[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,58,82,111,149,177,209,233,261,293,325,351,372,398,433,480,509,530,553,583,605,632,652,678,722],{"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":26,"conditions":27,"keywords":37,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905",false,"NCT05294731","Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies","Key Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any study\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria\n4. Phase 1: Confirmed diagnosis of R\u002FR Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL\u002FSLL\n5. Phase 2: Confirmed diagnosis of MCL, or CLL\u002FSLL\n6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug\n\nKey Exclusion Criteria\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer\n2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment\n3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.\n4. Current or history of central nervous involvement\n5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years",{"count":20,"type":21},146,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts",[28,29,30,31,32,33,34,35,36],"B-cell Malignancy","Non-Hodgkin Lymphoma","Mantle Cell Lymphoma","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","Waldenström Macroglobulinemia","Marginal Zone Lymphoma","Follicular Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[28,38,39,40,36,41,42,43,44],"MZL","FL","DLBCL","CDAC","BTK","degrader","BGB-16673","RECRUITING","2026-08-20",{"date":48,"type":49},"2026-08-21","ACTUAL",{"date":51,"type":49},"2022-05-06",{"date":53,"type":21},"2029-01-31",{"name":55,"class":56},"BeiGene","INDUSTRY",29,{"id":59,"slug":60,"hasResults":12,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"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 Tacabrutideg (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":67,"type":21},645,[24,25],"Study consists of two main parts to explore tacabrutideg 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)",[28,33,34,29,32,71,72,30,73],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Diffuse Large B Cell Lymphoma",{"date":48,"type":49},{"date":76,"type":49},"2021-09-13",{"date":78,"type":21},"2029-11",{"name":80,"class":56},"BeOne Medicines",115,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100573185","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-100573185","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.",{"count":90,"type":21},300,[92],"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.",[30,95],"B Cell Lymphoma",[97,98,99,100,101],"mantle cell lymphoma","MCL","relapsed\u002Frefractory mantle cell lymphoma","sonrotoclax","BGB-11417","2026-08-17",{"date":104,"type":49},"2026-08-19",{"date":106,"type":49},"2025-03-05",{"date":108,"type":21},"2032-03-30",{"name":80,"class":56},155,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"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":120,"type":21},408,[24,25],"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",[124,72,125,126,127],"Chronic Lymphocytic Leukaemia","Mantle-cell Lymphoma","Large B-cell Lymphoma","B-cell Non-Hodgkin Lymphoma",[129,130,131,132,133,134,135,136,137,138],"IgG4 fully human CD19xCD3 bispecific T-cell engager","B cell lymphoma","Subcutaneous","Acalabrutinib","Prednisone","Rituximab","Cyclophosphamide","Vincristine","Doxorubicin","Surovatamig","2026-08-11",{"date":141,"type":49},"2026-08-12",{"date":143,"type":49},"2025-01-30",{"date":145,"type":21},"2029-06-11",{"name":147,"class":56},"AstraZeneca",64,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":176},"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":157,"type":21},40,[25],"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.",[30],[162,163,164,165,166],"CAR-T","Relapsed","Refractory","BTK inhibitor","BCL2 inhibitor","2026-08-10",{"date":139,"type":49},{"date":170,"type":21},"2026-08-31",{"date":172,"type":21},"2030-12-31",{"name":174,"class":175},"Canadian Cancer Trials Group","NETWORK",3,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":208},"100542274","phase-1-autologouscd22-chimeric-antigen-receptor-cart-cells-in-wrecurrentrefractory-b-cell-lymphomas-100542274","NCT06340737","AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w\u002FRecurrent\u002FRefractory B Cell Lymphomas","Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas","Inclusion Criteria:\n\n* Disease: Must have histologically confirmed disease as defined by WHO 2016\\[117\\] of one of the following:\n\nFollicular Lymphoma, grade 1-3a\n\n1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.\n2. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.\n\nMantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.\n\n2\\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.\n\nHairy cell leukemia (HCL)\n\n1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \\\u003C11 g\u002FdL), thrombocytopenia (platelets\\\u003C100 x 10\\^9 \u002FL), or neutropenia (absolute neutrophil count below 1.5 x 10\\^9\u002FL); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;\n2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.\n\nLymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed\n\n1\\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy\n\n1\\. Prior therapies must include a i. BTKi ii. either chemotherapy and\u002For proteasome inhibitor 3. Requires treatment based on the recommendations from the Second International Workshop on WM 4. Requires the presence of serum IgM that is at least 2 times the upper limit of normal 5. Patients cannot require plasmapheresis for symptomatic hyperviscosity. 6. Patients cannot have symptomatic central nervous system involvement (Bing-Neel syndrome) that would prevent the assessment of neurotoxicity 7. Patients cannot have transformed to large B cell lymphoma Burkitt lymphoma (BL)\n\n1\\. Relapsed or refractory to front line chemoimmunotherapy; Participants with high-grade B-cell lymphoma with MYC and BCL2 and\u002ForBCL6 rearrangements will be excluded.\n\nMarginal zone lymphoma (MZL)\n\n1\\. Must have received 2 prior lines of therapy including rituximab in combination with chemotherapy or a BTKi\n\nHistologically confirmed Large B-cell lymphoma (LBCL) by WHO 2008 including:\n\ni. DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR ii. primary mediastinal (thymic) large B cell lymphoma; OR iii. transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma to DLBCL; OR iv. Follicular Lymphoma Grade 3B\n\n• Subjects with DLBCL, Follicular Lymphoma Grade 3B -or-\n\nSubjects with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation:\n\n1\\) Must have received an anthracycline regimen and an anti CD20 monoclonal antibody (unless documented CD20-negative) and be refractory or relapsed after second line of LBCL treatment. Subjects with a partial response to second line therapy must be ineligible for autologous transplant.\n\n* Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:\n\n  1. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL\n\n     Note: T cell\u002Fhistiocyte rich large B cell lymphoma is not eligible\n\n     The following criteria apply to all participants unless otherwise noted:\n\n  2\\. Measurable Disease:\n  1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\n     b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible\n  2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.\n  3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.\n\n  3\\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.\n\n  4\\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.\n\n  5\\. Meet required prior therapy washout windows prior to leukapheresis (see inclusion criteria for leukapheresis for details).\n\n  6\\. Participants with prior CAR therapy must be at least 30 days post CAR infusion and have \\\u003C 5% CD3+ cells express the previous CAR prior to apheresis, if a validated assay is available.\n\n  7\\. Toxicities from prior therapy stable or resolved (except for clinically non-significant toxicity and cytopenias covered in footnote).\n\n  8\\. Age ≥ 18 years of age. 9. Adequate performance status (ECOG 0, 1, or 2; or Karnofsky \\> 60%) 10. Adequate organ and marrow function as defined by:\n\n  \\- ANC ≥ 750\u002FuL\n  * Platelet count ≥ 50,000\u002FuL\n  * ALC ≥ 150\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \\\u003C 2 mg\u002FdL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg\u002Fdl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air ANC Platelet ALC Cr CreatCl AST\u002FALT Bilirubin LVEF O2 Sat\n  * 11\\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.\n\n    14\\. Must be able to provide informed consent (LAR is permitted if participant able to provide verbal assent).\n\nA participant will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n* Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n\n  2\\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety\n\n  3\\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.\n\n  4\\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and\u002For nucleic acid testing.\n\n  5\\. Active cerebrovascular ischemic\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.\n\n  6\\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.\n\n  7\\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n\n  8\\. Is pregnant or breastfeeding.\n\n  9\\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n\n  10\\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, or be likely to complete all protocol-required visits and procedures.",{"count":185,"type":21},148,[24],"This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed \u002F refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.",[34,30,189,190,191,33,192,126],"Hairy Cell Leukemia","Lymphoplasmacytic Lymphoma","Burkitt Lymphoma","Waldenstrom Macroglobulinemia",[194,195,196,197,198,199],"lymphoma","leukemia","lymphodepleting chemotherapy","relapsed","refractory","systemic therapy",{"date":141,"type":49},{"date":202,"type":49},"2024-03-29",{"date":204,"type":21},"2031-04",{"name":206,"class":207},"Stanford University","OTHER",1,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100569664","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":217,"type":21},258,[24,25],"The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[71,221,30,98],"CLL",[223,224],"CLL previously untreated","Hematological Malignancies","2026-08-06",{"date":167,"type":49},{"date":228,"type":49},"2025-01-23",{"date":230,"type":21},"2032-11-30",{"name":80,"class":56},17,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":208},"100507421","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":242,"type":21},20,[24],"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.",[246,126,247,30,248,73],"Hematologic Malignancy","Acute Lymphoblastic Leukemia","Multiple Myeloma",[250,251,252,253],"CAR T-cell therapy","autologous hematopoietic stem cells","CAR T","CAR T therapy",{"date":167,"type":49},{"date":256,"type":49},"2024-03-02",{"date":258,"type":21},"2027-12-15",{"name":260,"class":207},"Joshua Sasine, MD, PhD",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":267,"enrollmentInfo":268,"targetDuration":4,"studyType":270,"phases":4,"briefSummary":271,"conditions":272,"keywords":278,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":208},"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":269,"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.",[273,274,30,275,276,277],"Chronic Lymphocytic Leukemia (CLL)","Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia","Sudden Cardiac Death","Cardiac Arrhythmias","Hematologic Malignancies",[279,273,280,281,282,283],"SUDDEN CARDIAC DEATH","Ibrutinib Treatment","Atrial Fibrillation\u002FFlutter","Ventricular Arrhythmias","Natural History",{"date":285,"type":49},"2026-08-07",{"date":287,"type":49},"2023-03-01",{"date":289,"type":21},"2027-04-08",{"name":291,"class":292},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":300,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":312,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":303,"type":21},32,[24,25],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[307,126,71,72,33,34,30,73,308,191,309,310,311],"B-cell Acute Lymphoblastic Leukemia","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[313,314,315],"CD19-positive","Leukemia","Lymphoma","2026-08-04",{"date":225,"type":49},{"date":319,"type":49},"2025-05-30",{"date":321,"type":21},"2031-09",{"name":323,"class":56},"Vironexis Biotherapeutics Inc.",11,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":338,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":208},"100515358","phase-1-lv2019-car-t-cells-in-combination-with-pirtobrutinib-for-relapsed-refractory-b-cell-malignancies-100515358","NCT05990465","LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies","To facilitate rapid start of pirtobrutinib, there will be separate inclusion\u002Fexclusion for pirtobrutinib and LV20.19 CAR T-cells in addition to the general inclusion as outlined below.\n\nGeneral inclusion criteria for trial:\n\n1. Patients must be aged ≥18 years and \\\u003C81 years with relapsed or refractory B-cell non-Hodgkin Lymphoma (NHL).\n2. Diagnosis of relapsed or refractory B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, Burkitt Lymphoma and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV)+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n3. Disease specific criteria as follows:\n\n   1. DLBCL and associated subtypes (listed above)\n\n   i. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody with combination anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma or early relapse ≤6 months after one line of therapy.\n2. For relapse \\>6.00 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\nii. Relapse post-autologous transplant. iii. Relapse post-allogeneic transplant. iv. Relapse post-CAR T-cell therapy (maximum 2 patients allowed with this designation).\n\nb. Mantle Cell Lymphoma\n\ni. Must have received Rituximab or another CD 20 antibody with one chemotherapy regimen appropriate for this disease (bendamustine or cytarabine, or anthracycline based treatment) and have ONE of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line BTK inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n\n   c. Marginal Zone Lymphoma and Follicular Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody with chemotherapy regimen appropriate for the disease and have ONE of the following:\n\n\u003C!-- -->\n\n1. Relapsed disease after two lines of therapy including administration of anti-CD20 antibody.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n\n   d. Burkitt's Lymphoma\n\n   i. Must have received Rituximab or another CD20 antibody in combination with anthracycline based chemotherapy regimen and have ONE of the following:\n\n\u003C!-- -->\n\n1. Primary refractory lymphoma.\n2. Relapse within 6 months.\n3. For relapse \\>6 months, failure of two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n\n   i. Relapse post-autologous transplant. ii. Relapse post-allogeneic transplant.\n4. Able to provide written informed consent.\n5. Negative urine or serum pregnancy test in females of childbearing potential at screening.\n6. Willingness of women of reproductive potential and their partners to observe highly effective birth control methods for duration of treatment and for 1 month following the last dose if study treatment.\n7. Karnofsky performance score ≥70.\n8. Expected survival \\>12 weeks.\n9. Patient has demonstrated compliance with prior therapies.\n10. Able to take oral medications.\n11. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x upper limit of normal (ULN).\n12. Patients are required to have the following washout periods prior to planned Cycle 1 Day 1 (C1D1). In addition, prior treatment-related adverse events (AEs) must have recovered to Grade ≤ 1 with the exception of alopecia and Grade 2 peripheral neuropathy.\n\n    1. Targeted agents, investigational agents, therapeutic monoclonal antibodies or cytotoxic chemotherapy: 5 half-lives or 2 weeks, whichever is shorter.\n    2. immunoconjugated antibody treatment within 10 weeks prior to randomization.\n    3. broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) must be completed 14 days prior to study enrollment.\n    4. palliative limited field radiation must be completed 7 days prior to study enrollment.\n\nInclusion Criteria to START Pirtobrutinib Bridging:\n\n1. Absolute neutrophil count (ANC) ≥1000 with no G-CSF within 7 days or pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n2. Platelets≥50,000 with no transfusion within 7 days unless patient has biopsy proven bone marrow involvement.\n3. Hemoglobin ≥8g\u002FdL (≥80 g\u002FL) \\[blood transfusions are allowable to reach this goal\\].\n4. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C3 x upper limit of normal (ULN) or \\\u003C 5 x ULN with documented liver involvement; serum bilirubin \\\u003C1.5 x ULN or \\\u003C3 x ULN with documented liver involvement , or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n5. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin.\n\n   1. No IV hydration within 24 hours of eligibility.\n   2. No dialysis dependent renal failure.\n\nInclusion criteria for Pirtobrutinib Maintenance (part B)\n\n1. Recovery of neutrophils count after CAR T-cell infusion with ANC ≥1000\u002FdL without G-CSF within the last 7 days.\n2. Recovery of platelet count after CAR T-cell infusion with platelet count ≥50,000\u002FdL.\n3. Adequate hepatic function, defined as back to baseline or AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PI's discretion (e.g., Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n4. Adequate renal function, defined as creatinine clearance≥40 ml\u002Fmin.\n5. Evidence of response or stable disease (complete response\u002Fpartial response\u002Fstable disease) at day 28 after CAR T-cell therapy.\n\nInclusion Criteria for Apheresis and LV20.19 CAR T-cells:\n\n1. Active Measurable disease must be documented within 4 weeks of lymphodepletion start defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL.\n2. Absolute cluster of differentiation (CD) 3 count≥50 mm\\^3.\n3. MRI brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment.\n4. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by echocardiogram (ECHO) or MUGA) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n5. No contraindication to central line access.\n6. ANC≥1000 with no pegylated G-CSF within 14 days unless patient has biopsy proven bone marrow involvement.\n7. Platelets≥50,000 with no transfusion within 72 hours unless patient has biopsy proven bone marrow involvement.\n8. Adequate hepatic function, defined as AST and ALT \\\u003C3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C3 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n9. Adequate renal function, defined as creatinine clearance≥50 ml\u002Fmin. a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure.\n\nExclusion Criteria:\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential or plan to become pregnant during the study or within 1 month of the last dose of study treatment and women who are current lactating or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n2. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n   1. HBV: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before randomization. Patients who are hepatitis B PCR positive will be excluded.\n   2. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.\n3. Known active cytomegalovirus (CMV) infection (Unknown or negative status are eligible).\n4. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n5. Presence of ≥ grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n6. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n7. Refusal to participate in the long-term follow-up protocol.\n8. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture.\n\n   1. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n9. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n10. Prior allogeneic CAR T-cell therapy \\\u003C100 days from prior CAR T-cell treatment.\n11. Previous recipients of autologous CAR-T cell therapy directed at either cluster of differentiation 19 (CD19) or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec).\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry.\n12. Anti-CD20 antibody treatment within 4 weeks of cell infusion.\n13. Anti-CD19 antibody treatment within 4 weeks of cell infusion.\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells.\n15. No other oral chemotherapeutic agents or antibody directed treatment after starting pirtobrutinib other than steroids or radiation to a single site in a palliative fashion.\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias.\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002FFollicular lymphoma (FL) \u002F Marginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma\u002FRichter's.\n18. Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n19. History of stroke or intracranial hemorrhage within 6 months of randomization.\n20. Significant cardiovascular disease defined as myocardial infarction within 6 months of randomization, congestive heart failure with ejection fraction \\\u003C30%, active unstable angina, QT prolongation (QTcF)\\>470 msec on ECG.\n21. Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n22. Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n23. Patients who had surgery within 4 weeks prior to randomization.\n24. Patients who have received vaccination with live vaccine within 28 days prior to randomization.\n25. Patients with known hypersensitivity to any of the excipients of pirtobrutinib.\n\n    Special Criteria Regarding Fertility and Contraception\n\n    Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed at screening.\n\n    Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\n    Acceptable birth control includes a combination of two of the following methods:\n\n    • Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n\n    • Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n\n    • Intrauterine device (IUD)\n\n    • Intrauterine hormone-releasing system (IUS)\n\n    • Vasectomized partner\n\n    • Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence will be evaluated in relation to the duration of the study and to the usual lifestyles of the patient.\n\n    • Female sterilization\n\n    • Fallopian tube implants (if confirmed by hysterosalpingogram) Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of study drug.\n\n    Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months which is non-therapy induced or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.","81 Years",{"count":334,"type":21},12,[24],"This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.",[310,73,34,33,30,191],[162,339,340,341,342,165,343],"Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","Bruton's tyrosine kinase",{"date":225,"type":49},{"date":346,"type":49},"2025-02-06",{"date":348,"type":21},"2030-07",{"name":350,"class":207},"Medical College of Wisconsin",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"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 evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization \\[FISH\\], polymerase chain reaction \\[PCR\\]\u002Fsequencing, karyotype). Patients with cyclin D1 and\u002For t(11;14) negative mantle cell lymphoma with an expression profile suggesting a diagnosis of mantle cell lymphoma \\[MCL\\] such as SOX11 expression are also eligible\n\n  * Any stage allowed (stage I-IV)\n\n    * Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the only site of lymphoma OR bone marrow involvement by MCL\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 prior to registration\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 if thrombocytopenia is due to 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  * Known QT correction formula (QTcF) \\> 480 msecs based on Fredericia's formula (unless pacemaker in place)\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    * Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.\n    * Patients on strong CYP3A4 inducers must discontinue the drug 14 days prior to registration.","60 Years",{"count":360,"type":21},421,[92],"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.",[30],{"date":225,"type":49},{"date":366,"type":49},"2023-10-20",{"date":368,"type":21},"2038-08-31",{"name":370,"class":207},"Alliance for Clinical Trials in Oncology",238,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"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":382,"type":21},55,[25],"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.",[125],[132,387,98,388],"Previously untreated mantle-cell lymphoma","R-CHOP","2026-07-31",{"date":391,"type":49},"2026-08-03",{"date":393,"type":49},"2025-09-05",{"date":395,"type":21},"2029-06-30",{"name":147,"class":56},22,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","PCI-32765CAN3001: 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":407,"type":21},700,[92],"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.",[71,72,30,34,411,192,412],"Diffuse Large B-cell Lymphoma","Chronic Graft Versus Host Disease",[414,415,416,417,418,419,420,421,422,423],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-07-30",{"date":389,"type":49},{"date":427,"type":49},"2013-09-09",{"date":429,"type":21},"2029-12-31",{"name":431,"class":56},"Janssen Research & Development, LLC",175,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":208},"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":441,"type":21},27,[25],"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.",[445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,30,462,463,248,464,465,466,467,468,469,470,471],"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","Hodgkin Lymphoma","Lung Carcinoma","Malignant Solid Neoplasm","Melanoma","Merkel Cell Carcinoma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma","Urothelial Carcinoma","2026-07-28",{"date":424,"type":49},{"date":475,"type":49},"2025-12-18",{"date":477,"type":21},"2026-12-18",{"name":479,"class":207},"Mayo Clinic",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"100467353","phase-1-iks03-in-patients-with-advanced-b-cell-non-hodgkin-lymphomas-100467353","NCT05365659","IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas","A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)","Inclusion Criteria:\n\n1. Males or females, ≥ 18 years of age\n2. Part I: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible\n3. Part II: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:\n\n   1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)\n   2. Follicular lymphoma (including duodenal-type follicular lymphoma)\n   3. Mantle cell lymphoma\n   4. B cell lymphomas not specified\n4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response\n5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy\n6. Must be in need of systemic treatment and not require immediate cytoreductive therapy\n7. Part I: measurable or non-measurable disease\n8. Part II: measurable disease according to The Revised Criteria\u002FLugano Classification\n9. Part I: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy\n10. ECOG performance status 0 or 1\n11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.\n12. Ability to understand and give written informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding\n2. Patients documented to be CD19-negative\n3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement\n4. Part 2: History of another malignancy within 2 years, with the exception of:\n\n   1. Treated, non-melanoma skin cancers\n   2. Treated carcinoma in situ (e.g., breast, cervix)\n   3. Controlled, superficial carcinoma of the urinary bladder\n   4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits\n   5. Papillary thyroid carcinoma Stage I treated surgically for cure\n5. Any of the following hematologic abnormalities at baseline (transfusion allowed \\> 5 days previous):\n\n   1. Hemoglobin \\\u003C 8.0 g\u002FdL\n   2. Absolute neutrophil count \\\u003C 1,000 per mm3\n   3. Platelet count \\\u003C 75,000 per mm3\n6. Any of the following laboratory abnormalities at baseline:\n\n   1. Total bilirubin \\> 1.5 × upper limit of normal (ULN); \\> 3 × ULN if with Gilbert's Syndrome\n   2. AST or ALT \\> 3 × ULN; \\> 5 × ULN if due to hepatic involvement by tumor\n   3. Estimated GFR ≤ 60 mL\u002Fmin corrected for BSA\n   4. Albuminuria defined as urine albumin to creatinine ratio \\\u003C 30 mg\u002Fg or \\\u003C 3 mg\u002Fmmol) by spot urine albumin\n7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:\n\n   1. PT or INR \\> 1.5 × ULN; \\> 3× ULN if anticoagulated)\n   2. PTT \\> 1.5 × ULN; \\> 3× ULN if anticoagulated\n8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:\n\n   1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin, corrected for BSA.\n   2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 45 mg\u002Fg or ≥ 4.5 mg\u002Fmmol by spot urine albumin\n9. Patients with:\n\n   1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable\n   2. Active uncontrolled bleeding or a known bleeding diathesis\n10. Significant cardiovascular disease or condition, including:\n\n    1. Congestive heart failure or angina pectoris requiring therapy\n    2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia\n    3. Severe conduction disturbance (e.g., 3rd degree heart block)\n    4. QTc interval ≥ 480 milliseconds\n    5. Left ventricular ejection fraction below the lower limit of normal or \\\u003C 50% by MUGA scan or echocardiogram\n    6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification\n    7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months\n11. Significant liver disease, including:\n\n    1. Non-infectious hepatitis\n    2. Hepatic cirrhosis (Child-Pugh Class B and Class C)\n12. Significant pulmonary disease or condition, including:\n\n    1. Significant symptomatic COPD, as assessed by the Investigator\n    2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis\n    3. History of pulmonary inflammatory disease, pneumonitis, ARDS\n    4. History of pneumonia within 1 month\n13. Significant corneal disease or condition, including history of or current evidence of keratitis\n14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months\n15. Known HIV infection or AIDS\n16. Active hepatitis B virus or hepatitis C virus infection\n17. Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks\n18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications\n19. Unresolved Grade \\> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and\u002For endocrine end-organ failure being adequately managed by HRT)\n20. Known or suspected hypersensitivity to any of the excipients of formulated study drug\n21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks\n22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)\n23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process\n\nDrugs and Other Treatments to be Excluded:\n\n1. Receipt of:\n\n   1. Any CD19-targeted therapy within 4 weeks\n   2. Any tumor vaccine within 6 weeks (must have progressed if previously received)\n2. Prior autologous\u002Fallogeneic CAR-T therapy if known to be CD19-negative after\n3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 3 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)\n4. Any other investigational treatments within 3 weeks\n5. Drugs known to impair renal function, including:\n\n   1. NSAIDS within 3 days\n   2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week\n   3. Bisphosphonates within 1 month\n6. Prior solid organ transplant\n7. Allogeneic HSCT within 6 months, or:\n\n   1. If receiving immunosuppression\n   2. If with active evidence of GVHD\n8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months\n9. Radiotherapy:\n\n   1. To target lesions within 4 weeks unless progression of the lesion has been documented\n   2. To non-target lesions within 1 week\n10. Live\u002Flive-attenuated vaccines against infectious diseases within 4 weeks\n11. Immunosuppressive or systemic glucocorticoid therapy (\\> 10 mg prednisone daily or equivalent) within 2 weeks\n12. Prophylactic use of hematopoietic growth factors within 1 week\n13. Herbal therapies and supplements within 2 weeks\n14. Strong inhibitors of cytochrome P450 within 2 weeks",{"count":488,"type":21},140,[24],"This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).",[127,73,34,30,492],"B-cell Lymphoma",[494,495,496,40,98,497,498,194],"CD19","non-Hodgkin lymphoma","NHL","advance lymphoma","IKS03","2026-07-27",{"date":501,"type":49},"2026-07-29",{"date":503,"type":49},"2023-09-05",{"date":505,"type":21},"2028-09",{"name":507,"class":56},"Iksuda Therapeutics Ltd.",13,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":176},"100535503","phase-2-glofitamab-with-pirtobrutinib-for-relapsed-or-refractory-mantle-cell-lymphoma-100535503","NCT06252675","Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of signing the informed consent form.\n* Have a life expectancy (in the opinion of the investigator) of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 2 (Karnofsky \\> 60%).\n* History of previously treated MCL meeting the following criteria: Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing chemotherapy.\n* At least one bi-dimensionally measurable nodal lesion ( \\> 1.5 cm in its largest dimension by PET\u002FCT scan), or at least one bi-dimensionally measurable extranodal lesion ( \\> 1.0 cm in its largest dimension by PET\u002FCT scan) and FDG-avid.\n* Availability of leftover tissue from the time of progression for pathology confirmation and correlative studies. Note: Formalin fixed paraffin embedded blocks are preferred. If blocks are not available, 12-15 slides containing unstained, serial sections are acceptable.\n* Hemoglobin ≥ 9 g\u002FdL (Independent of transfusions and within 7 days prior to screening assessment).\n* Absolute neutrophil count \\>= 1.0 x 10\\^9\u002FL (Independent of growth factor support and within 7 days prior to screening assessment).\n* Platelets ≥ 75 x 10\\^9\u002FL or \\>= 50 x 10\\^9\u002FL if due to bone marrow involvement (Independent of transfusions and within 7 days prior to screening assessment, and independent of growth factor support and within 7 days prior to screening assessment). If the patient is cytopenic there should be no evidence of myelodysplasia orhypoplastic bone marrow.\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (or ≤ 3 x ULN for participants with Gilbert syndrome, or \\\u003C= 3 x ULN if due to underlying lymphoma).\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) \\\u003C= 2.5 X institutional upper limit of normal.\n* Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) \\\u003C= 2.5 X institutional upper limit of normal.\n* Creatinine clearance \\>= 50 mL\u002Fmin (by Cockcroft-Gault formula).\n* Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) \\\u003C= 1.5 x ULN.\n* Prothrombin (PT) or (international normalized ratio (INR) \\\u003C= 1.5 x ULN.\n* In women of childbearing potential, negative serum pregnancy test within 7 days prior to study treatment and either abstinence or use of highly effective contraception methods from the time of screening for at least 18 months after pre-treatment with obinutuzumab, 2 months after the final dose of glofitamab, 1 month after last dose of pirtobrutinib, 3 months after the final dose of tocilizumab (if applicable), whichever is longer. Women of childbearing potential should not donate oocytes for 1 month after last dose of pirtobrutinib.\n* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, with female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 3 months after pre-treatment with obinutuzumab, 2 months after the final dose of glofitamab, 28 days after last dose of pirtobrutinib, 3 months after the final dose of tocilizumab (if applicable), whichever is longer.\n* 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.\n* Participants with prior treatment-related adverse events (AEs) must have recovered to grade \\\u003C= 1 with the exception of alopecia and grade 2 peripheral neuropathy.\n* Participants must be able to swallow oral medications.\n* Participants with positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HBsAg) require a negative hepatitis B polymerase chain reaction (PCR) evaluation before initiating study treatment on cycle 1 day 1. Participants with positive anti-HBc antibody are required to receive prophylactic antiviral therapy with lamivudine, tenofovir, or entecavir for the duration of treatment and for at least 6 months following the end of study treatment. Hepatitis B PCR should be repeated as clinically indicated.\n* Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Pregnant, or intention of becoming pregnant during the study or within 18 months after treatment with obinutuzumab or 2 months after the last dose of glofitamab, or 3 months after treatment with tocilizumab, whichever is longer; and 1 month after the last dose of pirtobrutinib.\n* Participants should avoid chest-feeding until at least 1 week after discontinuing pirtobrutinib.\n* Have received the following treatments\u002Fprocedures prior to study entry:\n\n  * 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)\n  * Participants who discontinued a covalent BTK inhibitor due to disease progression or relapse. NOTE: Participants who discontinued covalent BTK inhibitor therapy due to intolerance will not be excluded. Covalent BTK inhibitor intolerance is defined as:\n\n    * Any grade 3 or higher non-hematologic toxicity, except a major bleeding event or grade \\>= 3 arrhythmia which are exclusion criteria\n    * Any grade 1 or higher non-hematologic toxicity that lasted longer than 7 days or recurred\n    * Any grade 4 hematologic toxicity\n    * Neutropenic fever\n    * Discontinuation due to drug interaction\u002Fexpected toxicity with resolution of prior covalent BTK inhibitor-related toxicities\n  * Any CD20\u002FCD3-directed bispecific antibodies for treatment of lymphoma\n  * Allogeneic stem cell transplant (SCT) within 6 months or on active immunosuppression or active graft versus host disease (GVHD)\n  * Solid organ transplantation\n* Have received the following treatments\u002Fprocedures prior to study entry whether investigational or approved, within the respective time periods prior to initiation of study treatment:\n\n  * Radiotherapy within 2 weeks prior to the first dose of study treatment. Note: If participants have received radiotherapy within 4 weeks prior to the first study treatment administration, participants must have at least one measurable lesion outside of the radiation field\n  * Autologous SCT within 90 days prior to first study treatment\n  * Chimeric antigen receptor (CAR) T-cell therapy within 60 days before first study treatment or if ongoing toxicity ≥ grade 2\n  * Use of monoclonal antibodies or antibody-drug conjugates within 4 weeks prior to first study treatment\n  * Use of radioimmunoconjugates within 12 weeks prior to first study treatment\n  * Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment. Note: Systemic corticosteroid treatment . 10 mg\u002Fday prednisone or equivalent and inhaled corticosteroids are permitted. Administration of acute, low-dose, systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) is permitted. The use of mineralocorticoids for management of orthostatic hypotension and corticosteroids for management of adrenal insufficiency is permitted\n  * Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment\n* Evidence of active central nervous system (CNS) lymphoma or leptomeningeal infiltration\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Note: Participants with a history of stroke who have not experienced a stroke or transient ischemic attack within the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed\n* Active second malignancy unless the patient is in remission and has a life expectancy \\> 2 years.\n* Major surgical procedure (under general anesthesia) within 30 days of day 1 of protocol therapy. Note: If a patient had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins).\n* 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, Sjogren's syndrome, Guillain- Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis Note: Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone, participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia, and participants with a history of type I diabetes mellitus who are well controlled (defined as a screening glycosylated hemoglobin (hemoglobin A1c) ≤ 8% and no urinary ketoacidosis) may be eligible for this study. Investigators should consult the sponsor-investigator.\n* Significant or extensive history of cardiovascular disease such as New York Heart Association class III or IV or objective class C or D cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina or acute coronary syndrome within the past 2 months prior to start of study treatment (cycle 1 day 1 (C1D1)), uncontrolled or symptomatic arrhythmias, and\u002For documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to start of study treatment (C1D1)\n* Prolongation of the QTc for heart rate using Fridericia's Formula (QTcF) \\> 470 msec. Note: Correction of QTc for underlying bundle branch block is permissible.\n* Significant pulmonary disease that is expected to interfere with therapy.\n* History of confirmed progressive multifocal leukoencephalopathy (PML).\n* Known active infection (including Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)), or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B and hepatitis C), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks (relating to the completion of the course of antibiotics) prior to first study treatment administration.\n* Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* 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 participants with unknown HIV status, HIV testing will be performed at screening and result must be negative for enrollment.\n* Participants with a history of bleeding diathesis.\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n* A known hypersensitivity to any of the excipients of pirtobrutinib or to any of the intended study medications.\n* Participants requiring ongoing therapy with strong Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or inducers will be excluded. For participants who are able to discontinue therapy with a strong CYP3A modulator, a washout period of at least 5 half-lives is required before beginning study treatment.",{"count":517,"type":21},30,[25],"This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory mantle cell lymphoma.",[30],"2026-07-22",{"date":523,"type":49},"2026-07-24",{"date":525,"type":49},"2024-06-11",{"date":527,"type":21},"2028-07-31",{"name":529,"class":207},"University of California, San Francisco",{"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":45,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":176},"100505412","phase-1-glofitamab-with-obinutuzumab-venetoclax-and-lenalidomide-for-the-treatment-of-patients-with-newly-diagnosed-high-risk-mantle-cell-lymphoma-100505412","NCT05861050","Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma","Phase 1\u002F2 Study of the Combination of Glofitamab, Venetoclax and Lenalidomide in Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: \\>= 18 to 80 years\n* Eastern Cooperative Oncology Group =\\\u003C 2\n* Diagnosis of MCL established by histologic assessment including one of the following:\n\n  * Immunohistochemistry of the biopsy\n  * Flow cytometry of the biopsy\n* Evidence of t(11;14) translocation involving the cyclin D1 gene by fluorescence in situ hybridization (FISH), and\u002For cyclin D1 expression by immunohistochemistry (IHC) unless disease is morphologically consistent with MCL and has IHC expression of SOX11\n* Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received\n\n  * Local radiotherapy not exceeding a total dose of 20 Gy at least 2 weeks prior the first dose of study therapy is allowed\n* Laboratory, radiographic, physical exam findings and\u002For symptoms attributable to MCL\n\n  * Asymptomatic patients with blastoid or pleomorphic variant can be enrolled\n* High risk features as classified by Jain et al.\n\n  * Blastoid\u002Fpleomorphic variants\n  * Ki67 \\>= 50%\n  * Presence of a TP53 mutation defined by either molecular testing or IHC\n  * del (17p) by FISH\n  * Complex karyotype\n  * High-risk Mantle Cell Lymphoma International Prognostic Index (MIPI) score (\\>= 6.2)\n  * Bulky disease\n  * The presence of other high risk gene mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1) as long one of the other features above are present\n* Ability to swallow oral capsules\u002Ftablets\n* Without bone marrow involvement: absolute neutrophil count (ANC) \\>= 1,000\u002Fmm\\^3 With bone marrow involvement: ANC \\>= 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets \\>= 75,000\u002Fmm\\^3 With bone marrow involvement: Platelets \\>= 25,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Hemoglobin \\>= 8 g\u002FdL With bone marrow involvement: Hemoglobin \\>= 7 g\u002FdL\n\n  * NOTE: Red Blood cells transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN\n* Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN\n* Creatinine clearance of \\>= 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =\\\u003C 1.5 x ULN If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Women of childbearing potential (WOCBP): negative serum pregnancy test\n* Agreement by females and males of childbearing potential to use an effective method of birth control (i.e., failure rate of \\\u003C 1% per year) or abstain from heterosexual activity for the course of the study treatment period through at least 30 days after the last dose of venetoclax and lenalidomide, 18 months after the last dose of obinutuzumab, 2 months after the last dose of glofitamab, or 4 months after the last dose of tocilizumab (if applicable) whichever is longer\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\n    * All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) (registered trademark) program and be willing and able to comply with the requirements of the REMS (registered trademark) program (including use of aspirin \\[ASA\\]\u002F Food and Drug Administration \\[FDA\\] approved blood thinner)\n    * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS (registered trademark) program\n\nExclusion Criteria:\n\n* Treatment with the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)\n* Treatment with strong or moderate CYP3A inhibitors or strong CYP3A inducers within 4 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug. Consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to first dose of venetoclax\n* Ongoing corticosteroid use \\> 30 mg\u002Fday of prednisone or equivalent. Patients who received corticosteroid treatment with =\\\u003C 30 mg\u002Fday of prednisone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration prior to day 1 of cycle 1. Patients may have received a brief (=\\\u003C 7 days) course of systemic steroids (\\>= 100 mg prednisone equivalent per day) prior to initiation of study therapy for control of lymphoma-related symptoms\n\n  * Corticosteroid therapy for control of cancer symptoms is permitted\n  * The use of inhaled corticosteroids is permitted\n  * The use of mineralocorticoids for management of orthostatic hypotension is permitted\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted\n* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Prior solid organ transplantation within 60 months and requiring active immunosuppression\n* Receipt of live-virus vaccine within 28 days prior to the initiation of the study treatment or need for live-virus vaccines at any time during the study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n  * Patients with any other malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \\>= 2 years prior to enrollment are eligible\n  * Patients receiving adjuvant endocrine therapy for non-metastatic, hormone receptor positive breast cancer for \\>= 2 years prior to enrollment are eligible\n* Major surgery (within 4 weeks prior to the start of the first dose of study treatment), other than for diagnosis\n* Known or suspected chronic active Epstein-Barr viral infection\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Known allergy to both xanthine oxidase inhibitors and rasburicase\n* Positive for hepatitis C virus (HCV) virus by polymerase chain reaction (PCR) at screening. Testing only required if the hepatitis (Hep) C antibody is positive\n* Positive test results for hepatitis B virus (HBV) infection (defined as positive surface antigen \\[HBsAg\\]) at screening\n\n  * Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \\[HBcAb\\]) may be included if HBV deoxyribonucleic acid (DNA) is undetectable, if they are willing to undergo DNA testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy\n* Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \\> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures\n* Significant or extensive cardiovascular disease such has New York Heart Association class III or IV cardiac disease or Objective Assessment class C or D, myocardial infarction within the last 6 months, unstable arrythmias or unstable angina\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment\n* Suspected or latent tuberculosis (confirmed by positive interferon -gamma release assay)\n* Females only: Pregnant or breastfeeding or intending to become pregnant during the study or within 18 months after the final dose of all study drugs\n\n  * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study drug\n* History of uncontrolled autoimmune condition or disease requiring active systemic treatment to manage except when on a stable regimen for the treatment of hypothyroidism, Type 1 diabetes mellitus or psoriasis\u002Feczema (topicals only)\n\n  * Patients with history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barre syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months\n  * Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment\n  * Patients with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease with active symptoms within last 60 months and on active immunosuppressive therapy, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, multiple sclerosis, or glomerulonephritis will be excluded\n* Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n\n  * Patients with a history of stroke who have not experienced a stroke or transient ischemic attack within the past 9 months and have no residual neurologic deficits, as judged by the investigator, are allowed\n* Clinically significant history of cirrhotic liver disease\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","80 Years",{"count":539,"type":21},50,[24,25],"This phase I\u002FII trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Lenalidomide works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving venetoclax, glofitamab with obinutuzumab, and lenalidomide together may kill more cancer cells in patients with newly diagnosed, high risk mantle cell lymphoma.",[543,30,544],"Blastoid Variant Mantle Cell Lymphoma","Pleomorphic Variant Mantle Cell Lymphoma","2026-07-20",{"date":521,"type":49},{"date":548,"type":49},"2023-08-10",{"date":550,"type":21},"2027-02-01",{"name":552,"class":207},"City of Hope Medical Center",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":270,"phases":4,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":176},"100647644","atrial-fibrillation-among-patients-with-hematologic-malignancies-on-tyrosine-kinase-inhibitor-therapy-100647644","NCT07711327","Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Age greater than 18 years\n* Diagnosis of chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL)\n* New initiation of Bruton's tyrosine kinase inhibitor (BTKI) therapy or non-BTKI therapy (eg, venetoclax based) for management of hematologic malignancy\n\nExclusion Criteria:\n\n* Prior exposure to BTKI therapy\n* History of persistent atrial fibrillation",{"count":560,"type":21},500,"This study looks at how often atrial fibrillation (AF), an irregular heart rhythm, occurs in people with certain blood cancers who are starting a type of cancer medicine called a Bruton's tyrosine kinase inhibitor (BTKI). Researchers will follow 400 people starting BTKI therapy and compare them to 100 people with similar blood cancers who are not taking a BTKI. Participants will wear a smartwatch and, later, a heart monitor patch to check for AF and other irregular heart rhythms over 12 months. The study will also look at whether AF affects cancer treatment, such as needing to pause, lower the dose, or stop the BTKI, and whether it leads to other health problems such as bleeding, stroke, or heart-related hospital visits.",[563,71,192,30,33],"Atrial Fibrillation (AF)",[565,566,420,132,567,568,569,570,571,572],"Bruton's Tyrosine Kinase Inhibitor","BTKI","Zanubrutinib","Cardio-oncology","ECG patch monitor","Smartwatch monitoring","Arrhythmia","Hematologic malignancy","NOT_YET_RECRUITING","2026-07-14",{"date":576,"type":49},"2026-07-17",{"date":578,"type":21},"2026-08",{"date":580,"type":21},"2031-08",{"name":582,"class":207},"Tina Baykaner",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":4},"100645909","phase-1-hdm2005-combination-therapy-in-relapsedrefractory-mantle-cell-lymphoma-100645909","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":157,"type":21},[24],"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.",[30],[595,416],"ROR1-ADC","2026-07-09",{"date":598,"type":49},"2026-07-13",{"date":600,"type":21},"2026-07-10",{"date":602,"type":21},"2028-12-01",{"name":604,"class":56},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"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":619,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":631},"100610273","phase-1-rituximab-rtx--tafasitamab-in-combination-with-allogeneic-nk-cells-for-treatment-of-relapsedrefractory-rr-b-cell-non-hodgkin-lymphoma-nhl-100610273","NCT07225439","Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma (NHL)","Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)\n* Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET\u002FCT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹\u002FL), lymphadenopathy ≥1.5 cm, and\u002For disease-related cytopenias (anemia, thrombocytopenia).\n* Relapsed and\u002For refractory after two or more lines of systemic therapy, including prior CD19 and\u002For CD20 directed therapies\n* For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and\u002For CD20 expression (by flow cytometry and\u002For immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy\n* ECOG Performance Status \\\u003C\u002F= 2\n* Preserved organ function as defined by: Total bilirubin \\\u003C\u002F= 1.5X upper limit of normal; AST\u002FALT \\\u003C\u002F= 2.5 X upper limit of normal; Calculated creatinine clearance \\>\u002F= 30mL\u002Fmin estimated by Cockcroft Gualt formula; cardiac ejection fraction \\>\u002F= 45% and no more than mild\u002Ftrace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \\>\u002F= 92% on room air.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator\n* Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment\n* New York Heart Association class III-IV congestive heart failure\n* Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration\n* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \\\u003C200 copies\u002FmL on antiretroviral therapy\n* Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Morphologic and\u002For cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy\n* 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)\n* Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration\n* History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months",{"count":613,"type":21},15,[24],"This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.\n\nNK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).\n\nParticipants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.",[310,617,73,308,618,34,71,72,33,30],"B-cell Non Hodgkin Lymphoma","Primary Mediastinal Large B Cell Lymphoma",[620,621],"NK cells","Natural Killer cells","2026-07-06",{"date":624,"type":49},"2026-07-08",{"date":626,"type":21},"2026-09",{"date":628,"type":21},"2027-12",{"name":630,"class":207},"Paolo Caimi, MD",2,{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":270,"phases":4,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":631},"100324252","evaluation-of-human-immune-responses-vaccination-in-patients-with-lymphoma-100324252","NCT03501576","Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma","Inclusion Criteria:\n\n* Subjects with a diagnosis of lymphoma falling into the following categories:\n\n  * B-NHL who have received 1 cycle of chemotherapy\n  * B-NHL in complete remission and within 12 months after completion of chemotherapy\n  * Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month\n  * B-NHL in complete remission for over 12 months\n  * Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy\n* Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.\n\n  * Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:\n\nHematology:\n\n* Hemoglobin: 7.0-16.1 gm\u002FdL\n* Platelet count: 10-600\u002FµL\n* Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season \\*- Platelet count: 10-600\u002FuL\n\n  * For cohort 1: Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.\n  * For cohort 3: Subjects must have previously received at least 1 dose of SARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine will be eligible to enroll in cohort.\n\nExclusion Criteria:\n\n* Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient\n* Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study\n* Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection\n* Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months\n* Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine\n* Have a history of Guillain-Barre syndrome (GBS)\n* Subjects who had or are suspected to have had an influenza infection in the current influenza season\n* Subjects who, at screening, have abnormal vital signs and\u002For physical exam, including a temperature ≥ 38.0 C, systolic blood pressure ≤ 90 or \\> 180 mmHg, pulse ≤ 60 or \\> 130 beats per minute, new rash, signs of infection\n* Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season\n* Subjects enrolled in hospice or whose life expectancy is less than 6 months",{"count":639,"type":21},200,"This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.",[71,642,34,30,643],"Diffuse Large B-Cell Lymphoma","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","2026-07-01",{"date":622,"type":49},{"date":647,"type":49},"2018-04-06",{"date":649,"type":21},"2028-05-26",{"name":651,"class":207},"Emory University",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":22,"phases":661,"briefSummary":662,"conditions":663,"keywords":664,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":677},"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":660,"type":21},41,[25],"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.",[30],[30,98,665,666,667],"CAR T cell","Inadequate response","Relapse","2026-06-24",{"date":670,"type":49},"2026-06-25",{"date":672,"type":49},"2026-06-05",{"date":674,"type":21},"2030-06-15",{"name":676,"class":207},"Fondazione Italiana Linfomi - ETS",14,{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":683,"acronym":4,"eligibilityCriteria":684,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":358,"enrollmentInfo":685,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":709,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":720,"locationsCount":208},"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":90,"type":21},[25],"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).",[689,690,247,315,691,692,693,694,695,696,697,71,72,698,34,190,699,700,701,702,191,703,248,704,705,706,707,708],"Acute Leukemia","Acute Myeloid Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelofibrosis","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[710,17,711,496,221,712,713],"AML","MDS","CML","SLL","2026-06-23",{"date":670,"type":49},{"date":717,"type":49},"2018-03-30",{"date":719,"type":21},"2028-06-10",{"name":721,"class":207},"Masonic Cancer Center, University of Minnesota",{"id":723,"slug":724,"hasResults":12,"nctId":725,"briefTitle":726,"officialTitle":726,"acronym":727,"eligibilityCriteria":728,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":729,"targetDuration":4,"studyType":22,"phases":730,"briefSummary":732,"conditions":733,"keywords":737,"overallStatus":573,"whyStopped":4,"lastUpdateSubmitDate":744,"lastUpdatePostDateStruct":745,"startDateStruct":747,"completionDateStruct":748,"leadSponsor":750,"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":157,"type":21},[731],"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.",[273,734,735,190,736,30],"Follicular Lymphoma ( FL)","Waldenstrom Macroglobulinaemia","Marginal Zone B Cell Lymphoma",[165,738,739,740,741,742,743,568],"Hypertension","Telemonitoring","Connected device","Blood pressure","Lymphoid malignancies","Advanced practice nursing","2026-06-18",{"date":746,"type":49},"2026-06-22",{"date":644,"type":21},{"date":749,"type":21},"2027-12-31",{"name":751,"class":207},"Centre Hospitalier de la côte Basque"]