[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"marginal-zone-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:marginal-zone-lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,51,83,110,137,163,188,215,248,276,317,347,372,393,417,441,460,490,514,538,563,586,612,634,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100582251","combating-cancer-related-fatigue-a-personalized-supportive-care-program-100582251",false,"NCT06860880","Combating Cancer-Related Fatigue: A Personalized Supportive Care Program","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Confirmed diagnosis of indolent lymphoma, Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma.\n* Significant symptoms of fatigue, as defined by PROMIS Fatigue score \\>50.\n\nExclusion Criteria:\n\n* Other co-existing malignancies.\n* Significant cognitive impairment as defined by Mini-Cog score 0-2 (out of 5) that would prevent understanding of assessments or interventions.\n* Unstable or serious illness (e.g., unstable cardiac arrhythmia, severe anemia\u002Fthrombocytopenia) that would prevent safe participation in an exercise regimen, per the discretion of the treating physician.\n* Individuals who are not able to consume an oral diet, due to swallowing difficulties or other reasons, as this might interfere with the nutritional intervention","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","This health services study will assess a multidisciplinary intervention program directed at fatigue mitigation among patients diagnosed with indolent lymphomas. Specifically, 30 subjects with chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL) and 10 subjects with Follicular Lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), Waldenström's Macroglobulinemia, or Cutaneous T Cell Lymphoma (CTCL) will be included.",[26,27,28,29,30,31,32,33,34],"Indolent Lymphomas","Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Lymphoplasmacytic Lymphoma","Waldenstrom Macroglobulinemia","Cutaneous T Cell Lymphoma",[36,37],"exercise","dietary intervention","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-07-01","ACTUAL",{"date":44,"type":42},"2025-06-03",{"date":46,"type":20},"2026-12-31",{"name":48,"class":49},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100447009","phase-3-a-study-of-zanubrutinib-plus-anti-cd20-versus-lenalidomide-plus-rituximab-in-participants-with-relapsedrefractory-follicular-or-marginal-zone-lymphoma-100447009","NCT05100862","A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed\u002FRefractory Follicular or Marginal Zone Lymphoma","A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed\u002FRefractory Follicular or Marginal Zone Lymphoma","MAHOGANY","Key Inclusion Criteria:\n\n* Histologically confirmed grade 1-3a FL or MZL\n* Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy\n* Need for systemic therapy for FL or MZL\n* Measurable disease by computed tomography or magnetic resonance imaging\n* Adequate bone marrow, liver and renal function\n\nKey Exclusion Criteria:\n\n* Transformation to aggressive lymphoma\n* Requiring ongoing need for corticosteroid treatment\n* Clinically significant cardiovascular disease\n* Prior malignancy within the past 2 years\n* Active fungal, bacterial, and\u002For viral infection that requires systemic therapy\n* Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\\\u003C 24 months)\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":60,"type":20},780,[62],"PHASE3","The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\\^2) in participants with relapsed\u002Frefractory (R\u002FR) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET\u002FCT), and to compare the efficacy of zanubrutinib plus rituximab versus R\\^2 in participants with R\u002FR marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.",[65,31],"Relapsed\u002FRefractory Follicular Lymphoma",[67,68,69,70,71],"Zanubrutinib","BGB-3111","Rituximab","Lenalidomide","Obinutuzumab","2026-06-17",{"date":74,"type":42},"2026-06-18",{"date":76,"type":42},"2022-03-10",{"date":78,"type":20},"2030-06",{"name":80,"class":81},"BeOne Medicines","INDUSTRY",277,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":92,"type":20},645,[94,95],"PHASE1","PHASE2","Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[98,31,30,99,100,28,29,101,102],"B-cell Malignancy","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma",{"date":74,"type":42},{"date":105,"type":42},"2021-09-13",{"date":107,"type":20},"2029-11",{"name":80,"class":81},127,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":50},"100564976","early-phase-1-64cu-llp2a-for-imaging-hematologic-malignancies-100564976","NCT06636175","64Cu-LLP2A for Imaging Hematologic Malignancies","Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B","Inclusion Criteria Healthy Volunteer:\n\n* Adult 18 years of age or older\n* Able to give informed consent.\n* Able to comprehend and willing to follow instructions for study procedures as called for by the protocol\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.\n\nInclusion Criteria Hematological Malignancy:\n\n* Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:\n\n  * Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria\n  * Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma\u002Fchronic lymphocytic leukemia\n* Adult 18 years of age or older and able to provide informed consent\n* Capable of lying still and supine within the PET\u002FCT scanner for up to 75 minutes.\n* No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative\n* Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate",true,{"count":119,"type":20},42,[121],"EARLY_PHASE1","This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.",[124,125,30,31,32,29,28],"Multiple Myeloma","Low-Grade Lymphoma",[127,128],"PET","Imaging","2026-06-15",{"date":72,"type":42},{"date":132,"type":42},"2025-03-20",{"date":134,"type":20},"2027-03-31",{"name":136,"class":49},"Washington University School of Medicine",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100516561","phase-3-mosunetuzumab-lenalidomide-versus-investigator-choices-in-patients-with-relapsed-or-refractory-marginal-zone-lymphoma-100516561","NCT06006117","Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma","Phase III, Multicenter, Open Label, Randomized, Controlled Study Investigating Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma","Inclusion criteria:\n\n1. Have a biopsy proven diagnosis of MZL, extranodal (EMZL) or nodal (NMZL) Or have a diagnosis of splenic MZL (SMZL) based on mandatory 13 flow cytometry markers: surface immunoglobulins (SmIg), CD5, CD23, FMC7, CD22 or CD79b, CD200, CD180, CD20, CD43, CD11c, CD10,CD103 and CD123 and validated by a centralized review.\n\n   In case of large dissemination, disseminated MZL (as evaluated by investigator; please contact the Sponsor to discuss any doubt) will be included as DMZL and included in NMZL subtype. Participants with high tumor burden criteria are eligible.\n\n   Participants with borderline or related entities, such as splenic diffuse red pulp lymphoma (SDRPL), typical hairy cell leukemia (HCL), and HCL variant (HCLv), are not eligible.\n2. Have been treated with at least one prior systemic treatment and not more than three prior lines. Previous line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles; participants treated with monoclonal antibody monotherapy should have received at least 4 weekly injections) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as BTK inhibitors (at least 1 month). Participants previously treated by lenalidomide are eligible if the last administration of lenalidomide is superior to 12 months before C1D1. When randomized in comparator arm, those participants should require R-chemo. Prior local therapy (including surgery, radiotherapy antibiotics for H. pylori-positive gastric lymphoma, and antiviral for hepatitis C virus) is not considered as one line of treatment\n3. Signed Informed Consent Form\n4. Age ≥ 18 years at the time of signing the informed consent form\n5. Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement\n6. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2\n7. Have a symptomatic disease requiring a systemic treatment\n8. Not eligible for a local treatment including radiotherapy or surgery\n9. Stage I disease of EMZL, SMZL or NMZL may be eligible only if not candidate to local therapy (surgery or radiotherapy).\n10. Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with ≥ 15 mm in longest transverse diameter or the short diameter must measure ≥ 10 mm regardless of the longest transverse diameter.\n\n    Spleen is considered as a measurable disease if vertical axis is higher than 130 mm.\n11. Adequate hematopoietic function at screening as follows unless cytopenia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune thrombocytopenia:\n\n    11.1. Platelet count ≥ 75 G\u002FL; in cases of thrombocytopenia clearly due to marrow involvement of MZL or hypersplenism or auto-immune thrombocytopenia, platelet count should be ≥ 30 G\u002FL. Washout platelet transfusion is 7 days between transfusion and D1 of starting treatment 11.2. Absolute Neutrophil Count (ANC) ≥ 1 G\u002FL unless neutropenia is clearly due to marrow involvement of MZL or hypersplenism. G-CSF is not allowed within 7 days before starting treatment 11.3. Total hemoglobin ≥ 8 g\u002FdL unless anemia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune hemolytic anemia. Washout erythrocyte transfusion is 7 days between transfusion and D1 of starting treatment\n12. Serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN) (or ≤3 x ULN for participants with Gilbert syndrome),\n13. AST or ALT ≤ 2.5 x ULN, unless directly attributable to the participant's MZL\n14. Measured or estimated creatinine clearance ≥ 40 mL\u002Fmin by institutional standard method\n15. Participants who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation. Participants who are hepatitis B surface antigen (HBsAg) negative, hepatitis B surface antibody (anti-HBsAb) positive and hepatitis B core antibody (HBcAb) negative are eligible,\n16. Contraception:\n\n    16.1. For women of childbearing potential (WOCBP) (refer to section 14.6.1):\n    * must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.\n    * must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustine (if applicable) and 12 months after the final dose of rituximab (if applicable).\n\n    16.2. For men: with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable). ). Men must also agree to refrain from donating sperm from the first day of treatment until at least 7 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), and 12 months after the final dose of rituximab (if applicable)\n17. Participants covered by any social security system (France).\n18. Participants who understand and speak one of the country official languages.\n19. LVEF within normal range (i.e. \\> 50% as evaluated by Transthoracic Echocardiography or \\> 45% as evaluated by isotopic method (MUGA scan)).\n\nExclusion criteria:\n\n1. MZL with histologic transformation to high-grade lymphoma\n2. Participants who have received any of the following treatments prior to study entry:\n\n   * Treatment with mosunetuzumab or other CD20\u002FCD3-directed bispecific antibodies\n   * Allogeneic stem cell transplant\n3. Participants who have received any of the following treatments, 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\n   * Autologous stem cell transplant within 100 days prior to first study treatment\n   * Use of monoclonal antibodies within 4 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) and corticosteroids on the long run with the following exceptions: inhaled steroids for asthma, topical steroids, or replacement or stress corticosteroids during the study at any time. Participants who require lymphoma symptom control during screening may receive corticosteroid \\\u003C or = 1mg\u002Fkg\u002Fday prednisone or equivalent for a maximum of 10 days prior to first dose of study treatment.\n   * Any other anti-cancer investigational therapy within 4 weeks prior to initiation of study treatment.\n4. Pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of lenalidomide, 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP, 6 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable).\n5. Received a 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 6 months after the final dose of study treatment, except for acute pandemic situation such as COVID19\n6. Active or history of CNS lymphoma or leptomeningeal infiltration\n7. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) - grade 3 and 4\n8. Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including Mannitol\n9. Participants unable to receive adequate prophylaxis and\u002For therapy for thromboembolic events (aspirin or low molecular weight heparin or direct oral anticoagulants)\n10. History of prior malignancy, except for conditions as listed below if participants have recovered from the acute side effects incurred as a result of previous therapy and only with a single occurrence of the following conditions:\n\n    * Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated cervical carcinoma in situ without evidence of disease\n    * Surgically\u002Fadequately treated low grade, early stage I, localized prostate in situ carcinoma\n11. Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to inclusion or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds),\n12. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:\n\n    * Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)\n    * Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n    * Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis\n    * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.\n13. History of confirmed progressive multifocal leukoencephalopathy (PML)\n14. Known Positive serologic HIV test at screening\n15. Acute or chronic hepatitis C virus (HCV) infection Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.\n16. Known or suspected history of hemophagocytic lymphohistiocytosis\n17. Known or suspected chronic active Epstein-Barr virus (EBV) infection within the last 4 weeks prior to inclusion\n18. History of erythema multiforme, Grade ≥3 rash, or blistering following prior treatment with immunomodulatory derivatives\n19. History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis\n20. Active autoimmune disease requiring treatment\n21. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; except:\n\n    * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n    * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible\n    * Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Medical Monitor.\n22. Recent major surgery with risk of bleeding within 4 weeks prior to first study treatment administration (C1D1)\n23. History of solid organ transplantation\n24. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study\n25. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n26. Person hospitalized without consent\n27. Adult person under legal protection\n28. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness\n29. Participant unable to receive at least one of the three regimens of the comparator arm. As in usual practice, physician has to verify the absence of contraindication to the use of the drugs, hypersensitivity, and to take into account the lymphoma history and previous treatment scheme used\n30. Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment (e.g. very high SUV (SUV \\> 20 or double compared to SUV of other lesions) in at least one lesion that was not biopsied, and discordant with SUV of biopsied lesion, LDH \\> 2.5 ULN in a context of rapidly progressive disease, etc). Please contact the Coordinating Investigators \u002F Sponsor to discuss such cases or if there is any doubt before considering enrollment.\n31. Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment within 48 hours (participants with controlled disease after adequate pleural\u002Fserous drainage and\u002For effective pleurX™ or similar system are eligible only if control system is in place before randomization).\n32. Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if control system is in place before randomization).",{"count":145,"type":20},260,[62],"This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R\u002FR MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib.\n\nThe patients will be Randomized as follows:\n\nArm A - Experimental arm:\n\n• Mosunetuzumab-Lenalidomide\n\nArm B - Comparator arms ( Investigator Choices):\n\n* Rituximab-Lenalidomide\n* Rituximab-Bendamustine\n* Rituximab-CHOP",[31],[150,151,31,152,153],"Bispecific antibodies, Subcutaneous","Step-up dosing","Investigator choices","R\u002FR MZL","2026-06-12",{"date":129,"type":42},{"date":157,"type":42},"2023-09-05",{"date":159,"type":20},"2032-09",{"name":161,"class":49},"The Lymphoma Academic Research Organisation",48,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":170,"targetDuration":172,"studyType":173,"phases":4,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":50},"100638914","pomalidomide-plus-anti-cd20-antibody-and-prednisone-in-frontline-indolent-b-cell-lymphoma-100638914","NCT07609446","Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma","Pomalidomide Plus Anti-CD20 Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma: A Prospective, Multicenter, Phase II Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of sex;\n2. Confirmed diagnosis of follicular lymphoma (FL), or histopathologically confirmed CD20-positive marginal zone lymphoma (MZL), including extranodal marginal zone lymphoma (MALT), splenic marginal zone lymphoma (SMZL), and nodal marginal zone lymphoma (NMZL),or confirmed diagnosis of indolent mantle cell lymphoma (MCL);\n3. Patients with a confirmed diagnosis of chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL);\n4. Confirmed diagnosis of lymphoplasmacytic lymphoma\u002FWaldenstrom macroglobulinemia;\n5. Presence of indications for treatment of indolent B-cell lymphoma;\n6. No prior systemic antitumor therapy for lymphoma;\n7. ECOG-PS score 0-2;\n8. Essentially normal bone marrow hematopoietic function, with routine blood tests as follows: white blood cell count \\>3000\u002FuL, absolute neutrophil count ≥1.5 × 10\\^9\u002FL (use of granulocyte colony-stimulating factor is allowed), platelet count ≥75 × 10\\^9\u002FL (transfusion to reach this minimum platelet count is allowed), and hemoglobin ≥9.0 g\u002FdL (prior red blood cell transfusion or use of recombinant human erythropoietin is allowed). If peripheral blood abnormalities are caused by lymphoma involvement of the bone marrow or spleen, neutrophils≥1.0 × 10\\^9\u002FL and platelets≥50 × 10\\^9\u002FL are acceptable (the investigator may determine at his\u002Fher discretion whether enrollment is appropriate);\n9. Normal function of major organs:\n\n   1. Hepatic function: serum bilirubin ≤2.0 × ULN; serum ALT and AST ≤2.5 × ULN;\n   2. Renal function: creatinine clearance \\>30 mL\u002Fmin;\n10. Expected survival≥3 months as judged by the investigator; Voluntary written informed consent signed before trial screening;\n\nExclusion Criteria:\n\n1. Current or prior other malignancy, unless curative treatment has been performed and there has been no evidence of recurrence or metastasis within the past 5 years;\n2. Lymphoma involvement of the central nervous system or transformation to a higher-grade lymphoma;\n3. Hepatic or renal dysfunction unrelated to lymphoma: alanine aminotransferase (ALT) \\>3 times the upper limit of normal, aspartate aminotransferase (AST) \\>3 times the upper limit of normal, total bilirubin (TBIL) \\>2 times the upper limit of normal, or serum creatinine \\>1.5 times the upper limit of normal;\n4. Other serious medical conditions that would affect this study (e.g., uncontrolled diabetes, gastric ulcer, or other serious cardiopulmonary diseases). The investigator has the authority to make this determination;\n5. Severe or uncontrolled infection;\n6. Clinically manifest central nervous system dysfunction;\n7. Major surgery within the past 30 days (excluding lymph node biopsy);\n8. Pregnant or lactating women, or women of childbearing potential who have not used contraceptive measures;\n9. Allergy to the study drug; Patients considered unsuitable for enrollment by the investigator.",{"count":171,"type":20},30,"12 Months","OBSERVATIONAL","A Phase II Study of Pomalidomide Combined with Anti-CD20 Monoclonal Antibody and Prednisone in Frontline Indolent B-Cell Lymphoma Objective: This prospective, single-arm, Phase II trial aims to evaluate the efficacy and safety of first-line pomalidomide plus anti-CD20 antibody and prednisone in patients with indolent B-cell lymphoma.\n\nStudy Population: Approximately 30 adult patients (age ≥18 years) will be enrolled. Eligible histologies include follicular lymphoma (FL), CD20-positive marginal zone lymphoma (MZL: extranodal MALT, splenic SMZL, nodal NMZL), indolent mantle cell lymphoma (MCL), chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL), and lymphoplasmacytic lymphoma\u002FWaldenström macroglobulinemia. Patients must be treatment-naïve, have an indication for systemic therapy, ECOG performance status 0-2, and adequate bone marrow reserve (ANC ≥1.5×10⁹\u002FL, platelets ≥75×10⁹\u002FL, hemoglobin ≥9.0 g\u002FdL; lower thresholds permitted if marrow\u002Fspleen involvement, per investigator discretion). Adequate organ function is required: bilirubin ≤2×ULN, ALT\u002FAST ≤2.5×ULN, and creatinine clearance \\>30 mL\u002Fmin. Life expectancy must be ≥3 months, and written informed consent is mandatory.\n\nExclusion Criteria: Patients are excluded if they have another malignancy within 5 years (unless curatively treated without recurrence), CNS lymphoma involvement, transformation to high-grade lymphoma, uncontrolled infection, severe comorbidities affecting study participation, significant non-lymphoma-related organ dysfunction (ALT\u002FAST \\>3×ULN, bilirubin \\>2×ULN, creatinine \\>1.5×ULN), active CNS dysfunction, major surgery within 30 days, pregnancy or lactation, lack of contraception in women of childbearing potential, known drug hypersensitivity, or any condition deemed unsuitable by the investigator.\n\nTreatment Regimen: Induction consists of six 28-day cycles. Anti-CD20 antibody is administered at 375 mg\u002Fm² weekly during Cycle 1 and on Day 1 of Cycles 2-6. Pomalidomide is given at 4 mg\u002Fday on Days 2-22 of Cycles 1-6. Prednisone is administered at 100 mg\u002Fday on Days 1-5 of Cycles 1-6. Maintenance therapy continues for 2 years with pomalidomide 4 mg\u002Fday on Days 1-14 and anti-CD20 antibody 375 mg\u002Fm² on Day 1 every 8 weeks.\n\nEndpoints: The primary endpoint is overall response rate (ORR). Secondary endpoints include complete response rate (CR), progression-free survival (PFS), overall survival (OS), and safety (hematologic and non-hematologic adverse events).\n\nStatistical Methods: Continuous variables will be summarized with descriptive statistics; categorical variables with frequencies and percentages. Time-to-event endpoints (PFS, OS, and duration of response) will be analyzed using the Kaplan-Meier method, reporting medians, quartiles, and 90% confidence intervals, along with event and censoring counts. ORR will be tested statistically and reported with a 90% confidence interval.\n\nTimeline: The study is expected to begin in January 2026, complete enrollment by December 2026, and conclude by December 2027. The total planned sample size is 30 patients.",[176,30,31,177],"Indolent Lymphoma","Indolent Mantle Cell Lymphoma","NOT_YET_RECRUITING","2026-05-21",{"date":181,"type":42},"2026-05-27",{"date":183,"type":20},"2026-05-01",{"date":185,"type":20},"2027-12-31",{"name":187,"class":49},"The First Affiliated Hospital of Soochow University",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":205,"overallStatus":178,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":50},"100637441","phase-2-non-covalent-btk-inhibitor-nemtabrutinib-in-combination-with-the-cd20-monoclonal-antibody-rituximab-for-the-treatment-of-marginal-zone-lymphoma-100637441","NCT07583810","Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma","A Phase II Study of the Non-Covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab in Patients With Marginal Zone 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* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Diagnosis of MZL including splenic marginal zone lymphoma (SMZL), extra nodal marginal zone lymphoma (ENMZL) and nodal marginal zone lymphoma (NMZL), established by histologic assessment\n* Requiring treatment for MZL. Patients receiving prior systemic therapy as well as treatment naïve patients are eligible\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* Radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy (as defined by Lugano Classification for non-Hodgkin lymphoma \\[NHL\\])\n\n  * Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed\n  * Subjects with skin extranodal marginal zone lymphoma (EMZL) who do not meet the radiographically measurable disease criteria described herein are eligible provided that skin lesion measures ≥ 1.5 cm in diameter and is documented by photo or there are multiple skin lesions measuring \\> 1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL\n  * Subjects with gastric extra nodal MZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assess by multiple random gastric biopsies\n  * Subjects with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible provided that conjunctival lesion measures ≥ 1 cm in diameter and is documented by photo or there are multiple conjunctival lesions measuring together \\> 1 5cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs be histologically confirmed as MZL\n* Willing to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy\n\n  * Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained before the date of the first dose of study treatment; bone marrow sample must show histologically confirmed infiltration of MZL\n* At least one of the following criteria for treatment initiation:\n\n  * Involvement of ≥ 3 nodal sites, each with diameter of ≥ 3 cm\n  * Any nodal or extra nodal tumor mass with a diameter of ≥ 5 cm\n  * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \\> 10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse\n  * Risk of local compressive symptoms that may result in organ compromise\n  * Splenomegaly or splenic lesion without splenomegaly\n  * Leukopenia attributed to MZL (leukocytes \\\u003C 1000\u002Fmm\\^3)\n  * Leukemia (\\> 5,000 lymphoma cells\u002Fmm\\^3)\n  * Threatened organ function, especially for extra nodal MZL\n  * Requirement for transfusion or growth factor support attributed to lymphoma\n  * Involvement of 2 or more extra nodal sites, with tumor\u002Flesion in each extra nodal site ≥ 1 cm\n  * Progression or relapsed within 24 months after MZL diagnosis in patients previously treated with ≥ 1 line of systemic therapy\n* Life expectancy \\> 3 months\n* Prior adverse events (AEs) must be resolved to grade 1\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement.\n* With bone marrow involvement: Platelets ≥ 30,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement.\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  * Subjects with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in the presence of liver involvement by lymphoma\n* Creatinine clearance of ≥ 45 mL\u002Fmin\u002F1.73 m\\^2 using the Modification of Diet in Renal Disease formula OR ≥ 45 mL\u002Fmin by the Cockcroft-Gault formula\n* Seronegative for hepatitis C virus (HCV), hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HBV or HCV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n\nPatients with occult or prior HBV infection (defined as negative hepatitis B virus surface antigen \\[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\n\n* Participants with HIV are eligible if they meet ALL the following:\n\n  * CD4 count \\> 350 cells\u002FµL at screening\n  * The HIV viral load is below the detectable level as per locally available testing\n  * Are on a stable antiretroviral therapy (ART) regimen for at least 4 weeks prior to study entry\n\n    * NOTE: ART includes drugs, which are NOT strong cytochrome P450 (CYP)3A4 inducers (participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study)\n  * HIV screening tests are not required unless:\n\n    * Known history of HIV infection\n    * As mandated by local health authority\n  * Are compliant with their ART\n\n    * NOTE: If the participant has had an AIDS defining opportunistic infection in the past 12 months prior to screening, they are not eligible to be included in the study\n* Person of childbearing potential (POCBP): Negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants assigned male sex at birth:\n\n  * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n    * Nemtabrutinib: 12 days\n    * Rituximab: 3 months\n    * Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR\n    * Uses contraception as detailed below unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below:\n\n      * Uses a penile\u002Fexternal condom plus nonparticipant of childbearing potential who is not currently pregnant and should also be advised of the benefit for that partner to use an additional method of contraception, as a condom may break or leak\n      * Note: Participants capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use penile\u002Fexternal condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate\n    * Contraceptive use by participants capable of producing sperm should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed\n* Participants assigned female sex at birth:\n\n  * A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a person of childbearing potential (POCBP) OR\n    * Is a POCBP and:\n\n      * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:\n\n        * Nemtabrutinib: 1 month\n        * Rituximab: 12 months\n      * The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n    * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for urine test) or 72 hours (for serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive\n    * Abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention with nemtabrutinib\n    * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy\n* Patients with gastrointestinal dysfunction and\u002For clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting or any other condition that will interfere significantly with drug absorption (e.g., gastric bypass surgery, gastrectomy)\n\nExclusion Criteria:\n\n* Evidence of diffuse large B-cell lymphoma (DLBCL) transformation\n\n  * Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL\n* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease\n* Active graft versus host disease\n* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization)\n* Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment\n* Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of study treatment:\n\n  * \\\u003C 10 weeks from completion of any radio- or toxin-immunoconjugates\n  * \\\u003C 4 weeks for immunotherapy\n  * \\\u003C 3 weeks for radiotherapy\n  * \\\u003C 2 weeks for any investigational agent or other anticancer medications\n  * Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg\u002Fday within 7 days of the study treatment administration\n* Inadequate recovery from adverse events related to prior therapy to grade ≤ 1 (excluding grade 2 alopecia and neuropathy)\n* Prior non-covalent BTK inhibitor (prior covalent BTK inhibitors are allowed)\n* Major surgery (under general anesthesia) within 30 days prior to therapy initiation\n* Live vaccine within 30 days\n* Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 2 weeks of the first day of study therapy\n* History of prior malignancy except:\n\n  * Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy\n  * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\n  * Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\n  * Asymptomatic prostate cancer managed with \"watch and wait\" strategy\n  * Superficial bladder cancer\n  * Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening\n* History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding\n* Unstable cardiac disease as defined by one of the following:\n\n  * Acute myocardial infarction (MI) within the past 6 months\n  * NYHA (New York Heart Association) heart failure class III\n  * Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months)\n  * Left ventricular ejection fraction (LVEF) \\\u003C 45%\n* Corrected QT interval (QTc) prolongation (defined as a Fridericia's formula-corrected QT interval \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin)\n* AIDS-defining opportunistic infection in the past 12 months prior to screening\n* History or concurrent condition of interstitial lung disease and\u002For severely impaired lung function\n* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment\n* History of organ transplant\n* Known allergy\u002Fsensitivity to nemtabrutinib or any of the excipients; history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents\n* Clinically significant uncontrolled illness\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* Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma\n* POCBP: Pregnant or breastfeeding\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)",{"count":196,"type":20},35,[95],"This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib in combination with rituximab may be safe, tolerable and\u002For effective in treating patients with marginal zone lymphoma.",[200,201,31,202,203,27,204],"Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma","Gastric Mucosa-Associated Lymphoid Tissue Lymphoma","Nodal Marginal Zone Lymphoma","Splenic Marginal Zone Lymphoma","Extranodal Marginal Zone Lymphoma",[27],"2026-05-12",{"date":208,"type":42},"2026-05-15",{"date":210,"type":20},"2026-12-16",{"date":212,"type":20},"2028-05-02",{"name":214,"class":49},"City of Hope Medical Center",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905","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",{"count":223,"type":20},146,[94,95],"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",[98,99,101,227,100,31,30,228,229],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[98,231,232,233,229,234,235,236,237],"MZL","FL","DLBCL","CDAC","BTK","degrader","BGB-16673","2026-04-14",{"date":240,"type":42},"2026-04-17",{"date":242,"type":42},"2022-05-06",{"date":244,"type":20},"2029-01-31",{"name":246,"class":81},"BeiGene",29,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":16,"minAge":255,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":50},"100400218","phase-1-autologous-stem-cell-transplant-followed-by-polatuzumab-vedotin-in-patients-with-b-cell-non-hodgkin-and-hodgkin-lymphoma-100400218","NCT04491370","Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma","Inclusion Criteria:\n\n* Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.\n* Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse\u002Fprogression having attained a CR, PR, or stable disease post reinduction therapy.\n* Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.\n* Life Expectancy Patients must have a life expectancy of \\> 6 weeks.\n* Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n  1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).\n  2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n* Organ Function Requirements\n\nAdequate Renal Function Defined As:\n\n* Creatinine clearance or radioisotope GFR \\> 60 mL\u002Fmin\u002F1.73 m2 or\n* A serum creatinine based on age\u002Fgender as follows:\n\nAge Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n* 12 to \\\u003C 13 years 1.2 1.2 13 to \\\u003C 16 years 1.5 1.4\n* 16 years 1.7 1.4\n\n  * Adequate Liver Function Defined As:\n\n    * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and\n    * SGOT (AST) or SGPT (ALT) \\\u003C 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma.\n  * Adequate Cardiac Function Defined As:\n\n    * Shortening fraction of \\> 27% by echocardiogram, or\n    * Ejection fraction of \\> 50% by radionuclide angiogram.\n  * Adequate Pulmonary Function Defined As:\n\n    • Normal respiratory rate for age and a pulse oximetry \\> 94% on room air unless due to underlying malignancy.\n  * Peripheral Blood Stem Cell Collection\n\n    • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent.\n\nExclusion Criteria:\n\n* Patient may not have had a prior stem cell transplant\n* Patients must not have active CNS lymphoma\n* Other concurrent investigational agents for treatment of B-cell lymphoma\n* Pregnancy and\u002For active Breast Feeding\n* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.\n* Patient must not have an uncontrolled infection.\n* Patient must not have ≥ Grade 3 neuropathy.","12 Years","70 Years",{"count":258,"type":20},20,[94,95],"Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.",[262,263,102,30,101,31,264,265,266],"B-cell Lymphoma","Burkitt Lymphoma","Transformed Non-Hodgkin Lymphoma","Richter Syndrome","Hodgkin Lymphoma","2026-04-10",{"date":269,"type":42},"2026-04-15",{"date":271,"type":42},"2021-08-01",{"date":273,"type":20},"2027-08-15",{"name":275,"class":49},"New York Medical College",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":284,"type":20},36,[94],"This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[288,289,101,290,291,292,293,30,31,294,295,296,102,297,298,299,300,301,302,303,304,305,306,233,33,307],"B Cell Lymphoma","NHL, Adult","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","High-grade B-cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","Waldenstrom Macroglobulinaemia","2026-04-08",{"date":238,"type":42},{"date":311,"type":42},"2024-11-01",{"date":313,"type":20},"2028-12",{"name":315,"class":81},"Verismo Therapeutics",5,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":16,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":328,"briefSummary":329,"conditions":330,"keywords":334,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"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":327,"type":20},32,[94,95],"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.",[331,297,28,29,31,30,101,102,296,263,300,332,333],"B-cell Acute Lymphoblastic Leukemia","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[335,336,27],"CD19-positive","Leukemia","2026-03-24",{"date":339,"type":42},"2026-03-30",{"date":341,"type":42},"2025-05-30",{"date":343,"type":20},"2031-09",{"name":345,"class":81},"Vironexis Biotherapeutics Inc.",9,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":356,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":50},"100518113","phase-1-cd79b-19-car-t-cells-in-non-hodgkin-lymphoma-100518113","NCT06026319","CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma","A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign informed consent form(s)\n* ≥18 years of age at the time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* Diagnosis of histologically or cytologically confirmed relapsed\u002Frefractory (R\u002FR) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive\u002Fbulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and\u002For in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):\n\n  1. Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  2. Marginal Zone Lymphoma (MZL) nodal of extranodal:\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  3. Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).\n\n     1. R\u002FR disease after 2 or more prior lines of therapy OR\n     2. Relapsed following autologous SCT, OR\n     3. Ineligible for autologous SCT.\n  4. Mantle cell lymphoma\n\n     1. R\u002FR disease as defined by disease progression after last regimen (including autologous SCT) OR\n     2. Refractory disease as defined as failure to achieve a CR to last regimen.\n     3. Prior therapy must include:\n\n        * Anthracycline or bendamustine-containing chemotherapy AND\n        * Anti-CD20 monoclonal antibody therapy AND\n        * BTKi therapy (progression does not have to be documented on BTKi).\n* Subjects must have measurable disease according to appropriate disease specific criteria.\n* Adequate absolute lymphocyte count (ALC \\> 100 cells\u002Ful) within one week of apheresis.\n* Adequate bone marrow function defined by absolute neutrophil count (ANC) \\>1000 cells\u002Fmm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \\>50,000 mm3.\n* Left ventricular ejection fraction \\> 40%\n* Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C 1.5 × ULN.\n* Adequate renal function defined by creatinine clearance \\>60 ml\u002Fmin using the Cockcroft-Gault formula.\n* The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nInclusion Criteria for treatment (Initiating Lymphodepletion\u002FCell Infusion):\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy\n* Oxygen saturation \\>92% on room air while awake\n* No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.\n\nInfusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that these issues resolve in that time frame.\n\nThe above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).\n\nExclusion Criteria for Leukapheresis for Parts A and B:\n\n* Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.\n* Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).\n* No bispecific T cell engagers within 6 months of leukapheresis.\n* No bendamustime within 6 months of leukapheresis.\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.\n* Ongoing systemic immunosuppression for acute and\u002For chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.\n* Presence of active CNS disease\n* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and\u002For recent significant traumatic injury.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.\n* Subjects with history of a new pulmonary embolism (PE) \u002Fdeep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.\n\nAdditional Exclusion Criteria for Leukapheresis for Part B, Arm B.2:\n\n* Prior CD19-directed cellular therapy.",{"count":355,"type":20},24,[94],"This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed\u002Frefractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells.\n\nThis research study involves the study drugs:\n\n* CD79b-19 CAR T cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[359,290,291,30,31,102,300,296,360,101],"Non-hodgkin Lymphoma","Grade 3b Follicular Lymphoma",[362],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-13",{"date":365,"type":42},"2026-03-16",{"date":367,"type":42},"2023-10-26",{"date":369,"type":20},"2028-01-01",{"name":371,"class":49},"Marcela V. Maus, M.D.,Ph.D.",{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":50},"100555301","phase-2-rituximab-plus-venetoclax-in-front-line-marginal-zone-lymphoma-100555301","NCT06510309","Rituximab Plus Venetoclax in Front Line Marginal Zone Lymphoma","A Phase II Study Using Rituximab Plus Venetoclax in the Front Line Treatment of Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed Marginal Zone Lymphoma\n* Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm or spleen \\> 13 cm\n* Patients with intestinal MALT lymphoma must have disease that is detectable by EGD or colonoscopy with biopsy\n* Patients with gastric MALT lymphoma must be h. pylori negative. Patients who are h. pylori positive are allowed if they have failed a trial of h. pylori eradication\n* Patients with gastric MALT lymphoma who are h. pylori negative or who relapsed\u002Frefractory disease after h. pylori eradication must be ineligible form have refused or failed gastric radiation therapy\n* Age ≥18 years\n* ECOG performance status ≤1\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Hemoglobin ≥8.0 g\u002FdL\n  * absolute neutrophil count ≥1,000 cells\u002FmcL (In the event of documented bone marrow involvement, ANC must be ≥1500 cells\u002FmcL)\n  * platelets ≥50,000 cells\u002Fmm3\n  * total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (In patients with Gilberts disease or documented liver involvement, total bilirubin \\\u003C 3 X ULN will be allowed)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C 3 × institutional ULN unless elevation is caused by liver involvement with MZL\n  * Creatinine within institutional ULN OR creatinine clearance \\>60mL\u002Fmin for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)\n* Ability to understand and the willingness to sign a written informed consent document\n* Patient must be able to swallow pills\n* HIV-positive patients on combination antiretroviral therapy are eligible if their HIV is under adequate control with an antiretroviral regimen that has been stable for \\> 4 weeks, as long as the CD4 count is \\>300. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated\n* Patients with Hepatitis B surface antibody serum positivity due to poor immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible\n\nExclusion Criteria:\n\n* Patients who had prior systemic therapy including rituximab\n* Patients who have had prior radiation therapy, with the following exceptions:\n\n  * Palliative radiotherapy (RT) is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable\u002Fassessable disease as outlined above after completion of RT.\n  * Prior RT for gastric MALT is allowed, but must be completed at least 1 week prior to treatment on this study, and prior to any baseline imaging studies or biopsies. Patients must meet criteria for measurable\u002Fassessable disease as outlined above after completion of RT.\n* Prior treatment with ibrutinib or other BTK inhibitor\n* Patients with h. pylori-associated gastric MALT or stage I\u002FII MZL will be excluded unless they are deemed to be unfit for radiation therapy with curative intent.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with uncontrolled hepatitis B or C or HIV infection are ineligible defined as patients with positive serologies and a detectable viral load by PCR.\n* Patients with Hep B core ab positivity are allowed provided Hep B PCR is undetectable\n* Pregnant women or participants unwilling to adhere to institutional guidelines for highly effective contraception for 12 months after the last dose of rituximab are excluded from this study because of documented risks of rituximab on fetal immunologic development and unknown effects of venetoclax on embryonic development. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued.\n* Received moderate or strong CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of venetoclax.\n* Received moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax.",{"count":380,"type":20},33,[95],"The purpose of this study is to see if the combination of rituximab and venetoclax is effective in treating participants with untreated Marginal Zone Lymphoma (MZL).\n\nThe names of the study drugs involved in this study are:\n\n* Venetoclax (a type of inhibitor)\n* Rituximab (a type of antibody)",[27,31,231],[27,31,231],"2026-03-12",{"date":363,"type":42},{"date":388,"type":42},"2026-02-11",{"date":390,"type":20},"2031-10-01",{"name":392,"class":49},"Gottfried von Keudell, MD PhD",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":416},"100626927","phase-2-exploratory-study-of-orelabrutinib-in-the-treatment-of-early-stage-untreated-mzl-100626927","NCT07441993","Exploratory Study of Orelabrutinib in the Treatment of Early-stage Untreated MZL","Orelabrutinib for the Treatment of Marginal Zone Lymphoma: A Phase II, Multicenter, Open-label Study","MZL-IIT-O","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Patients with histopathologically confirmed stage I\u002FII marginal zone lymphoma;\n3. ECOG performance status score of 0-2;\n4. Major organ functions meeting the following criteria:\n\n   1. Blood tests: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥75g\u002FL; if accompanied by bone marrow involvement, ANC ≥1.0×10\\^9\u002FL, platelets ≥50×10\\^9\u002FL, hemoglobin ≥50g\u002FL;\n   2. Blood biochemistry: Total bilirubin ≤1.5×ULN, AST or ALT ≤2×ULN; serum creatinine ≤1.5×ULN;\n5. Coagulation function: International normalized ratio (INR) ≤1.5×ULN;\n6. Expected survival time ≥12 months;\n7. Voluntary written informed consent signed before trial screening.\n\nExclusion Criteria:\n\n1. Lymphoma involving the central nervous system or transformation to high-grade;\n2. Uncontrolled or significant cardiovascular diseases, including:\n\n   1. New York Heart Association (NYHA) Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose of the study drug, or arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \\\u003C50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, or unclassified cardiomyopathy);\n   3. History of clinically significant QTc interval prolongation, or QTc interval \\>470 ms for females or \\>450 ms for males at screening;\n   4. Subjects with symptomatic coronary artery disease requiring medication;\n   5. Poorly controlled hypertension (failure to achieve target blood pressure after at least one month of lifestyle modification and treatment with three or more antihypertensive drugs, including diuretics, at maximally tolerated doses, or requiring four or more antihypertensive drugs for effective control).\n3. Active bleeding within 2 months prior to screening, or current use of anticoagulants, or investigator-determined clear bleeding tendency;\n4. History of deep vein thrombosis or pulmonary embolism within the past six months;\n5. Urine protein ≥2+ and 24-hour urine protein quantification ≥2 g\u002F24 hours;\n6. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or subjects with total gastrectomy;\n7. Current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or other conditions affecting lung function;\n8. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling to use contraception;\n9. Continuous use of drugs with moderate to strong cytochrome P450 CYP3A inhibition or strong induction effects;\n10. Other conditions deemed by the investigator as unsuitable for participation in this trial.",{"count":171,"type":20},[95],"This is a single-arm, multicenter, prospective, phase II study. The primary objective is to assess the efficacy and safety of orelabrutinib in treatment-naïve patients with marginal zone lymphoma.",[31],[27,406,407],"Marginal zone lymphoma","Orelabrutinib","2026-02-26",{"date":410,"type":42},"2026-03-02",{"date":412,"type":42},"2026-01-05",{"date":313,"type":20},{"name":415,"class":49},"Institute of Hematology & Blood Diseases Hospital, China",14,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":21,"phases":426,"briefSummary":427,"conditions":428,"keywords":429,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":50},"100554888","phase-2-optimize-study---orelabrutinib-combined-with-brg-in-untreated-marginal-zone-lymphoma-mzl-100554888","NCT06504940","Optimize Study - Orelabrutinib Combined With BR\u002FG in Untreated Marginal Zone Lymphoma (MZL)","Orelabrutinib Combined With BR\u002FG Followed by Orelabrutinib Maintenance Therapy for Newly Diagnosed Marginal Zone Lymphoma (MZL): A Prospective ,Multicenter, Clinical Study","Inclusion Criteria:\n\n1. For Cohort A: Age 18-70 years, physical condition assessed by a physician as suitable for chemotherapy; for Cohort B: Age 70 or older or under 70 years of age assessed by a physician as unsuitable for chemotherapy.\n2. Gender is not limited.\n3. Confirmed by histopathology, marginal zone lymphoma including MALT, SMZL, NMZL.\n4. Progression, recurrence after local treatment, or unsuitable for local treatment (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment).\n5. ECOG performance score 0-3 points (if the score is 3 points, the physician needs to assess that the deterioration of physical condition is mainly due to tumor burden).\n6. Indications for treatment (with B symptoms, blood cell decline, bleeding, large mass, rapid progression of tumors, etc.).\n7. Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥75g\u002FL; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥50×10\\^9\u002FL, hemoglobin ≥50g\u002FL. b) Blood biochemistry: Total bilirubin ≤1.5 times the upper limit of normal (ULN), AST or ALT ≤2 times ULN; serum creatinine ≤1.5 times ULN; serum amylase ≤ULN. c) Coagulation function: International normalized ratio (INR) ≤1.5 times ULN.\n8. Life expectancy ≥3 months.\n9. Voluntarily sign a written informed consent form before the trial screening.\n\nExclusion Criteria:\n\n1. Currently or previously have other malignant tumors, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years.\n2. Lymphoma involving the central nervous system or transformation to a higher grade.\n3. Have uncontrollable or significant cardiovascular diseases, including: a) Within 6 months before the first administration of the study drug, there is a history of New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction, or arrhythmias requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) \\<50%. b) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy). c) A history of clinically significant QTc interval prolongation, or a QTc interval \\>470ms in females and \\>450ms in males during the screening period. d) Symptomatic or medication-requiring coronary artery heart disease subjects. e) Subjects with uncontrollable hypertension (despite lifestyle improvements and the use of reasonable, tolerable, and adequate doses of three or more antihypertensive drugs, including diuretics, for more than 1 month, blood pressure is still not at the standard, or it is only effectively controlled when taking four or more antihypertensive drugs).\n4. Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or the investigator believes there is a clear bleeding tendency.\n5. History of deep vein thrombosis or pulmonary embolism within the past six months.\n6. Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction), or subjects who have undergone total gastrectomy.\n7. History of organ transplantation or allogeneic bone marrow transplantation.\n8. Major surgery within 6 weeks before screening or minor surgery within 2 weeks before screening. Major surgery is surgery that uses general anesthesia, but endoscopic examinations for diagnostic purposes are not considered major surgery. Insertion of vascular access devices will be exempt from this exclusion criterion.\n9. Active infection or uncontrolled HBV (positive for HBsAg and\u002For HBcAb with positive HBV DNA titer), positive for HCV Ab, HIV\u002FAIDS, or other serious infectious diseases; define active infection.\n10. Subjects currently with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, etc., that seriously affect lung function.\n11. Previously treated with BTK, BCR pathway inhibitors (such as PI3K, Syk), and BCL-2 inhibitors.\n12. Pregnant, breastfeeding women, and subjects of childbearing age who are unwilling to take contraceptive measures.\n13. Need to continuously take drugs with moderate to severe inhibitory effects on cytochrome P450 CYP3A or strong inductive effects.\n14. Other situations deemed unsuitable for participating in this trial by the investigator.",{"count":425,"type":20},69,[95],"This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.",[31],[430,431,31],"orebrutinib","BTKi","2026-02-24",{"date":434,"type":42},"2026-02-27",{"date":436,"type":42},"2024-06-28",{"date":438,"type":20},"2029-07-08",{"name":440,"class":49},"First Affiliated Hospital of Zhejiang University",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":173,"phases":4,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":50},"100527743","evaluation-of-hypertension-management-and-cardiovascular-adverse-event-prevention-in-patients-with-b-cell-malignancies-undergoing-treatment-with-bruton-tyrosine-kinase-inhibitors-the-halt-study-100527743","NCT06151730","Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study","Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-Cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors (HALT) - A Pilot Study","Inclusion Criteria:\n\n* Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), who are willing to return to Mayo Clinic for ongoing follow-up\n\nExclusion Criteria:\n\n* Patients with known central nervous system (CNS) involvement of their B-cell malignancy",{"count":449,"type":20},100,"This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.",[28,452,101,31,33],"Hematopoietic and Lymphoid System Neoplasm",{"date":434,"type":42},{"date":455,"type":42},"2024-01-05",{"date":457,"type":20},"2026-06-30",{"name":459,"class":49},"Mayo Clinic",{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":21,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":50},"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":469,"type":20},12,[94],"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.",[332,102,30,31,101,263],[474,475,476,477,478,479,480],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","Pirtobrutinib","B Cells","BTK inhibitor","Bruton's tyrosine kinase","2026-02-19",{"date":483,"type":42},"2026-02-23",{"date":485,"type":42},"2025-02-06",{"date":487,"type":20},"2027-07",{"name":489,"class":49},"Medical College of Wisconsin",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":21,"phases":499,"briefSummary":500,"conditions":501,"keywords":506,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":50},"100376822","phase-1-car-2019-t-cells-in-patients-with-relapsed-refractory-b-cell-malignancies-100376822","NCT04186520","CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies","Phase I\u002FII Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","GENERAL INCLUSION CRITERIA FOR ALL PATIENTS\n\n1. Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.\n2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm\\^3.\n3. Magnetic resonance imaging (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 EXCEPT Arm E subjects.\n4. Measurable disease must be documented within four weeks of the time of consent 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 (see separate criteria for CLL and primary\u002Fsecondary CNS lymphoma).\n5. Karnofsky performance score ≥70.\n6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C5 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.\n7. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days.\n8. Platelets≥50,000 with no transfusion within 72 hours.\n9. Adequate renal function, defined as creatinine clearance \\>60 ml\u002Fmin AND serum Cr≤1.5 mg\u002FdL.\n\n   a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure within three months of planned CAR infusion.\n10. Able to provide written informed consent.\n11. Agree to practice birth control during the study.\n12. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n13. Expected survival \\>12 weeks.\n14. Negative urine or serum pregnancy test in females of child bearing potential at study entry.\n15. Meet criteria regarding fertility and contraception.\n16. No contraindication to central line access.\n17. Patient has demonstrated compliance to other therapies.\n\nPhase 1: 3+3 COHORT ELEGIBILITY CRITERIA\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell 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).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria.\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant\n   3. Relapse post-allogeneic transplant\n   4. Patients not previously treated with CAR-T cell therapy\n\nPHASE 1b and 2 COHORT ELEGIBILITY CRITERIA\n\nARM A: Six to nine patient expansion with 8-day manufacturing (Phase 1b)\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant.\n   3. Relapse post-allogeneic transplant.\n   4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy.\n\n   i. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM B: Six to nine patient expansion with 12-day manufacturing (Phase 1b)\n\n1\\. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), 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, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n\n2\\. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n4. Relapse post-anti-CD19 CAR-T cell therapy.\n\ni. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM C: 24 patient cryopreservation 8\u002F12 flexible manufacturing arm\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), 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, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria a. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant b. Relapse post-autologous transplant c. Relapse post-allogeneic transplant d. Relapse post-anti-CD19 CAR-T cell therapy i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort\n\nARM D: Phase 1 and Phase 1b: CLL\n\n1\\. Diagnosis of B-cell CLL or small lymphocytic leukemia (SLL) 2. Failed\u002Fprogressed or been intolerant to two prior lines of therapy one of which MUST be either a covalent BTK inhibitor (e.g. ibrutinib, acalabrutinib, zanabrutinib, etc) or BCL2 inhibitors (e.g. venetoclax or other investigational BCL2) 3. Indication for treatment as defined as any of the following:\n\n1. measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly)\n2. bone marrow involvement with ≥10% CLL involvement\n\nARM E: Phase 1 and Phase1b Relapsed\u002FRefractory Primary or Secondary CNS Lymphoma\n\n1. Diagnosis of diffuse large B cell lymphoma (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, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation) with secondary CNS lymphoma involvement OR primary CNS lymphoma.\n2. For Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy.\n3. Secondary CNS lymphoma relapsed or refractory following at least one line of CNS-directed therapy for treatment of CNS lymphoma.\n\n   1. For patients with secondary central nervous system lymphoma (CNSL) with concurrent systemic lymphoma, the concurrent systemic lymphoma must have relapsed following at least 1 prior line of therapy (which must have included an anti-CD20 monoclonal antibody and an anthracycline)\n4. Measurable CNS disease by either lumbar puncture (LP) with positivity in CNS by flow cytometry or morphology for lymphoma cells OR magnetic resonance imaging (MRI) with enhancing lesions ≥1 cm in size consistent with lymphoma\n5. Must have had prior treatment with high dose methotrexate defined as methotrexate given intravenously at a dose ≥2500 mg\u002Fm\\^2 and either progression\u002Frelapse, stable disease, or intolerance to at least one cycle of treatment.\n\nPhase II Cohort: Mantle Cell Lymphoma\n\n1\\. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously defined and have relapsed, refractory disease as defined as 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 Bruton tyrosine kinase (BTK) inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n5. Relapse post anti-CD19 CAR-T cell therapy.\n\ni. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort.\n\nEXCLUSION CRITERIA (ALL PATIENTS)\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 childbearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. 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.\n5. 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.\n6. Refusal to participate in the long-term follow-up protocol\n7. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)\n\n   a. 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.\n8. 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.\n9. Prior allogeneic CAR T-cell therapy\n10. Previous recipients of autologous CAR-T cell therapy directed at either 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\n11. Anti-CD20 antibody treatment within 4 weeks of cell infusion\n12. Anti-CD19 antibody treatment within 4 weeks of cell infusion\n13. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T 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. Oral chemotherapeutic agents or antibody directed treatment within 7 days of apheresis\n\n    a. BTK inhibitors are allowed until 1-day prior to apheresis and can re-start until 1-day prior to lymphodepletion\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)\u002Fmarginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma)\n\nSPECIAL CRITERIA REGARDING FERTILITY AND CONTRACEPTION\n\nFemale 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 as part of eligibility criteria 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\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months 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","80 Years",{"count":449,"type":20},[94,95],"This is a Phase I\u002FII, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7\u002FIL-15) manufactured chimeric antigen receptor (CAR)-20\u002F19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.",[502,503,504,30,31,102,300,505],"Non Hodgkin Lymphoma (NHL)","Mantle Cell Lymphoma (MCL)","Chronic Lymphocytic Leukemia (CLL)","Central Nervous System Lymphoma",[474,475,476,507],"B-cell Malignancies",{"date":483,"type":42},{"date":510,"type":42},"2020-05-18",{"date":512,"type":20},"2029-02-28",{"name":489,"class":49},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100559397","phase-2-epco-zanu-ritux-for-rr-fl-or-mzl-100559397","NCT06563596","Epco, Zanu, Ritux for R\u002FR FL or MZL","A Phase 2 Study of Epcoritamab, Zanubrutinib, and Rituximab (EZR) for Treatment of Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) or CD20+ MZL (any subtype) (at time of trial entry) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current histologic transformation are excluded.\n* Receipt of at least one prior line of therapy for FL or MZL (with prior treatment including a CD20 monoclonal antibody).\n* Measurable disease, defined as ≥1 measurable nodal lesion (long axis \\>1.5 cm or short axis \\>1.0 cm), or ≥1 measurable extra-nodal lesion (long axis \\>1.0 cm), or spleen \\>13 cm on PET, CT, or magnetic resonance imaging (MRI). For patients with FL, disease should be FDG-avid based on PET. FDG-avid disease is NOT a requirement for patients with MZL.\n* Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:\n\n  * Symptomatic adenopathy\n  * Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC \\\u003C1.5x109\u002FL; absolute neutrophil count \\[ANC\\] \\\u003C1.0x109\u002FL, Hgb \\\u003C10g\u002FdL; or platelets \\\u003C100x109\u002FL)\n  * Constitutional symptoms (defined as persistent fevers \\>100.4 F, shaking chills, drenching night sweats, or loss of \\>10% of body weight within 6 months)\n  * Any nodal or extranodal tumor mass \\>7 cm in maximum diameter\n  * \\>3 nodal sites of involvement \\>3 cm\n  * Local compressive symptoms or imminent risk thereof\n  * Splenomegaly (craniocaudal diameter \\> 16cm on CT imaging)\n  * Clinically significant pleural or peritoneal effusion\n  * Leukemic phase (\\>5x109\u002FL circulating malignant cells)\n  * Rapid generalized disease progression\n  * Renal infiltration\n  * Bone lesions\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)\n* Age ≥18 years.\n* Adequate hematologic and organ function:\n\n  1. Absolute neutrophil count \\> 1.0x109\u002FL unless due to marrow involvement by lymphoma in which case ANC must be \\>0.5x109\u002FL\n  2. Platelets \\> 75 x109\u002FL, unless due to marrow involvement by lymphoma, in which case platelets must be \\>50 x109\u002FL\n  3. Estimated CrCl (based on Cockcroft Gault or MDRD) ≥ 45ml\u002Fmin or ≥ 45ml\u002Fmin\u002F1.73m2\n  4. Total bilirubin \\\u003C 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be \\\u003C 1.5 x ULN\n  5. AST\u002FALT \\\u003C 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST\u002FALT must be \\\u003C5 x ULN\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if it is collected within 90 days and without intervening treatment and the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively-charged glass slides. Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Sponsor-Investigator.\n* Willingness to remain abstinent (1) or to use two effective contraceptive methods that result in a failure rate of \\\u003C1% per year from screening until: (a) at least 12 months after pre-treatment with rituximab, 12 months after the last dose of epcoritamab, or 3 months after the last dose of zanubrutinib, whichever is longer, if the patient is a male or (b) until at least 12 months after pre-treatment with rituximab, 12 months after the last dose of epcoritamab, or 3 months after the last dose of zanubrutinib, whichever is longer, if patient is a female. Examples of contraceptive methods with a failure rate of \\\u003C1% per year include:\n\n  * Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of \\\u003C1% per year. Barrier methods must always be supplemented with the use of a spermicide.\n\n    1. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. In contrast, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of \\>10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for lymphoma-related symptom palliation or for prophylaxis (i.e., IV contrast allergy) is allowed, in which case patients should be off steroids prior to treatment start.\n* Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.\n* Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).\n* Presence of HCV antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (NOTE: the limit of detection for HCV RNA must have a sensitivity of \\\u003C 15 IU\u002FmL). Subjects who received treatment for HCV that was intended to eradicate the virus and who have an undetectable HCV RNA may participate without serial HCV RNA screening. Other patients may participate if they are willing to undergo every 3-month monitoring for HCV reactivation.\n* Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with positive hepatitis B serologies with undetectable HBV DNA (NOTE: the limit of detection for HBV DNA must have a sensitivity of \\\u003C 20 IU\u002FmL) are permitted in the trial but should receive prophylactic antiviral therapy (i.e. entecavir) and undergo every 3 month HBV DNA monitoring.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring antimicrobial therapy at trial enrolment or significant infections within 2 weeks of study treatment initiation.\n* Subject has a known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or has had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n  * No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n  * Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n* Prior history of another malignancy (except for non-melanoma skin cancer, in situ cervical or breast cancer, or Gleason 6 prostate cancer managed with observation) unless disease free for at least 2 years OR unless the likelihood of relapse is very low in the opinion of the treating physician.\n* Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period. Vaccination with live vaccines within 28 days of the first dose of study treatment is prohibited.\n* Patients who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.\n* Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary\u002Fperipheral artery bypass graft, cardiac arrhythmia (CTCAE grade 3 or higher), or cerebrovascular accident. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. Uncontrolled hypertension as indicated by ≥ 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mm Hg and diastolic blood pressure \\> 105 mm Hg at screening.\n* Patients with 1) New York Heart Association Class III or IV heart failure or known ejection fraction of \\\u003C45%, 2) MI within 6 months prior to screening, 3) unstable angina within 3 months before screening, or 4) history of clinically significant arrhythmias within 6 months of screening (eg sustained Vtach, Vfib, torsades de pointes).\n* Inability to comply with protocol mandated restrictions.\n* Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.\n* Prior solid organ or allogeneic stem cell transplantation.\n* History of known or suspected hemophagocytic lymphohistiocytosis (HLH).\n* History of clinically significant 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.\n\n  • Patients with a remote history of, or well controlled, autoimmune disease who meet above criteria may be eligible to enroll after consultation with the Sponsor-Investigator.\n* Inability to tolerate anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.\n* Known central nervous system involvement\n* Neuropathy \\> grade 1(based on CTCAE grading)\n* Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab.\n* Treatment with an investigational drug within 4 weeks prior to the first dose of study treatment.\n* Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks prior to the first dose of study treatment.\n* Participants who require warfarin or other vitamin K antagonists for anticoagulation. Other anticoagulants including direct oral anticoagulants (i.e. apixaban, rivaroxaban) and low-molecular weight heparin are allowed.\n* Participants who are known at the time of study entry to require concomitant treatment with any medications or substances that are strong CYP3A inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome.\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusions or other medical interventions. Requires ongoing treatment with warfarin or warfarin derivatives.\n* Prior exposure to a BTK inhibitor\n* A limited number of patients with BsAb-refractory disease will be permitted to enroll in each cohort (see section 2.5.3). After this limit is reached, patients with BsAb-refractory disease will be excluded. BsAb-refractory disease will be defined as failing to achieve an objective response to a prior CD3xCD20 BsAb or relapse\u002Fprogression within 6 months of last dose of CD3xCD20 BsAb.\n* Screening 12-lead ECG showing a baseline QTcF (Fridericia's correction) \\> 480 msec.\n* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n* Major surgery ≤ 4 weeks before the first dose of study treatment or planned during study.",{"count":522,"type":20},45,[95],"The purpose of this study is to determine how effective and safe the combination of epcoritamab, zanubrutinib, and rituximab is in treating participants with relapse or refractory Follicular Lymphoma (FL) or marginal zone lymphoma (MZL).\n\n* The names of the study drugs involved in this research study are:\n* Epcoritamab (a type of antibody)\n* Zanubrutinib (a type of Bruton tyrosine kinase inhibitor)\n* Rituximab (a type of monoclonal antibody)",[30,27,99,526,527,31],"Relapsed Lymphoma","Refractory Lymphoma",[30,27,99,526,527,31],"2026-02-17",{"date":481,"type":42},{"date":532,"type":42},"2025-01-21",{"date":534,"type":20},"2030-03-01",{"name":536,"class":49},"Reid Merryman, MD",3,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":21,"phases":547,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":562},"100595189","phase-3-a-study-of-reduced-dose-radiation-therapy-for-people-with-b-cell-lymphomas-100595189","NCT07029217","A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas","A Prospective Phase III Study Comparing Standard Radiotherapy (24 Gy) With a PET REsponse-guided Very Low Dose (4 Gy) Staged Radiotherapy Strategy for Potentially Curable, Indolent B-cell Lymphomas","Inclusion Criteria: (Arms 1\\&2)\n\n* Patients must be diagnosed with a follicular lymphoma or marginal zone lymphoma. Of note, there are now two widely-utilized pathology classification criteria used for mature B-cell lymphomas, the World Health Organization (WHO) 5th Edition Classification of Lymphoid Neoplasms and the International Consensus Classification (ICC) of Mature Lymphoid Neoplasms. Either criteria is acceptable and for the purposes of this protocol, the following diagnoses are included:\n\n  * Follicular lymphoma\n\n    * WHO 5th Edition\n\n      * Classic follicular lymphoma (cFL)\n      * Follicular lymphoma with uncommon features (uFL)\n      * Pediatric type follicular lymphoma\n      * Duodenal type follicular lymphoma\n    * ICC\n\n      * Follicular lymphoma, grades 1-2 or 3A\n      * BCL2 rearrangement negative, CD23 positive follicle center lymphoma\n      * Pediatric type follicular lymphoma\n      * Duodenal type follicular lymphoma\n  * Marginal zone lymphoma\n\n    * WHO 5th Edition and ICC\n\n      * Nodal marginal zone lymphoma\n      * Pediatric nodal marginal zone lymphoma\n      * Extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT)\n* Patients must have stage I or II disease (with stage I defined as involvement of one nodal region and stage II as two or more nodal regions involved on the same side of the diaphragm)\n* Patients should be newly diagnosed or previously observed with no prior lymphoma-directed therapy\n* If the patient is referred for localized gastric MALT lymphoma, there should be documented negative H. Pylori testing within 6 months prior to proposed radiotherapy\n* Age at the time of enrollment of ≥18 years\n* Patients must be able to start radiation within 2 months from time of randomization\n\nExclusion Criteria:\n\n* Prior radiation to site(s) needing treatment\n* Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria)\n* Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma\n* Patient has cutaneous only iNHL defined as primary cutaneous B-cell lymphoma, primary cutaneous follicle center lymphoma, cutaneous marginal zone lymphoma or unspecified indolent lymphoma of the skin\n* Gross total resection of all disease\n* Tumor size measuring ≥5 cm in maximum diameter on any modality diagnostic imaging\n* Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study",{"count":546,"type":20},375,[62],"The researchers are doing this study to find out whether a very low dose of radiation therapy (VLDRT) is an effective treatment for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and works as well as the standard dose of radiation therapy. The researchers will see if VLDRT works against cancer in the area that is currently affected by cancer and if the therapy prevents new spots of lymphoma from developing. The researchers will also compare VLDRT with the standard dose of radiation therapy to see if VLDRT causes fewer side effects.\n\nRadiation therapy uses beams of intense energy to kill cancer cells. Standard doses of radiation therapy can cause short- and long-term side effects. Researchers think VLDRT may be as effective as standard doses, and, because VLDRT uses less radiation, researchers think VLDRT may cause fewer side effects than standard doses.",[30,31],[551,552,553],"Stage I-II","Radiotherapy","25-089","2026-02-12",{"date":529,"type":42},{"date":557,"type":42},"2025-06-09",{"date":559,"type":20},"2028-06",{"name":561,"class":49},"Memorial Sloan Kettering Cancer Center",7,{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":583,"locationsCount":585},"100422047","phase-1-study-of-oral-administration-of-lp-168-in-patients-with-relapsed-or-refractory-b-cell-malignancies-100422047","NCT04775745","Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.","A Phase I, Multicenter, Open-Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-168 in Subjects With Relapsed or Refractory B-cell Malignancies.","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria:\n\n* Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies.\n* Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma.\n* Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows:\n\n  * Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin using 24-hour CrCl OR Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \\> 1.5 × ULN, per discussion between the Investigator and the Medical Monitor).\n* Subjects must have adequate bone marrow independent of growth factor support per local laboratory reference range at screening as follows:\n\n  * Absolute Neutrophil Count (ANC) ≥1000\u002FuL;\n  * An exception is for subjects with an ANC\\\u003C1000\u002FuL and bone marrow heavily infiltrated with underlying disease (approximately 60% or more) may use growth factor to achieve the ANC eligibility criteria per discussion between the Investigator and the Medical Monitor.\n  * Platelet count ≥ 50,000\u002FµL - OR - Platelet count ≥ 20,000\u002F µL if thrombocytopenia is clearly due to CLL disease under study (per Investigator discretion)\n  * Hemoglobin ≥8.0g\u002FdL, and can be achieved by transfusion\n\nExclusion Criteria:\n\nA subject will not be eligible for study participation if he\u002Fshe meets any of the following criteria.\n\n* Subject has received any of the following therapies within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of study drug, or has not recovered to ≤ Grade 1 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy (other than alopecia):\n\n  * Any anti-cancer therapy including chemotherapy, biologic or immunotherapy, radiotherapy, etc;\n  * Any investigational therapy, including targeted small molecule agents.\n  * For CLL subjects who come off BCR antagonists (BTK inhibitors, PI3K inhibitors, etc.) treatment, allow washout for 2 days as these subjects progress quickly after treatment discontinuation and then remain eligible (steroids may be given during these two days to allow disease control).\n* Subjects who require immediate cytoreduction. However, subjects may receive up to two days of steroids for symptoms of impending organ impairment and remain eligible.\n* Subject has received the following medications or therapies within 7 days prior to the first dose of study drug:\n\n  * Steroid therapy (at dosages equivalent to prednisone \\>20 mg\u002Fday) for anti-neoplastic intent (except as noted in exclusion criteria #3);\n  * Cytochrome P450, family 3, subfamily A (CYP3A4) strong inhibitors and strong CYP2C8 inducers\u002Finhibitors.\n  * Potent CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.\n* Subjects require treatment with systemic acid-reducing agents including H-2-receptor antagonists and proton pump inhibitors with the following exceptions:\n\n  * Proton pump inhibitors should be discontinued at least 7 days prior and held throughout the study\n  * If concurrent use of an H2 blocking agent is necessary, it must be administered only between 2 and 3 hours after the dose of LP-168. If not taken during this time, the dose of H2 blocking agents should not be taken again until 2-3 hours after the next dose of LP-168.\n  * If concurrent use of a local antacid is necessary, it must be administered 2 or more hours before and\u002For 2 or more hours after the dose of LP-168.\n* Subject has significant screening electrocardiogram (ECG) abnormalities including. 2nd degree AV block type II 3rd degree block, Grade 2 or higher bradycardia, and corrected QT interval (QTc) ≥ 480ms.\n* Serum amylase \\> 1.5 × ULN or serum lipase \\> 1.5 × ULN.\n* Subject has any history of Richter's transformation for Phase 1a portion of the trial.\n* Subjects who have undergone autologous\u002Fallogeneic hematopoietic stem cell transplantation (HSCT) therapy within 90 days of the first dose of LP-168, or patients on immunosuppressive therapy post-HSCT at the time of Screening, or currently with clinically significant graft-versus-host disease (GVHD) as per treating physician (Patients in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks. The use of topical steroids and\u002For up to 20 mg\u002Fday prednisone or equivalent systemic steroids for ongoing GVHD is permitted.\n* Subject has a history of other active malignancies other than B-cell malignancies within the past 3 years prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the cervix uteri;\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n* Subject requires anticoagulation with Warfarin.",{"count":571,"type":20},60,[94],"This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.",[575,33,30,102,101,31,576],"CLL\u002FSLL","Hairy Cell Leukemia","2026-02-10",{"date":579,"type":42},"2026-02-13",{"date":581,"type":42},"2021-07-19",{"date":185,"type":20},{"name":584,"class":81},"Newave Pharmaceutical Inc",4,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":21,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":50},"100430312","phase-2-acalabrutinib-and-obinutuzumab-for-the-treatment-of-previously-untreated-follicular-lymphoma-or-other-indolent-non-hodgkin-lymphomas-100430312","NCT04883437","Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas","An Open-Label Phase 2 Trial of Acalabrutinib Plus Obinutuzumab in Patients With Untreated, Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n* Men and women \\>= 18 years of age\n* Patients will need to have one of the following clinical scenarios:\n\n  * Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria\n  * Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard front-line treatment approaches\n  * Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor burden by GELF criteria or who are unable\u002Funwilling to receive more intensive front-line treatment\n  * Previously untreated mantle cell lymphoma who would otherwise be appropriate candidates for watchful waiting OR who have symptomatic disease but are not candidates for or decline standard induction approaches\n* Patients with previously untreated low tumor burden FL (criterion above) must have measurable and\u002For assessable disease defined as at least one involved lymph node or extranodal disease site that measures \\>= 1.5cm in greatest diameter\n* Patients who meet inclusion criteria above are eligible as long as they meet one of the following criteria for measurable\u002Fassessable disease:\n\n  * At least one involved lymph node or extranodal disease site measuring \\> 1.5cm in greatest diameter\n  * Pathologically-confirmed bone marrow or peripheral blood involvement that can be reassessed for response\n  * Pathologically confirmed splenic or extranodal involvement with at least one known site of disease remaining after diagnostic biopsy that can be reassessed (i.e., patients with splenic marginal zone lymphoma who complete splenectomy and have no other detectable disease would not be eligible)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Woman of childbearing potential (WOCBP) and men enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation, and for at least 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab, whichever is longer. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women of childbearing potential must have a negative serum or urine pregnancy test prior to starting therapy\n* Willing and able to participate in all required evaluations and procedures in this study protocol\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information\n\nExclusion Criteria:\n\n* The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma\n* Confirmed active or prior central nervous system disease\n* Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone lymphoma such as hepatitis C or H pylori)\n\n  * A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and steroids must be discontinued (or tapered to =\\\u003C 10mg prednisone or equivalent) no later than 3 days after initiation of study treatment. Patients in the low tumor burden FL cohort may not receive corticosteroids as an anti-lymphoma therapy at any time before starting treatment\n* Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for \\>= 2 years or which will not limit survival to \\\u003C 5 years\n* Clinically significant cardiovascular disease such as symptomatic ventricular arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. Note: Subjects with controlled, asymptomatic atrial fibrillation can enroll on study if deemed appropriate by the investigator\n* Has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication\n* Known history of human immunodeficiency (HIV) or any active significant infection (e.g., bacterial, viral, or fungal) within 14 days of cycle 1. Patients with uncomplicated viral or bacterial infections that are being managed with oral antibiotics and\u002For supportive care alone are eligible\n* Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components\n* Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)\n* Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura)\n* Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening\n* Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with proton pump inhibitors (e.g, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study\n* History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug. Patients with a transient ischemic attack which has resolved and for which there are no ongoing symptoms are eligible\n* Major surgical procedure within 28 days of first dose of study drug (not including a diagnostic procedure to make the lymphoma diagnosis). Note: If a subject 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* Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo deoxyribonucleic acid (DNA) PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible and have completed appropriate anti-viral treatment. Those who are hepatitis C PCR positive will be excluded. Anti-viral therapy for patients with hepatitis-C associated marginal zone lymphoma will not be considered a prior anti-lymphoma treatment\n* Absolute neutrophil count (ANC) \\\u003C 1,000\u002FmcL\n* Platelet count \\\u003C 50,000\u002FmcL (Unless felt to be related to underlying disease)\n* Total bilirubin \\>= 1.5 x the upper limit of normal (ULN). Isolated bilirubin \\> 1.5 x ULN is permitted if the direct proportion is \\\u003C 35%\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 2.5 x ULN\n* Creatinine clearance =\\\u003C 40 mL\u002Fmin\u002F1.73m\\^2\n* Breastfeeding or pregnant\n* Concurrent participation in another therapeutic clinical trial",{"count":594,"type":20},49,[95],"This phase II trial studies the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and obinutuzumab may kill more cancer cells.",[598,599,600,601,32,602,101,31],"Grade 1 Follicular Lymphoma","Grade 2 Follicular Lymphoma","Grade 3a Follicular Lymphoma","Indolent Non-Hodgkin Lymphoma","Lymphoproliferative Disorder","2026-02-05",{"date":605,"type":42},"2026-02-09",{"date":607,"type":42},"2021-09-03",{"date":609,"type":20},"2027-01-15",{"name":611,"class":49},"Emory University",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":21,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":50},"100543011","phase-2-rituximab-and-zanubrutinib-in-patients-with-indolent-b-cell-lymphomas-100543011","NCT06350318","Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas","A Phase 2 Open-Label, Multicenter Study of Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas","Inclusion Criteria:\n\n* Cohort A: Previously untreated MZL. Prior therapy with H. Pylori antibiotic therapy or hepatitis C antiviral therapy are allowed on Cohort A.\n* Cohort B: Previously untreated FL\n* Pathological confirmation of lymphoma: availability of archival tissue confirming diagnosis of MZL (cohort A) or FL (cohort B). Availability of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens from within past 18 months from screening and pathological diagnosis confirmed by a pathologist at the participating site or willingness of the participant to undergo a fresh tumor biopsy if adequate archival tissue not available is required. This includes:\n* MZL (Cohort A):\n\n  1. Nodal MZL requiring systemic therapy\n  2. Splenic MZL requiring systemic therapy\n  3. Extra-nodal marginal zone lymphoma:\n\n     1. Non-gastric\u002Fnon-cutaneous MZL requiring systemic therapy.\n     2. Cutaneous MZL will be eligible only if they have pathologically confirmed extra-cutaneous disease.\n     3. Gastric MZL only if advanced stage disease requiring systemic therapy (e.g., stage IIE, II2, IV- supradiaphragmatic nodal or disseminated extranodal disease such as bone marrow or additional extra nodal sites.\n* FL (Cohort B):\n\n  a. Pathological grade 1, 2, or 3a based on the World Health Organization (WHO 2008) classification of tumors of hematopoietic and lymphoid tissue.\n\n  1\\. Please note, grade 3B are excluded.\n* All participants must have disease requiring systemic therapy rather than local radiation (ie, stage II only if not eligible for radiation therapy or with stage III\u002FIV).\n* All participants should have measurable disease. Measurable disease is defined as a lymph node or tumor mass that is ≥ 1.5 cm in at least one dimension by CT or the CT portion of the PET\u002FCT.\n* Documentation of CD20+ status.\n* All participants must have an indication for therapy such as: symptoms attributable to lymphoma, threatened end-organ function, or cytopenia secondary to lymphoma.\n* All participants must be 18 years of age or older.\n* All participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* All participants must be able to swallow whole pills.\n* All participants must have the ability and willingness to comply with the requirements of the study protocol.\n* All female participants who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).\n* All female participants of childbearing potential must have a negative serum pregnancy test upon study entry.\n* All male and female participants of reproductive potential who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \\[IUDs\\], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy. Female participants of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of 30 days after last dose of zanubrutinib or 12 months after last dose of rituximab, whichever is longer. Male participants are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception in combination with other methods described above during the study treatment period and for ≥ 30 days after the last dose of zanubrutinib, or 12 months after the last dose of rituximab, whichever is longer.\n* All participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Prior therapy for lymphoma including chemotherapy or immunotherapy. Participant may have received corticosteroids but should be off them 5 days prior to study entry.\n* Prior exposure to a BTK inhibitor.\n* Known prior significant hypersensitivity to rituximab (not including infusion reactions).\n* Prior history of malignancies unless the patient has been disease free for ≥ 2 years. Exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapy.\n* Participants with evidence of large B cell transformation or other aggressive histology (such as large cells seen on biopsy or high PET avidity in a single node seen on PET scan) are not eligible.\n* Known central nervous system (CNS) involvement by lymphoma.\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).\n* Concomitant use of warfarin or other Vitamin K antagonists.\n* Requires ongoing treatment with a moderate or strongCYP3A inhibitor or inducer.\n* Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks before the start of Cycle 1.\n* Known infection with human immunodeficiency virus (HIV).\n* Viral Hepatitis:\n\n  1. Participants with active hepatitis B defined by hepatitis B surface antigen positivity or core antibody positivity in the presence of detectable serum hepatitis B DNA viremia are not eligible for this study.\n  2. Participants with a positive hepatitis B core antibody but with negative hepatitis B DNA may be considered for participation, but must agree to receive appropriate hepatitis B antiviral therapy while on rituximab and have hepatitis B DNA monitored with real-time PCR by the treating physician. These patients should be referred to a hepatologist or gastroenterologist for appropriate monitoring and management.\n  3. Hepatitis C: Patients with positive hepatitis C serology unless HCV RNA is confirmed negative by PCR.\n* Vaccination with a live vaccine ≤ 28 days prior to the start of treatment.\n* Participants should not have a history of uncontrolled seizures.\n* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment on the study.\n* Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg at screening.\n* Participants should not have a stroke or intracranial hemorrhage within last 6 months.\n* Participants may not have had major surgery within 28 days of enrollment, or minor surgery within 7 days of enrollment. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.\n* Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.",{"count":620,"type":20},43,[95],"The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).",[30,31,624],"B-Cell Lymphoma",[624,30,31],"2026-02-03",{"date":603,"type":42},{"date":629,"type":42},"2024-04-19",{"date":631,"type":20},"2029-03",{"name":633,"class":49},"H. Lee Moffitt Cancer Center and Research Institute",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":21,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":469},"100413867","phase-1-a-novel-vaccine-eo2463-as-monotherapy-and-in-combination-for-treatment-of-patients-with-indolent-non-hodgkin-lymphoma-100413867","NCT04669171","A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma","A Global Multicenter Phase 1\u002F2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma","SIDNEY","Inclusion Criteria:\n\n1. For inclusion in Cohorts 1 and 4 patients should have relapsed\u002Frefractory, biopsy-proven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and have received at least one prior line of treatment. For inclusion in Cohort 4b the above applies except that patients with FL, and not patients with MZL, will be eligible for enrollment.\n2. For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, and not be in need of standard of care therapy according to the assessment of the treating physician.\n3. For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by GELF criteria and be in need of therapy according to the assessment of the treating physician.\n4. Patients with an age ≥ 18 years old.\n5. Patients who are human leukocyte antigen (HLA)-A2 positive.\n6. Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.\n7. Males or non-pregnant, non-lactating, females.\n8. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.\n9. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Patients treated with dexamethasone \\> 2 mg\u002Fday or equivalent (i.e. 13 mg\u002Fday of prednisone, or 53 mg\u002Fday of hydrocortisone) within 14 days before the first EO2463 administration, unless required to treat an adverse event.\n2. Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.\n3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).\n4. Patients with prior exposure to EO2463.\n5. Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion\u002Fexclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration.\n6. Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.\n7. Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy.\n8. Patients with abnormal laboratory values.\n9. Patients with persistent Grade 3 or 4 toxicities.\n10. Uncontrolled central nervous system (CNS) metastasis.\n11. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.\n12. Patients with clinically significant disease.\n13. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).\n14. Patients with history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n15. Pregnant and breastfeeding patients.\n16. Patients with history or presence of human immunodeficiency virus and\u002For potentially active hepatitis B virus\u002Fhepatitis C virus infection.",{"count":643,"type":20},80,[94,95],"The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and\u002For rituximab in patients with indolent NHL",[30,31],[30,31,69,70,648],"Peptide-based immunotherapy","2026-01-28",{"date":651,"type":42},"2026-01-30",{"date":653,"type":42},"2021-07-05",{"date":655,"type":20},"2034-05-30",{"name":657,"class":81},"Enterome",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":21,"phases":667,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":537},"100423334","phase-2-mosunetuzumab-with-lenalidomide-augmentation-as-first-line-therapy-for-follicular-and-marginal-zone-lymphoma-100423334","NCT04792502","Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","BrUOG 401: A Phase 2 Study of Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.\n2. Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients \\\u003C18 years of age, they are excluded from this study.\n3. Histologically confirmed diagnosis of:\n\n   * follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or\n   * marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL\u002FMZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis.\n4. Agreement to provide, if available, lymphoma tissue for correlative analyses.\n5. At least one bi-dimensionally measurable nodal lesion, defined as \\>1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \\>1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria.\n6. No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed.\n7. Indication to start systemic therapy for lymphoma:\n\n   * Patients with FL must meet one of the GELF criteria:\n\n     * any mass ≥7 cm (except spleen);\n     * at least 3 nodes \\>3 cm in diameter;\n     * symptomatic spleen enlargement;\n     * local symptoms or compromise of normal organ function due to tumor mass;\n     * presence of ascites or pleural effusion;\n     * presence of B symptoms (fever, night sweats, or unintentional weight loss of \\>10% over ≤6 months);\n     * serum lactate dehydrogenase or beta-2-microglobulin above upper limit of normal;\n     * cytopenias due to underlying lymphoma (i.e., absolute neutrophil count \\\u003C1.0 × 109\u002FL, hemoglobin \\\u003C10 g\u002FdL, and\u002For platelet count \\\u003C100 × 109\u002FL).\n   * Patients with MZL must have an indication to start therapy as assessed by the investigator.\n8. Performance status ECOG 0, 1, or 2.\n9. Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly):\n\n   * hemoglobin ≥9 g\u002FdL,\n   * absolute neutrophil count ≥1.0 x 109\u002FL,\n   * platelet count ≥75 x 109\u002FL.\n10. Glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73m2 using the Mayo Quadratic Formula.\n11. The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because lenalidomide used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n12. Agreement to enroll in and comply with all local requirements of the REVLIMID® (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS®) program for the purpose of lenalidomide acquisition.\n\nExclusion Criteria:\n\n1. Grade 3b follicular lymphoma or transformed lymphoma.\n2. Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma.\n3. Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation.\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n5. Known NYHA class 3\u002F4 congestive heart failure, LVEF \\\u003C40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.\n6. Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.\n7. History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering \\\u003C10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for \\>12 months prior to registration.\n8. Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment using \\\u003C10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first treatment; a brief course of palliative corticosteroids at higher doses (prednisone up to 100 mg daily, for up to 7 days) is allowed, but must be completed at least 7 days before the first dose of mosunetuzumab.\n9. Any of the following conditions:\n\n   * active bacterial infection requiring antibiotics\n   * known or suspected chronic active Epstein Barr virus (CAEBV) infection\n   * history of hemophagocytic lymphohistiocytosis (HLH)\n   * confirmed progressive multifocal leukoencephalopathy (PML)\n   * known active EBV or CMV viremia\n   * positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total\u002FIgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to take entecavir or tenofovir, and undergo periodic DNA testing\n   * positive hepatitis C virus (HCV) antibody, unless a negative polymerase chain reaction (PCR) for HCV is documented\n   * positive test for HIV.\n10. Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab dose or anticipation that such a live, attenuated vaccine will be required during the study.\n11. Current or past history of CNS disease, including stroke, epilepsy, or CNS vasculitis, or an advanced neurodegenerative disease; with the exception of: stroke \\>2 years before registration without any residual neurologic deficits and no subsequent transient ischemic attacks; history of epilepsy with no seizures for \\>2 years and not using any antiepileptic therapy; well-controlled Parkinson's disease (with no need for a significant medication adjustment for \\> 6 months).\n12. History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or another malignancy treated curatively with a documented remission \\>2 years before registration are eligible.\n13. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the first dose of mosunetuzumab.\n14. Clinically significant liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n15. Any major surgery within 4 weeks before the first dose of mosunetuzumab, other than lymph node biopsy for diagnosis.\n16. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol.\n17. Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab:\n\n    * AST or ALT \\>3x ULN\n    * total bilirubin \\>2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only)\n    * INR\\>1.5 x ULN without anticoagulation\n    * PTT or APTT \\>1.5x ULN in the absence of lupus anticoagulant.\n18. Any radiation therapy within 2 weeks prior to first dose of mosunetuzumab.\n19. Pregnancy, breast-feeding, or prisoner status. Women of childbearing potential must have a negative pregnancy test within 2 weeks before first dose of mosunetuzumab, and must undergo repeat pregnancy testing during each cycle of lenalidomide therapy (see Inclusion Criterion 11).",{"count":666,"type":20},52,[95],"BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).",[30,31,262],"2025-12-27",{"date":672,"type":42},"2025-12-30",{"date":674,"type":42},"2022-07-14",{"date":676,"type":20},"2027-08-31",{"name":678,"class":49},"Brown University"]