site bidimensionally measurable).\n* Age ≥ 18 years.\n* Have an ECOG performance status of 0, 1 or 2\n* Anticipated life expectancy of ≥ 6 months\n* Adequate hematologic and biochemical parameters\n* Must have received prior systemic therapy as shown below;\n* At least one line of systemic therapy including a Bruton's Tyrosine Kinase inhibitor (BTKi).\n* Participants who have previously received venetoclax, sonrotoclax, or any other BCL2 inhibitor (BCL2i) are eligible as long as progressive disease did not occur within 6 months of the last dose of BCL2i. Participants with progressive disease during BCL2i therapy or within 6 months of last dose are not eligible.\n* Participants must enter the study while on a BTKi or enroll to a substudy of the protocol to receive zanubrutinib for a minimum duration prior to enrolling to the main study.\n* Participants previously exposed to zanubrutinib are eligible irrespective of response to treatment.\n* Participants entering the study while on a BTKi must have their BTKi switched to zanubrutinib supplied through the study.\n* Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies.\n* Adequate washout must be followed per protocol.\n* Prior high-dose myelosuppresive radiation is permitted ≥28 prior to enrollment.\n* Previous major surgery is permitted ≥28 days prior to enrollment. Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria\n\n* • Participants on active anticancer therapy for other advanced or metastatic malignancies.\n* Concurrent treatment with other anti-cancer therapy\n* Serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol.\n* Known hypersensitivity to the study drug(s) or their components.\n* Prior CD19-directed CAR-T at any time, autologous hematopoietic cell transplantation within 6 weeks, or allogeneic hematopoietic cell transplantation within 3 months. Allogeneic hematopoietic cell transplantation recipients must be free of clinically-significant graft-versus-host disease (GvHD) and must be off immunosuppression for GvHD for at least 4 weeks before enrollment.\n* Untreated and\u002For uncontrolled cardiovascular conditions and\u002For symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year.\n* Active, uncontrolled bacterial, fungal, or viral infection within 14 days prior to enrollment\n* Pregnant or breastfeeding women.\n* Inability to discontinue use of moderate or strong CYP3A inducers or inhibitors during the ramp-up treatment period with sonrotoclax.\n* Live vaccination within 4 weeks prior to enrollment or who plan to receive a live vaccine during treatment or within 90 days post last dose.\n* Inability to swallow capsules or tablets or have any diseases significantly affecting GI function\n* Active central nervous system (CNS) disease; Participants with stable CNS disease are eligible.\n* Growth factors within 28 days prior to enrollment.",{"count":56,"type":21},[138],"The purpose of this study is to evaluate the effects of adding two oral medications (sonrotoclax plus zanubrutinib) to standard of care chimeric antigen receptor (CAR-T) cell therapy in participants with mantle cell lymphoma.",[27],[515,516,517,225,518],"CAR-T","Relapsed","Refractory","BCL2 inhibitor","2026-05-11",{"date":521,"type":39},"2026-05-14",{"date":523,"type":21},"2026-06-30",{"date":525,"type":21},"2030-12-31",{"name":527,"class":528},"Canadian Cancer Trials Group","NETWORK",2,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":529},"100613021","phase-2-obinutuzumab-zanubrutinib-and-lenalidomide-in-first-line-treatment-of-mantle-cell-lymphoma-100613021","NCT07261163","Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma","Obinutuzumab, Zanubrutinib, and Lenalidomide as First-Line Therapy for Mantle Cell Lymphoma: A Prospective, Single-Arm, Open-Label, Multicenter Study","Inclusion Criteria:\n\n1. Age between 18 and 80 years inclusive, both genders are eligible.\n2. Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.\n3. No prior systemic therapy for MCL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Adequate organ function, defined as:\n\n   1. Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹\u002FL;Platelet count (PLT) ≥ 75 × 10⁹\u002FL;\n   2. Biochemical tests must meet the following criteria::\n\n      Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL\u002Fmin, calculated by the Cockcroft-Gault formula;\n   3. Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram.\n6. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g., intrauterine device, hormonal contraception, or condom use) during the study and for 6 months after the last dose of study drug. Male subjects whose partners are of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 6 months after the last dose of study drug.\n7. Willing and able to provide written informed consent and comply with the study follow-up requirements.\n\nExclusion Criteria:\n\n1. Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.\n2. Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.\n3. History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by PAP smear.\n4. Prior treatment with investigational drugs.\n5. Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.\n6. Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg\u002Fday prednisone or equivalent).\n7. History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or premedication agents.\n8. Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection with both HBV and HCV; Pregnant or breastfeeding women; subjects of childbearing potential unwilling or unable to use effective contraception; Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).\n9. Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol.\n10. Other conditions deemed unsuitable for enrollment by the investigator.","80 Years",{"count":539,"type":21},37,[138],"This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.",[27],"2026-05-10",{"date":545,"type":39},"2026-05-13",{"date":547,"type":39},"2025-12-20",{"date":549,"type":21},"2029-07-31",{"name":551,"class":94},"Institute of Hematology & Blood Diseases Hospital, China",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":537,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":567,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":127},"100581617","phase-2-cd70-targeted-immunopet-imaging-of-malignant-cancers-100581617","NCT06852638","CD70-targeted immunoPET Imaging of Malignant Cancers","CD70-targeted PET\u002F CT in the Diagnosis of Malignant Cancers","Inclusion Criteria:\n\n* Aged 18-80 year-old and of either sex；\n* Histologically confirmed diagnosis of renal cancer (especially ccRCC)\u002Flymphoma\u002FNPC or suspected renal cancer\u002Flymphoma\u002FNPC by diagnostic imaging;\n* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.\n\nExclusion Criteria:\n\n* Pregnancy；\n* Severe hepatic and renal insufficiency;\n* Allergic to single-domain antibody radiopharmaceuticals.",{"count":20,"type":21},[138],"This study aims to determine the value of cluster of differentiation (CD70)-targeted immuno-positron emission tomography\u002Fcomputed tomography (immunoPET\u002FCT) imaging for diagnosing human malignancies, including renal cell carcinoma (particularly clear cell renal cell carcinoma), lymphoma, and nasopharyngeal carcinoma (NPC), among others.",[563,564,169,565,180,27,566],"Renal Cancer","Renal Clear Cell Carcinoma","Lymphoma, Large B-Cell, Diffuse","Nasopharyngeal Carcinoma",[568,569,563,169,566],"The cluster of differentiation (CD70)","ImmunoPET","2026-05-07",{"date":572,"type":39},"2026-05-12",{"date":574,"type":39},"2024-12-23",{"date":576,"type":21},"2026-12-23",{"name":578,"class":94},"RenJi Hospital",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":127},"100507421","phase-1-feasibility-and-safety-of-collecting-and-combining-autologous-hematopoietic-stem-cells-with-chimeric-antigen-receptor-car-t-cell-therapy-in-subjects-with-relapsedrefractory-hematological-malignancies-100507421","NCT05887167","Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","IIT2022-04-Sasine-CAR-T: A Phase 1 Single-arm, Open-label Study to Evaluate the Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 - 85 years.\n* Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.\n* Relapsed or refractory disease, defined by the following:\n\n  * Disease progression after last regimen, or\n  * Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.\n* Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.\n* Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.\n* Eastern cooperative oncology group (ECOG) performance status 0 - 2.\n* Adequate hematologic, hepatic, and cardiac function\n* Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.\n* Willing to comply to research specimen collection as specified in the protocol.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.\n* History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, or any autoimmune disease with CNS involvement.\n* Doses of corticosteroids of greater than or equal to 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.\n* Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.\n* Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n* Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.","85 Years",{"count":588,"type":21},20,[58],"The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed\u002Frefractory (r\u002Fr) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r\u002Fr hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.",[592,345,168,27,188,269],"Hematologic Malignancy",[594,595,596,597],"CAR T-cell therapy","autologous hematopoietic stem cells","CAR T","CAR T therapy","2026-05-01",{"date":570,"type":39},{"date":601,"type":39},"2024-03-02",{"date":603,"type":21},"2027-12-15",{"name":605,"class":94},"Joshua Sasine, MD, PhD",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":127},"100479906","phase-2-phase-ii-study-of-pirtobrutinib-with-venetoclax-in-relapsed-refractory-mcl-mantle-cell-lymphoma-patients-100479906","NCT05529069","Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients","Inclusion Criteria:\n\n1. Confirmed diagnosis of mantle cell lymphoma in tissue biopsy by hematopathology with\u002Fwithout chromosome translocation t(11;14), (q13;q32) and\u002For overexpress cyclin D1 in tissue biopsy. Cyclin D1 negative MCL (confirmed by hematopathology at MDACC are allowed).\n2. The patient is able to take oral medications\n3. Relapsed MCL (irrespective of prognostic factors) including any lines or prior therapy or patients who had prior ibrutinib, acalabrutinib, zanubrutinib, other BTK inhibitor or anti CD19-CART therapy, single agent or in combination (without prior venetoclax) or relapsed high risk MCL including any or all of the following (Blastoid\u002Fpleomorphic histology), High Ki-67 (≥50%), TP53 mutated or del17p by FISH, NSD2, NOTCH2, CDKN2A mutated or MYC positive by FISH or MYC, Bcl2 amplification, complex karyotype or high risk biologic MIPI score\n4. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n5. Age from \\>=18 years at the time of signing the informed consent.\n6. Patients may have at least 1 site of radiographically assessable disease (i.e., lymph node longest diameter \\[LDi\\] \\>= 1.5 cm, not necessary for disease assessable by positron emission tomography \\[PET\\]\u002Fcomputerized tomography \\[CT\\], extra nodal site \\>= 1.0 cm in LDi. Patients with BM only or GI only relapse are allowed.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.\n8. Disease free of prior malignancies with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \"in situ\" of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy \\> 3 years pertaining to prior malignancy. PI could use judgment in the best interest of patients.\n9. Patients must have relapsed or refractory MCL (irrespective of prior BTK inhibitor or anti CD19 CART exposure).\n10. Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (patients with an elevated prothrombin time and known lupus anticoagulant may be eligible for participation after consulting the IND sponsor).\n11. Adequate BM function independent of growth factor or PRBC or platelet transfusion support (within 14 days of Screening assessment and criteria must be met on C1D1 without transfusion\u002FG-CSF within 7 days of assessment, per local laboratory reference range at screening as follows:\n\n    1. platelet count \\>=50, 000\u002Fmm3;\n    2. absolute neutrophil count (ANC) \\>= 1000\u002Fmm3 unless cytopenia is clearly due to marrow involvement from MCL\n    3. total hemoglobin \\>= 8 g\u002FdL (without transfusion support within 2 weeks of screening); If any of the above-mentioned cytopenias (a-c) are present due to significant BM involvement, at least 30% BM involvement by MCL (requiring transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] support) MCL patients may proceed with enrollment after discussion with the PI or Co-PI. Cytopenias may not be due to evidence of myelodysplastic syndrome (MDS) or hypoplastic BM.\n12. Adequate organ function as defined by the following laboratory values:\n\n    1. Creatinine clearance. \\>=30 mL\u002Fmin (by Cockcroft-Gault method, APPENDIX I),\n    2. Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and\u002For Gilbert's Disease or controlled immune hemolysis or considered an effect of regular blood transfusions.\n    3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN, or \\\u003C 5 x upper limit of normal if hepatic metastases are present.\n13. Projected life expectancy of \\>12 weeks pertaining to lymphoma.\n14. Female patients must be surgically sterile, postmenopausal (for at least 1 year), or have confirmed negative results for a pregnancy test at screening, on a blood or urine sample obtained within 7 days prior to initiation of study treatment.\n15. Women of childbearing potential and men with female partners of childbearing potential must be willing to use an effective form of contraception for at least 6 months after the last dose of study treatment. Patient enrolled into the Pirtobrutinib+ venetoclax study should use an effective form of contraception for 6 months after the last dose of Pirtobrutinib in combination with venetoclax, whichever time period is longer. Recommended methods of highly effective birth control are:\n\n    * Hormonal contraception (birth control pills, patches, or rings)\n    * Intrauterine device (IUD)\n    * Birth control injections\n    * Double barrier methods (diaphragm with spermicidal gel or condoms with birth control foam)\n    * Sterilization of participant or partner (\"tubes tied\" or vasectomy) Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \\[and 2 years of non-therapy-induced amenorrhea\\] or surgically sterile) to observe conventional and highly effective birth control methods with failure rates of \\\u003C 1% for the duration of treatment and for 6 months following the last dose of study treatment; this must include barrier methods such as condom or diaphragm with spermicidal gel. Women of reproductive potential are defined as following menarche and not postmenopausal (and 2 years of non-therapy-induced amenorrhea) or surgically sterile. For male subjects with a non-pregnant female partner of child-bearing potential and a woman of child-bearing potential one of the following highly effective birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended: Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or trans dermally, progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant, Intrauterine device (IUD) , Intrauterine hormone-releasing system (IUS), Bilateral tubal occlusion, Vasectomized partner, 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 lifestyle of the subject (CTFG 2014).\n\n    Birth control methods unacceptable for this clinical trial are:\n    1. Periodic abstinence (calendar, hypothermal, or post-ovulation methods)\n    2. Withdrawal (coitus interruptus)\n    3. Spermicide only\n    4. Lactational amenorrhea method • Sperm donation is prohibited during the duration of participation on this protocol and for 6 months after the last dose of any study drug.\n16. Patients are required to have the following washout periods prior to planned Cycle 1 Day 1 (C1D1).\n\n    * Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter\n    * Immunoconjugates antibody treatment within 10 weeks prior to enrollment.\n    * Broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 28 days prior to study enrollment\n    * Palliative limited field radiation must be completed 7 days prior to study enrollment. Note: In the case of known central nervous system (CNS) involvement by systemic lymphoma: Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease may be eligible if a compelling clinical rationale is provided by the Investigator and with documented IND sponsor's approval.\n17. Prior treatment-related AEs must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n\nExclusion Criteria:\n\n1. Known central nervous system (CNS) involvement by lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of disease (as shown by MRI brain and\u002For CSF or clinical exam by neurologists may be eligible if a compelling clinical rationale is provided to institutional IND sponsor contact.)\n2. History of bleeding diathesis\n3. History of stroke or intracranial hemorrhage within 6 months of C1D1\n4. Vaccination with live vaccine within 28 days prior to enrollment.\n5. Have a known hypersensitivity to any of the excipients of Pirtobrutinib or to the intended covalent BTK inhibitor if randomized to control arm.\n6. Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).\n7. Pregnant or lactating females.\n8. Known and uncontrolled HIV infection. Participants with HIV (known HIV 1\u002F2 antibodies positive) are allowed if all of the following conditions are met:\n\n   * CD4+ T-cell counts ≥350 cells\u002FμL;\n   * Participants with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections may be eligible, if they have not had an opportunistic infection within the past 12 months;\n   * If participant is on antiretroviral, evaluation of the specific agents must be performed in order to determine if participant is eligible (e.g., excluding patients taking strong CYP3A inhibitors such as ritonavir). If necessary, evaluate the feasibility of switching to an alternate effective ARV therapy (ART) regimen before study participation. Participants need to be on established ART for at least 4 weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n   * Screening for HIV infection is not required\n9. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below: Hepatitis B virus (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 enrollment. Patients who are hepatitis B PCR positive will be excluded. 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 enrollment. Patients who are hepatitis C RNA positive will be excluded.\n10. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and IND sponsor may pose a risk for patient participation. Screening for chronic conditions is not required.\n11. Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment\n12. Significant cardiovascular disease defined as:\n\n    * unstable angina or acute coronary syndrome within the past 2 months prior to enrollment\n    * history of myocardial infarction within 3 months prior to enrollment or\n    * documented LVEF by any method of ≤ 40% in the 12 months prior to enrollment\n    * ≥ Grade 3 NYHA functional classification system of heart failure, uncontrolled or symptomatic arrhythmias\n13. Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec on at least 2\u002F3 consecutive electrocardiograms (ECGs), and mean QTcF \\> 470 msec on ECG, during Screening. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33).\n\n    * Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n    * Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.\n14. Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. Subjects with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g. cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer (not on active chemotherapy) are permitted. Active second malignancy unless in remission with life expectancy \\> 2 years. Examples include:\n\n    * a. Adequately treated no melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.\n    * b. Adequately treated cervical carcinoma in situ without current evidence of disease.\n    * c. Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy.\n    * d. Localized prostate cancer undergoing active surveillance.\n15. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of venetoclax.\n16. With known allergies to xanthine oxidase inhibitors and\u002For rasburicase.\n17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and\u002For would make the patient inappropriate for enrollment into this study.\n18. No concomitant anticancer therapies, immunotherapies, cellular, or radiotherapy. No major surgery within 4 weeks prior to first dose of study treatment. Washout period for chemotherapy is 14 days. Washout period for targeted agents is 2 weeks or 5 half-lives (t1\u002F2) (whichever is shorter). Washout period for antibody-based immunotherapies or cellular therapies is 4 weeks. Washout period for radiotherapy is 7 days (limited field) and 28 days (extended field that includes BM). Washout period must be completed prior to any treatment administration.\n19. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) is for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n20. Concomitant steroids for disease related pain control are allowed at any dose but must be discontinued prior to any study treatment initiation. Chronic use of corticosteroids is allowed up to 20 mg prednisone or equivalent daily for non-cancer related conditions at the time of study start.\n21. History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T cell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and\u002For CAR-T therapy timing: • active graft versus host disease (GVHD); • cytopenia from incomplete blood cell count recovery post-transplant; • need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy; • ongoing immunosuppressive therapy (\\> 20 mg prednisone or equivalent daily).\n22. Known neurologic disorder or residual neurologic toxicities that may put patients at increased risk of neurologic toxicity in the opinion of the investigator.\n23. Active uncontrolled systemic infection.\n24. Received an investigational agent within 2 weeks or within 5 T1\u002F2, whichever is shorter prior to the first dose of study treatment.\n25. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and\u002For strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy start or planned use during study participation is prohibited, • grapefruit or grapefruit products\n\n    * Seville oranges or products from Seville oranges\n    * star fruit\n26. Patients taking warfarin and\u002For equivalent vitamin K antagonists are excluded since the use of these agents is contraindicated with Pirtobrutinib or with venetoclax.",{"count":613,"type":21},30,[138],"To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).",[27,617,592],"Non Hodgkin Lymphoma","2026-04-30",{"date":620,"type":39},"2026-05-05",{"date":622,"type":39},"2023-01-25",{"date":624,"type":21},"2027-04-28",{"name":626,"class":94},"M.D. Anderson Cancer Center",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":430,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":22,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":127},"100536335","phase-2-phase-ii-study-of-pirtobrutinib-rituximab-pr-in-previously-untreated-low-and-intermediate-risk-mcl-mantle-cell-lymphoma-patients-100536335","NCT06263491","Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients","Inclusion Criteria:\n\nThe study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment.\n\n1. Age ≥ 18 years old\n2. Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC.\n3. Newly diagnosed MCL with no prior therapy for MCL (age \\>= 18 years)\n\n   • Low risk - Ki-67% (\\\u003C= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \\\u003C= 3 cm.\n   * Medium risk - Ki-67% (\\\u003C=50%), largest tumor size \\\u003C=5 cm, no features of high-risk disease (see below in exclusion)\n4. Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, anti-hypertensive, prior ablation, anti-arrhythmia, prior arrhythmias, baseline EKG abnormalities and cardiology clearance are allowed. Ejection fraction \\>=50% and cardiology evaluation may be needed. (Echo and EKG and cardiology consultation within 2 months prior to C1D1 are allowed).\n5. Understand and voluntarily sign an IRB-approved informed consent form.\n6. Participants may have at least 1 site of radiographically assessable disease (i.e., lymph node longest diameter \\[LDi\\] \\>= 1.5 cm, not necessary for disease assessable by positron emission tomography \\[PET\\]\u002Fcomputerized tomography \\[CT\\], extra nodal site \\>= 1.0 cm in LDi. But participants with isolated gastrointestinal, bone marrow or spleen only disease patients are allowed.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (See Appendix III).\n8. Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (participants with an elevated prothrombin time and known lupus anticoagulant may be eligible for participation after consulting the study PI).\n\n9A. Adequate BM function independent of growth factor or PRBC or platelet transfusion support (within 14 days of Screening assessment and criteria must be met on C1D1 without transfusion\u002FG-CSF within 7 days of assessment, per local laboratory reference range at screening as follows:\n\na. platelet count \\>=75,000\u002Fmm3; b. absolute neutrophil count (ANC) \\>= 1000\u002Fmm3 unless cytopenia is clearly due to marrow involvement from MCL c. total hemoglobin \\>= 8 g\u002FdL (without transfusion support within 2 weeks of screening); If any of the above-mentioned cytopenias (a-c) are present due to significant BM involvement, at least 30% BM involvement by MCL (requiring transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] support) MCL patients may proceed with enrollment after discussion with the PI or Co-PI. Cytopenias may not be due to evidence of myelodysplastic syndrome (MDS) or hypoplastic BM.\n\n9B. Adequate organ function as defined by the following laboratory values:\n\na. Creatinine clearance. \\>=30 mL\u002Fmin (by Cockcroft-Gault method, APPENDIX I), b. Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and\u002For Gilbert's Disease or controlled immune hemolysis or considered an effect of regular blood transfusions.\n\nc. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 x ULN, or \\\u003C 5 x upper limit of normal if hepatic metastases are present.\n\n10\\. Projected life expectancy of \\>12 weeks pertaining to lymphoma. 11. Female participants must be surgically sterile, postmenopausal (for at least 1 year), or have confirmed negative results for a pregnancy test at screening, on a serum sample obtained within 7 days prior to initiation of study treatment.\n\n12\\. Women of childbearing potential and men with female partners of childbearing potential must be willing to use a highly effective form of contraception for at least 1 month after the last dose of study treatment. Participant enrolled into the Pirtobrutinib+ rituximab study should use a highly effective form of contraception for 1 month after the last dose of Pirtobrutinib and 12 months after the last dose of rituximab, whichever time period is longer. Recommended methods of highly effective birth control are:\n\n1. Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n2. Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n3. Intrauterine device (IUD)\n4. Intrauterine hormone-releasing system (IUS)\n5. Vasectomized partner\n6. 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 participant.\n7. Female sterilization\n8. Fallopian tube implants (if confirmed by hysterosalpingogram) 13. Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of Pirtobrutinib.\n\nExclusion Criteria:\n\n1. Participants with central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML) are excluded since those participants have very poor prognosis, need aggressive intensive chemoimmunotherapy and intrathecal chemotherapy along with BTK inhibitors and these participants would not be eligible for this study.\n2. High risk MCL - any or all of the following (Blastoid\u002Fpleomorphic histology), High Ki-67 (\\>50%), Bulky disease (nodes \\>5 cm, spleen \\>20 cm), lymphocytosis \\>=50,000 cells\u002FuL, TP53 mutated or del17p by FISH. Presence of MYC rearrangement positive by FISH or MYC, Bcl2 amplification, complex karyotype or high-risk biologic MIPI (with Ki-67%)\n3. Major surgery within 4 weeks prior to registration\n4. History of bleeding diathesis\n5. Known active CMV. Unknown or negative status are eligible\n6. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for participant participation. Screening for chronic conditions is not required\n7. Clinically significant cardiovascular diseases as determined after cardiology consultation, including uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or any Class 3 (moderate) or 4 (severe) cardiac disease following the New York Heart Association Classification. Otherwise, significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, or QTc \\>470 msec.\n8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n9. Pregnancy or plan to become pregnant during the study or within 1-month post pirtobrutinib or 12 months post Rituxan. (Note: post rituxan, WOCBP should not become pregnant for 12 months post last dose of rituxan).\n10. Lactation during the study or for 1 week after last dose of pirtobrutinib (Note that the USPI for rituxan recommends no lactation during treatment and for 6 months after last dose)\n11. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and\u002For strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy start or planned use during study participation is prohibited - grapefruit or grapefruit products, Seville oranges or products from Seville oranges, star fruit\n12. Participants taking warfarin and\u002For equivalent vitamin K antagonists\n13. Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.\n14. History of stroke or intracranial hemorrhage within 6 months of C1D1\n15. Vaccination with live vaccine within 28 days prior to enrollment.\n16. Have a known hypersensitivity to any of the excipients of Pirtobrutinib or rituximab\n17. Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).\n18. Participants who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK-inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment\n19. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below: Hepatitis B virus (HBV): Participants 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 enrollment. Participants who are hepatitis B PCR positive will be excluded unless cleared by infectious disease. If a participant is Hep B core antibody positive, they must be on an approved nucleos(T)ide analogue to help prevent reactivation. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, participant will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment, unless cleared by infectious disease. Participants who are hepatitis C RNA positive will be excluded.\n20. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral including CMV, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and IND sponsor may pose a risk for patient participation. Screening for chronic conditions is not required.\n21. Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec on one electrocardiograms (ECGs), during Screening. EKG might be repeated same day to check for any physiologic variation. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33).\n22. Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n23. Correction for underlying bundle branch block (BBB) allowed. Note: Participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.\n24. Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. Subjects with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g. cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer (not on active chemotherapy) are permitted. Active second malignancy unless in remission with life expectancy \\> 1 years. Examples include:\n\n    1. Adequately treated no melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.\n    2. Adequately treated cervical carcinoma in situ without current evidence of disease.\n    3. Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy.\n    4. Localized prostate cancer undergoing hormonal therapy.\n25. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n26. With known allergies to xanthine oxidase inhibitors and\u002For rasburicase.\n27. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and\u002For would make the participant inappropriate for enrollment into this study.\n28. No concomitant anticancer therapies, immunotherapies, cellular, or radiotherapy. No major surgery within 4 weeks prior to first dose of study treatment.\n29. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) is for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n30. Concomitant steroids for disease related pain control are allowed at any dose but must be discontinued prior to any study treatment initiation. Chronic use of corticosteroids is allowed up to 20 mg prednisone or equivalent daily for non-cancer related conditions at the time of study start.\n31. History of GVHD, allogeneic HSCT transplant, allogeneic organ transplant\n32. Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active\u002Fsymptomatic coronary artery disease, COPD, renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that places the participant at unacceptable risk and would prevent the subject from signing the informed consent form.",{"count":634,"type":21},50,[138],"To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.",[27],"2026-04-22",{"date":640,"type":39},"2026-04-23",{"date":642,"type":39},"2024-05-29",{"date":644,"type":21},"2027-03-01",{"name":626,"class":94},{"id":647,"slug":648,"hasResults":12,"nctId":649,"briefTitle":650,"officialTitle":651,"acronym":4,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":17,"minAge":79,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":655,"briefSummary":656,"conditions":657,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":662,"locationsCount":127},"100458133","phase-2-a-study-comparing-rituximabbendamustinrb-alternating-with-rituximabbendamustincytarabinrbac-with-rb-therapy-in-elderly-patients-with-mentle-cell-lymphoma-100458133","NCT05245656","A Study Comparing Rituximab\u002FBendamustin(RB) Alternating With Rituximab\u002FBendamustin\u002FCytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma","A Randomized Phase II Trial Comparing Rituximab\u002FBendamustine(RB) Alternating With Rituximab\u002FBendamustine\u002FCytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria\n2. age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.\n3. ECOG performance status 2 or less\n4. Adequate organ functions\n\n   * adequate heart function: LVEF ≥50% by echocardiography or MUGA\n   * adequate renal function: serum creatinine ≤ 2.0mg\u002FdL or CrCl ≥40 mL\u002Fmin based on the Cockcroft-Gault method\n   * adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)\n   * adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500\u002FmL, platelet counts ≥ 100,000\u002FmL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. In-situ mantle cell lymphoma\n2. Ann Arbor stage 1 disease\n3. Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.\n4. Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,\n5. Central nervous system involvement\n6. HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)\n7. History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)\n8. Known history of human immunodeficiency virus (HIV) infection\n9. any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his\u002Fher compliance in the study\n\n   * Congestive heart failure ≥ NYHA class 3\n   * Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)\n   * History of significant neurological or psychological disorder including dementia and seizure disorder\n   * Severe chronic obstructive pulmonary disease with hypoxemia\n   * Cerebrovascular disease including transient ischemic attack within the past 6 months\n   * Non-healing wound, ulcer, or bone fracture\n   * Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n10. concomitant administration of any other experimental drugs under investigation\n11. Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol\n12. major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment\n13. If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers \\[diaphragm, cervical cap\\] in the patient's partner and the use of condoms in men) when sexually active.",{"count":654,"type":21},90,[138],"This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab\u002Fbendamustine (RB) alternating with rituximab\u002Fbendamustine\u002Fcytarabine (RBAC) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.",[27],{"date":640,"type":39},{"date":660,"type":39},"2022-10-18",{"date":419,"type":21},{"name":663,"class":94},"Kim, Seok Jin",{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":127},"100580573","phase-2-sonrotoclax-rituximab-and-zanubrutinib-in-treating-participants-with-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-and-mantle-cell-lymphoma-100580573","NCT06839053","Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma","SONIC: Escalated Inpatient Ramp-Up of Sonrotoclax in Patients With Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Mantle Cell Lymphoma (MCL) (SONIC Study)","Inclusion Criteria:\n\n* Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or analyses\n* Age 18 years or older\n* Confirmed diagnosis (per World Health Organization \\[WHO\\] guidelines, unless otherwise noted) of one of the following:\n\n  * CLL\u002FSLL COHORT: CLL\u002FSLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria:\n\n    * Meeting the following sets of prior treatment criteria:\n\n      * For the R\u002FR cohort, disease that relapsed after, or was refractory to, at least 1 prior therapy\n      * For the treatment-naïve cohort, patients should have no prior treatment for CLL\u002FSLL (other than 1 aborted regimen \\\u003C 2 weeks in duration and \\> 4 weeks before enrollment)\n    * Requiring treatment per International Workshop on CLL (iwCLL) criteria\n  * MCL COHORT: WHO-defined MCL\n\n    * R\u002FR MCL is defined as a disease that relapsed after, or was refractory to, at least 1 prior systemic therapy\n* Measurable disease, defined as:\n\n  * CLL\u002FSLL: at least 1 lymph node \\> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) or clonal lymphocytes \\>= 5 x 109\u002FL present on peripheral blood flow cytometry\n  * MCL, or SLL: at least 1 lymph node \\> 1.5 cm in the longest diameter OR 1 extranodal lesion \\> 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions by CT\u002FMRI\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Absolute neutrophil count (ANC) \\>= 1.0 x 10\\^9\u002FL =\\\u003C 7 days before the first dose of the study drug with or without growth factor support. There is an exception for patients with bone marrow involvement, in which case ANC must be \\>= 0.75 x 10\\^9\u002FL before the first dose of the study drug\n* Platelets \\> 75,000 x 10\\^9\u002FL (\\> 75,000 cells\u002Fmm\\^3) =\\\u003C 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions. Patients with bone marrow involvement will be allowed to have a platelet count \\> 50,000 x 10\\^9\u002FL (\\> 50,000 cells\u002Fmm\\^3) =\\\u003C 7 days before the first dose of the study drug without the use of growth factor support or platelet transfusions\n* Hemoglobin \\> 75 g\u002FL =\\\u003C 7 days before the first dose of the study drug (with or without transfusion)\n* Creatinine clearance or glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin as estimated by one of the following:\n\n  * Cockcroft-Gault equation\n  * Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n  * 24-hour urine collection\n* Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase =\\\u003C 2 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase =\\\u003C 2 x ULN\n* Total bilirubin level =\\\u003C 1.5 x ULN (unless documented Gilbert's syndrome). For patients with documented Gilbert's syndrome, total bilirubin may exceed this value, but direct bilirubin must be =\\\u003C 1.0 x ULN\n* Serum amylase =\\\u003C 1.5 x ULN\n* Serum lipase =\\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test =\\\u003C 7 days before the first dose of the study drug. In addition, they must use a highly effective method of birth control initiated before the first dose of the study drug, for the duration of the study treatment period, and for \\>= 180 days after the last dose of the study drug\n\n  * NOTE: WOCBP is a woman who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months)\n  * NOTE: Highly effective contraceptive methods include the following:\n\n    * Combined (estrogen and progestogen-containing) hormonal contraception associated with the inhibition of ovulation. Combined hormonal contraception may be oral, intravaginal, or transdermal\n\n      * Progestogen-only hormonal contraception associated with the inhibition of ovulation. Progesterone-only hormonal contraception may be oral, injectable, or implantable\n      * An intrauterine device\n      * Intrauterine hormone-releasing system\n      * Bilateral tubal\n    * Vasectomized partner\n\n      * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment, starting the day before the first dose of study treatment, for the duration of the study, and for \\>= 180 days after the last dose of study drug. Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to investigational medicinal product, and withdrawal are not acceptable methods of contraception\n  * Of note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception, and, if used, this method must be used in combination with another acceptable method listed above\n  * For patients using hormonal contraceptives such as birth control pills or devices, a second barrier method of contraception (e.g., condoms) must be used\n* Nonsterile men must use a highly effective method of birth control along with barrier contraception for the duration of the study treatment period and for ≥ 180 days after the last dose of the study drug. During this same period, they must not donate sperm. Sterile men must use barrier contraception\n* Life expectancy of \\> 6 months\n* Able to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Exposure to a Bcl-2 inhibitor within the last 12 months or a history of disease progression while taking a Bcl-2 inhibitor\n* Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, melanoma, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score =\\\u003C 6 prostate cancer\n* Underlying medical conditions that may render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results\n* Known current central nervous system involvement by lymphoma\u002Fleukemia\n* Known plasma cell neoplasm other than a monoclonal gammopathy of undetermined significance (MGUS), prolymphocytic leukemia, or history of or currently suspected Richter's syndrome\n* Prior autologous stem cell transplant unless \\>= 3 months after transplant; or prior chimeric antigen receptor T-cell (CAR-T) therapy unless \\>= 3 months after cell infusion\n* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for the treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent\n* History of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention\n* Use of the following substances prior to the first dose of the study drug:\n\n  * =\\\u003C 28 days before the first dose of the study drug:\n\n    * Any biologic and\u002For immunologic-based therapy(ies) including experimental therapy(ies) for leukemia, lymphoma, or myeloma (including, but not limited to, monoclonal antibody therapy, e.g., rituximab, and\u002For cancer vaccine therapy). If biological and\u002For immunologic-based therapy(ies) are used for non-oncological indications, enrollment will be at the discretion of the principal investigator (PI)\n  * =\\\u003C 14 days before the first dose of the study drug:\n\n    * Systemic chemotherapy or radiation therapy\n  * =\\\u003C 7 days before the first dose of the study drug:\n\n    * Corticosteroid given with antineoplastic intent\n  * =\\\u003C 3 days (or 5 half-lives; whichever is shorter) before the first dose of the study drug:\n\n    * Bruton's tyrosine kinase inhibitor (BTKi) or other small molecule inhibitor is given with antineoplastic intent\n* Active fungal, bacterial, and\u002For viral infection requiring systemic therapy\n\n  * Note: oral antibiotics for minor bacterial infections are allowed\n* Major surgery =\\\u003C 4 weeks before the first dose of study treatment\n* Toxicity from prior anticancer therapy that has not recovered to grade =\\\u003C 1 (except for alopecia, ANC, and platelet count; for ANC and platelet count)\n* Clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction =\\\u003C 6 months before screening\n  * Unstable angina =\\\u003C 3 months before screening\n  * New York Heart Association class III or IV congestive heart failure\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n  * Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n  * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements, at screening, showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg\n* Known infection with human immunodeficiency virus (HIV) or serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:\n\n  * Presence of viral hepatitis B surface antigen (HBsAg) or viral hepatitis B core antibody (HBcAb)\n\n    * Note: Patients with the presence of HBcAb, but absence of HBsAg, are eligible if HBV deoxyribonucleic acid (DNA) is undetectable and if they are willing to take HBV reactivation prophylaxis and undergo monitoring for HBV reactivation\n  * Presence of HCV antibody\n\n    * Note: Patients with the presence of HCV antibody are eligible if HCV ribonucleic acid (RNA) is undetectable and if they are willing to undergo monitoring for HCV reactivation\n* Pregnant or lactating women\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedure, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Inability to comply with study procedures\n* Receiving any treatment with a strong or moderate CYP3A4 inhibitor =\\\u003C 14 days (or 5 half-lives, whichever is longer) before the first dose of sonrotoclax\n* Unwillingness to stop consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before the first dose of sonrotoclax or during the study\n* Receiving any treatment with a strong CYP3A4 inducer =\\\u003C 14 days (or 5 half-lives, whichever is longer) before first dose of sonrotoclax\n* History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis and acute lung diseases\n* Autoimmune anemia and\u002For thrombocytopenia that is poorly controlled by corticosteroids or other standard therapy\n* Ongoing, drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension\n* Receiving drugs known to prolong the QT\u002Fcorrected QT (QTc) interval\n* Vaccination with a live vaccine =\\\u003C 35 days before the first dose of the study drug\n\n  * Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed",{"count":613,"type":21},[138],"This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is newly diagnosed, has come back after a period of improvement (relapsed) or does not respond to treatment (refractory). Rituximab is a monoclonal antibody that binds to a protein called CD20, which is found on B-cells, and may kill tumor cells. Zanubrutinib may stop the growth of tumor cells by blocking a protein called Bruton's tyrosine kinase (BTK), which is needed for tumor cell growth. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (BCL-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. Giving an increased dose of sonrotoclax over a shorter period of time in combination with zanubrutinib or rituximab may be safe and tolerable in treating patients with newly diagnosed, relapsed or refractory CLL, SLL, and MCL.",[177,27,675,676,677,444,678,447,178],"Recurrent Chronic Lymphocytic Leukemia","Recurrent Mantle Cell Lymphoma","Recurrent Small Lymphocytic Lymphoma","Refractory Mantle Cell Lymphoma","2026-04-17",{"date":638,"type":39},{"date":682,"type":39},"2025-06-02",{"date":684,"type":21},"2032-07-01",{"name":456,"class":94},{"id":687,"slug":688,"hasResults":12,"nctId":689,"briefTitle":690,"officialTitle":691,"acronym":4,"eligibilityCriteria":692,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":22,"phases":695,"briefSummary":696,"conditions":697,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":698,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":705},"100325973","phase-1-venetoclax-lenalidomide-and-rituximab-in-patients-with-previously-untreated-mantle-cell-lymphoma-100325973","NCT03523975","Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma","Phase I\u002FII Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment\n* Laboratory, radiographic, physical exam findings and\u002For symptoms attributable to MCL\n* ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2\n* All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program\n* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.\n* Men and Women of childbearing potential on appropriate contraception\n* Adequate organ function\n* Ability to understand and the willingness to sign a written informed consent.\n* Ability to swallow oral capsules\u002Ftablets\n\nExclusion Criteria:\n\n* Prior treatment for MCL with chemotherapy\n* Pregnant or breastfeeding women\n* Grade 2 or higher peripheral neuropathy\n* Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment\n* Significant cardiovascular disease\n* Any condition that might significantly impair drug absorption as determined by the investigator\n* Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug\n* History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug\n* Concurrent participation in another clinical trial\n* Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.\n* Psychiatric illness or social situations that would limit compliance with study requirements\n* Subject has known positivity to HIV\n* Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.\n* Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to\\\u003C 2 years.",{"count":694,"type":21},28,[58,138],"The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).",[27],{"date":638,"type":39},{"date":700,"type":39},"2018-12-24",{"date":702,"type":21},"2027-06-24",{"name":704,"class":94},"City of Hope Medical Center",4]