[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"waldenstrom-macroglobulinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:waldenstrom-macroglobulinemia":33},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,51,75,100,135,158,184,221,247,282,312,332,375,399,421,443,463,484,526,548,572,595,617,645,666],{"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":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100427022","phase-2-testing-the-combination-of-venetoclax-and-rituximab-in-comparison-to-the-usual-treatment-ibrutinib-plus-rituximab-or-zanubrutinib-alone-for-waldenstroms-macroglobulinemialymphoplasmacytic-lymphoma-100427022","NCT04840602","Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia\u002FLymphoplasmacytic Lymphoma","A Phase II Randomized Study Comparing BTK Inhibitors (Ibrutinib Plus Rituximab or Zanubrutinib Alone) vs. BCL-2 Inhibitor (Venetoclax) and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) \u002F Lymphoplasmacytic Lymphoma (LPL)","Inclusion Criteria:\n\n* Participants must have had a confirmed diagnosis of Waldenstrom's macroglobulinemia (WM)\u002Flymphoplasmacytic lymphoma (LPL). Participants must have measurable disease as determined by IgM protein quantification.\n\n  * IgM Spike: ≥ 500 mg\u002FdL (≥ 5 g\u002FL)\n  * Extramedullary disease: The manifestation of a lymphoid mass outside of the bone marrow, resulting in enlargement in extramedullary organs such as the lymph nodes or spleen. Note: all participants must have measurable IgM spike, but are not required to have extramedullary disease\n* Testing to establish baseline disease status must be performed within 28 days prior to registration\n* Participants must have at least one of the criteria to require therapy for WM including:\n\n  * Anemia\n  * Thrombocytopenia\n  * Neuropathy related to WM\n  * Symptomatic hyperviscosity or serum viscosity levels ≥ 4.0 centipoises\n  * WM associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms\n\n    * Constitutional symptoms can be described as:\n\n      * Unintentional weight loss \\>= 10% within the previous 6 months prior to screening\n      * Fevers higher than 100.5 degrees Fahrenheit (F) or 38.0 degrees Celsius (C) for 2 or more weeks prior to screening without evidence of infection\n      * Night sweats for more than 1 month prior to screening without evidence of infection\n      * Clinically relevant fatigue which is not relieved by rest due to WM\n* Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug will be excluded from the study. If such participants can be safely switched to an alternative agent, then the participants will be eligible to enroll\n* Participants must not have had prior systemic therapy. Prior therapy with rituximab will be allowed as long as the last rituximab dose was at least 6 months prior to registration\n* Participants must be \\>= 18 years of age\n* Participants must have history and physical exam within 28 days prior to registration\n* Participants must have Zubrod performance status =\\\u003C 2\n* Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \\>= 30 mL\u002Fmin. Values must be obtained within 14 days prior to registration\n* Total bilirubin =\\\u003C 1.5 x IULN (institutional upper limit of the norm) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\\\u003C 3 x IULN (within 14 days prior to registration)\n* Alkaline phosphatase =\\\u003C 3 x IULN (within 14 days prior to registration)\n* Platelet count \\>= 50,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration\n* Hemoglobin \\>= 7.0 g\u002FdL (within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration\n* Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration\n* Participants must be able to take and swallow oral medication (capsules) whole. Participants may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n* Participants must not be intolerant to rituximab\n* Participants must not have known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding localized skin and nail bed fungal infections) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) 4 weeks prior to registration\n* Participants must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). Hepatitis C virus (HCV) testing is only required if clinically indicated or if the participant has a history of HCV\n* Participants must not consume grapefruit, Seville oranges or starfruit within 3 days prior to the first dose of venetoclax\n* Participants must not be pregnant or nursing because venetoclax has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" e.g., implants, injectables, combined oral contraceptives, some intrauterine devices \\[IUDs\\], complete abstinence, or sterilized partner) and a barrier method (e.g., condom, cervical ring, sponge, etc.). This also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures throughout the study and for at least 30 days after competition of therapy\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years or watchful waiting is appropriate in the opinion of the treating physician. Also, malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence within 5 years, is permissible consideration of eligibility for this trial\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* As a part of the Oncology Participant Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* CROSSOVER CRITERIA: Participants must have been registered and received treatment in the IR\u002FZ or VR arm and must show progression of disease at any time during cycles 3-24\n* CROSSOVER CRITERIA: In case of transformation to intermediate or high-grade lymphoma or development of Bing-Neel syndrome the participants will not undergo registration step 2 crossover and will be taken off the study\n* CROSSOVER CRITERIA: Participants must have Zubrod performance status =\\\u003C 2\n* CROSSOVER CRITERIA: Participants must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) \\>= 30 mL\u002Fmin. Values must be obtained within 14 days prior to registration\n* CROSSOVER CRITERIA: Participants must have no evidence of marked hepatic dysfunction on any recent liver function tests within 14 days prior to registration\n* CROSSOVER CRITERIA: Platelet count \\>= 50,000 cells\u002Fmm\\^3 (without within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration\n* CROSSOVER CRITERIA: Hemoglobin \\>= 7.0 g\u002FdL (without within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration\n* CROSSOVER CRITERIA: Absolute neutrophil count (ANC) \\>= 1,000 cells\u002Fmm\\^3 (without within 14 days prior to registration)\n\n  * NOTE: Transfusion and\u002For growth factor support is allowed up to 7 days prior to registration",{"count":59,"type":20},92,[61],"PHASE2","This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab or zanubrutinib in treating patients with previously untreated Waldenstrom's macroglobulinemia\u002Flymphoplasmacytic lymphoma. Ibrutinib 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called BTK, which may help keep cancer cells from growing. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib with rituximab or zanubrutinib alone.",[32,33],"2026-06-27",{"date":66,"type":42},"2026-06-30",{"date":68,"type":42},"2022-01-05",{"date":70,"type":20},"2028-03-31",{"name":72,"class":73},"National Cancer Institute (NCI)","NIH",135,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":4,"leadSponsor":98,"locationsCount":50},"100127162","natural-history-study-of-monoclonal-b-cell-lymphocytosis-mbl-chronic-lymphocytic-leukemiasmall-lymphocytic-lymphoma-cllsll-lymphoplasmacytic-lymphoma-lplwaldenstrom-macroglobulinemia-wm-and-splenic-marginal-zone-lymphoma-smzl-100127162","NCT00923507","Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Lymphoplasmacytic Lymphoma (LPL)\u002FWaldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)","-INCLUSION CRITERIA:\n\n1. Diagnosis of CLL\u002FSLL will be made according to the updated criteria of the NCI Working Group.\n\n   * on treatment or previously treated\n   * requiring or nearing first-line treatment\n\n   OR\n\n   Diagnosis of LPL\u002FWM. LPL is defined as the presence of an intertrabecular pattern of bone marrow infiltration by small lymphocytes showing plasmacytoid\u002Fplasma cell differentiation. WM, comprising \\>95% of LPL cases, describes the clinical syndrome of LPL associated with an IgM monoclonal gammopathy of any concentration. The remaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is required for diagnosis\n2. Age greater than or equal to 18 years.\n3. ECOG performance status of 0-2.\n4. Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1\\. None","110 Years",{"count":83,"type":20},1000,"OBSERVATIONAL","Background\n\nThe development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)\u002Fsmall lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)\u002FWaldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.\n\nObjectives\n\nStudy the history of MBL\u002FCLL\u002FSLL\u002FLPL\u002FWM\u002FSMZL in patients prior to and after treatment. Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.\n\nEligibility:\n\n* Diagnosis of CLL\u002FSLL and on treatment\u002Fpreviously treated\u002Fnearing treatment\n* Diagnosis of LPL\u002FWM\n* As of February 5, 2025, patients with MBL and SMZL will no longer be enrolled.\n* Age greater than or equal to 18 years.\n* ECOG performance status of 0-2.\n\nDesign\n\nPatients are typically followed every 6 to 24 months in the clinic and have blood drawn. Patients may be asked to undergo additional testing, including bone marrow biopsy and aspiration, lymph node biopsy, positron emission tomography, and CT and MRI scans. Some of these tests (e.g., blood draw) may be required to monitor CLL\u002FSLL and LPL\u002FWM. Other tests (e.g., lymph node biopsy) may not be clinically indicated, but patients may be asked to undergo these procedures for research purposes.\n\nNo treatment will be administered on this study. If a patients requires treatment for their cancer, available NIH clinical trials and alternative treatment options will be discussed with the patient.\n\n...",[33,32,87,29,88],"Monoclonal B-Cell Lymphocytosis","CLL (Chronic Lymphocytic Leukemia)",[90,91,92,93,94,27],"Chronic Lymphocytic Leukemia (CLL)","Monoclonal B Cell Lymphocytosis","Small Lymphocytic Lymphoma (SLL)","Natural History","Leukemia",{"date":66,"type":42},{"date":97,"type":42},"2008-05-29",{"name":99,"class":73},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100600733","phase-1-a-study-of-ly4152199-in-participants-with-previously-treated-b-cell-malignancies-baffrontier-1--100600733","NCT07101328","A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )","BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies","BAF_FRontier-1","Inclusion Criteria:\n\n* Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.\n* Participants with select tumor types must have measurable or assessable disease as defined below:\n\n  * Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.\n  * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing.\n* Must be able to comply with inpatient\u002Foutpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.\n* Must have adequate organ function.\n\nPhase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed\u002Frefractory B-cell malignancy.\n\nPhase 1 Dose Optimization (Cohort B) Participants\n\n\\- Must have histologically confirmed relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).\n\nExclusion Criteria:\n\nAll Participants\n\n* Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL).\n* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.\n* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.\n* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.\n* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).\n* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.\n* History of autoimmune disease\n* Significant cardiovascular disease\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process\n* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).\n* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).\n* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody).\n* Pregnant and\u002For planning to breastfeed during the trial or within 90 days of the last dose of study intervention.\n* Known hypersensitivity to any component or excipient of LY4152199.",{"count":109,"type":20},215,[111],"PHASE1","The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.",[114,115,116,117,118,33,119],"Lymphoma, Non-Hodgkin","B-cell Lymphoma","Lymphoma, Large B-Cell, Diffuse","Lymphoma, Follicular","Lymphoma, B-cell Marginal Zone","Lymphoma, Mantle Cell",[121,122],"B- cell activating factor receptor (BAFFR)","Bispecific antibody","NOT_YET_RECRUITING","2026-06-19",{"date":126,"type":42},"2026-06-23",{"date":128,"type":20},"2026-06",{"date":130,"type":20},"2029-09",{"name":132,"class":133},"Eli Lilly and Company","INDUSTRY",50,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100610774","phase-2-a-study-of-pirtobrutinib-venetoclax-and-rituximab-in-people-with-waldenstrms-macroglobulinemia-wmlymphoplasmacytic-lymphoma-lpl-100610774","NCT07231952","A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)\u002FLymphoplasmacytic Lymphoma (LPL)","A Phase II Study of Time-limited Combination of Pirtobrutinib, Venetoclax, and Rituximab in Treatment Naïve Patients With Waldenström's Macroglobulinemia (WM) \u002F Lymphoplasmacytic Lymphoma (LPL) (PRoVen)","Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Histologically confirmed treatment naive WM\u002FLPL\n* Patients must have measurable disease as defined by at least one lymph node ≥1.5 cm and\u002F or IgM levels \\> 0.5gm\u002Fdl quantified by using densitometry on serum protein electrophoresis (SPEP) or quantitative nephelometry.\n* Participants must have at least one of the established criteria to require therapy for WM, including anemia, thrombocytopenia, neuropathy related to WM, symptomatic hyperviscosity or serum viscosity levels greater than 4.0 centipoises, WM-associated glomerulonephritis or renal disease, bulky disease, or constitutional symptoms\n* ECOG performance status ≤2\n* Platelet count ≥ 50,000 cells\u002Fmm3, independent of transfusions within 7 days of screening assessment\n* Hemoglobin ≥ 8 g\u002FdL, unless due to disease involvement in which case ≥ 7 g\u002FdL, independent of transfusions within 7 days of screening assessment\n* Absolute neutrophil count \\>1000 cells\u002FmcL, independent of growth factor support within 7 days of screening assessment\n* Total bilirubin \\\u003C 1.5 x upper normal institutional limits. In patients with Gilbert's disease total bilirubin up to 3x ULN will be allowed\n* AST(SGOT)\u002FALT(SGPT) \\\u003C 3 x institutional upper limit of normal unless elevation is caused by liver involvement with WM in which case AST and ALT may be ≤ 5 x ULN\n* Creatinine within normal institutional limits OR Creatinine clearance \\>40 mL\u002Fmin for patients with creatinine levels above institutional normal (by Cockcroft-Gault estimate or 12-24h creatinine clearance measurements)\n* 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 ULN\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patient must be able to swallow pills\n* Patients with Hepatitis B surface antibody serum positivity due to prior immunization, as well as those with Hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible.\n* Willingness of participants of reproductive potential and their partners to observe highly effective birth control methods for the duration of treatment and for 1 year following the last dose of study treatment\n\nExclusion Criteria:\n\n* Prior\u002FConcomitant Therapy: Participants must not have had prior systemic therapy.\n* Medical Conditions\n\n  * Major surgery within 4 weeks prior to start of treatment\n  * History of bleeding diathesis\n  * Patients who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor.\n  * NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)\n  * History of stroke or intracranial hemorrhage within 6 months of start of treatment\n  * History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of start of treatment or presence of any of the following, regardless of prior SCT and\u002For CAR-T therapy timing:\n  * active graft versus host disease (GVHD);\n  * cytopenia from incomplete blood cell count recovery post-transplant;\n  * need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n  * ongoing immunosuppressive therapy (\\> 20 mg prednisone or equivalent daily).\n* Significant cardiovascular disease defined as:\n\n  * unstable angina or acute coronary syndrome within the past 2 months prior to start of treatment\n  * history of myocardial infarction within 3 months prior to start of treatment or\n  * documented LVEF by any method of ≤ 40% in the 12 months prior to start of treatment\n  * ≥ Grade 3 NYHA functional classification system of heart failure\n  * Uncontrolled or symptomatic arrhythmias\n* Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33).\n\n  * Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n  * Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n* Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK- inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n  * Hepatitis B virus (HBV):\n  * Patients with positive hepatitis B surface antigen (HBsAg) are excluded.\n  * Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before start of treatment.\n  * Patients who are HBV DNA PCR positive will be excluded.\n  * 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 start of treatment. Patients who are hepatitis C RNA positive will be excluded.\n* Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.\n* Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment.\n* Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug.\n* Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n* Active second malignancy unless in remission and with life expectancy \\> 2 years.\n* Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist.\n* Vaccination with live vaccine within 28 days prior to start of treatment\n* Other Exclusions\n\n  * Have a known hypersensitivity to any of the excipients of Pirtobrutinib or to any intended study medications.\n  * Participants who require ongoing use or received a moderate or strong CYP3A inducer, moderate or strong CYP3A inhibitor, P-gp inhibitor within 7 days prior to the first dose of study drug",{"count":19,"type":20},[61],"The purpose of this study is to find out if the combination of pirtobrutinib, venetoclax, and rituximab is an effective treatment for participants with Waldenström's macroglobulinemia (WM)\u002Flymphoplasmacytic lymphoma (LPL)",[33,32],[33,32,147,148],"Memorial Sloan Kettering Cancer Center","25-149","2026-06-16",{"date":151,"type":42},"2026-06-17",{"date":153,"type":42},"2025-11-11",{"date":155,"type":20},"2028-04-11",{"name":147,"class":49},9,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100559224","phase-2-zanubrutinib-bendamustine-rituximab-prev-untreated-wm-100559224","NCT06561347","Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM","A Phase 2 Multicenter Study of the Combination Zanubrutinib, Bendamustine, and Rituximab in Previously Untreated Waldenström Macroglobulinemia (ZEBRA Trial)","ZEBRA","Inclusion Criteria:\n\n* Clinicopathological diagnosis of waldenström macroglobulinemia (WM) per the second international workshop on waldenström macroglobulinemia (IWWM2) criteria\n* Presence of any MYD88 and CXCR4 mutation status, including MYD88 L265P mutation plus CXCR4 wild type, MYD88 L265P mutation plus CXCR4 mutation, or MYD88 wild type\n* Meeting criteria for treatment per IWWM2 criteria. At least one of the following:\n\n  * Constitutional Symptoms (at least one of the following)\n\n    * Recurrent fever\n    * Night sweats\n    * Fatigue\n    * Weight loss\n  * Progressive or symptomatic lymphadenopathy or splenomegaly\n  * Hemoglobin ≤ 10 g\u002FdL\n  * Platelet count ≤ 100 k\u002FuL\n  * Hyperviscosity syndrome\n  * Symptomatic peripheral neuropathy\n  * Systemic amyloidosis\n  * Renal insufficiency\n  * Symptomatic cryoglobulinemia or cold agglutinemia\n* Treatment naive; must have not received any prior systemic therapy for WM\n* Participants with suspected or symptomatic hyperviscosity (e.g. nosebleeds, headaches, blurred vision) must undergo plasmapheresis prior to treatment initiation.\n* Adults age ≥18\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence1 from heterosexual intercourse during treatment and for at least 1 week after the last dose of zanubrutinib or at least 12 months after the last dose of rituximab, whichever is later. FCBP must be referred to a qualified provider of contraceptive methods if needed. Also, FCBP must have a pregnancy check with a negative serum pregnancy test obtained 28 days prior to and confirmed by C1D1.\n* Men must agree to use a condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy 1) while participating in the study; and 2) for at least 1 week following the last dose of zanubrutinib.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥500\u002FmcL believed to be caused by WM bone marrow involvement. Growth factors are not permitted \\\u003C14 days prior to C1D1.\n  * Platelets ≥30,000\u002FmcL believed to be caused by WM bone marrow involvement. Platelet transfusions are not permitted \\\u003C14 days prior to C1D1.\n  * Hemoglobin ≥ 7 g\u002FdL. RBC transfusions are not permitted \\\u003C14 days prior to C1D1.\n  * Total bilirubin ≤ 1.5 X institutional ULN, or ≤3 x institutional ULN with documented liver metastases and\u002For Gilbert's Disease\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X institutional ULN with documented liver metastases\n  * Creatinine clearance ≥30 mL\u002Fmin using the Cockcroft-Gault formula\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Any serious medical condition, laboratory abnormality, uncontrolled intercurrent illness, or psychiatric illness\u002Fsocial condition that would prevent the participant from signing the informed consent form\n* Female participants who are pregnant, breastfeeding, or planning to become pregnant or breastfeed while enrolled in this study\n* Participants with known CNS involvement by WM\n* Participants with known history of Human Immunodeficiency Virus (HIV)\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n  * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.\n  * Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.\n* Concurrent systemic immunosuppressant therapy. Systemic steroids at doses \\\u003C20mg prednisone per day are permitted.\n* Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).\n* Concurrent administration of warfarin or warfarin derivatives.\n* Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.\n* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the Investigator and the Sponsor makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required.\n* Major surgery within 4 weeks of first dose of study drug.\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, or history of spontaneous bleeding requiring blood transfusion or other medical intervention. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.\n* Participants with inability to swallow pills.\n* Inability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of the study participation.\n* Any uncontrolled or significant cardiovascular disease defined as:\n\n  * Unstable angina within 3 months before screening, or\n  * History of myocardial infarction within 6 months prior to planned start of zanubrutinib, or\n  * Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of zanubrutinib; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during Screening should be performed in selected patients as medically indicated, or\n  * Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or\n  * Uncontrolled or symptomatic arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n* Participants with a known hypersensitivity to any of the excipients of Zanubrutinib, Rituximab, or Bendamustine.\n* Participants with a history of non-compliance to medical regimens, which will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.\n* Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancers.\n* Severe or debilitating pulmonary disease.\n* Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.\n* Ongoing use of a strong CYP3A inducer.",{"count":167,"type":20},56,[61],"The purpose of this study is to determine the very good partial response (VGPR) or better rate in participants with Waldenström macroglobulinemia (WM).\n\nThe names of the study drugs involved in this study are as follows: zanubrutinib, bendamustine, and rituximab.",[33],[172,173],"MW","Untreated","2026-06-05",{"date":176,"type":42},"2026-06-08",{"date":178,"type":42},"2024-12-20",{"date":180,"type":20},"2027-12-01",{"name":182,"class":49},"Massachusetts General Hospital",5,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":196,"conditions":197,"keywords":201,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100194258","phase-3-a-long-term-extension-study-of-pci-32765-ibrutinib-100194258","NCT01804686","A Long-term Extension Study of PCI-32765 (Ibrutinib)","A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study","CAN3001","Inclusion Criteria:\n\n* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib\n* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks\n* Agrees to protocol-defined use of effective contraception\n* Negative blood or urine pregnancy test at screening\n\nExclusion Criteria:\n\n* Requires anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with strong cytochrome P450 (CYP)3A4\u002F5 inhibitors, unless previously approved by sponsor\n* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study",{"count":193,"type":20},700,[195],"PHASE3","The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.",[28,29,198,30,199,33,200],"Mantle Cell Lymphoma","Diffuse Large B-cell Lymphoma","Chronic Graft Versus Host Disease",[202,203,204,205,206,207,208,209,210,211],"Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Mantle cell lymphoma","Follicular lymphoma","Diffuse large B-cell lymphoma","PCI-32765","Ibrutinib","Bruton's tyrosine kinase inhibitor","IMBRUVICA","JNJ-54179060","2026-06-04",{"date":174,"type":42},{"date":215,"type":42},"2013-09-09",{"date":217,"type":20},"2029-12-31",{"name":219,"class":133},"Janssen Research & Development, LLC",175,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100622734","phase-2-study-to-assess-change-in-disease-activity-of-oral-venetoclax-in-adult-participants-with-recurring-relapsed-or-refractory-rr-waldenstrm-macroglobulinemia-wmlymphoplasmacytic-lymphoma-lpl-100622734","NCT07387471","Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R\u002FR) Waldenström Macroglobulinemia (WM)\u002FLymphoplasmacytic Lymphoma (LPL)","A Phase 2 Study of Venetoclax Monotherapy in Japanese Subjects With Relapsed or Refractory Waldenström Macroglobulinemia\u002FLymphoplasmacytic Lymphoma","Inclusion Criteria:\n\n* Documented diagnosis of Waldenström macroglobulinemia(WM) \u002Flymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health Organization (WHO) classification and\u002For documented clinicopathological diagnosis of WM in accordance with the consensus panel of the second International Workshop on WM (IWWM).\n* At least one prior standard therapy for WM\u002FLPL.\n* Measurable disease, defined as follows:\n\n  * WM type LPL population: Immunoglobulin M (IgM) \\>= 500 mg\u002FdL per central laboratory (approximately 14 participants)\n  * Non-IgM type LPL population or IgM \\\u003C 500 mg\u002FdL: A measurable node having a longest diameter (LDi) greater than 1.5 cm, or a measurable extranodal disease having a LDi greater than 1.0 cm, according to contrast-enhanced computed tomography (CT) scan. (up to 2 participants)\n* Requires systemic anti-cancer treatment for WM\u002FLPL, according to the investigator.\n* Eastern Cooperative Oncology Group Performance Status \\\u003C = 2\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* History of prior exposure to venetoclax or BCL-2 targeted therapy.\n* Uncontrolled active systemic infection.\n* Known bleeding disorders (e.g., von Willebrand's disease or hemophilia).",{"count":229,"type":20},14,[61],"Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)\u002FLPL receiving venetoclax.\n\nVenetoclax is being investigated in the treatment of WM\u002FLPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM\u002FLPL will be enrolled in the study at approximately 20 sites in Japan.\n\nParticipants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[33,32],[33,32,234,235,236],"Venetoclax","Venclexta","Cancer","2026-05-27",{"date":239,"type":42},"2026-05-29",{"date":241,"type":42},"2026-03-17",{"date":243,"type":20},"2028-07",{"name":245,"class":133},"AbbVie",17,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":256,"conditions":257,"keywords":265,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100229822","study-of-mgus-smoldering-myeloma-early-mds-and-cll-to-assess-molecular-events-of-progression-and-clinical-outcome-100229822","NCT02269592","Study of MGUS, Smoldering Myeloma, Early MDS and CLL to Assess Molecular Events of Progression and Clinical Outcome","Study of Precursor Hematological Malignancies to Assess the Relationship Between Molecular Events of Progression and Clinical Outcome","Inclusion Criteria:\n\n* Patients with Known or Suspected Precursor Hematological Cancer\n* Including the following subgroups of diseases:\n\n  * Early MDS, including pathologically-confirmed MDS (IPSS Low\u002FInt-1; IPSS-R Very Low\u002FLow) and idiopathic cytopenias of undetermined significance (ICUS);\n  * Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM);\n  * Monoclonal B cell lymphocytosis (MBL);\n  * Early stage asymptomatic low-grade lymphomas; or\n  * Other precursor conditions or clonal genetic abnormalities of the blood\u002Fbone marrow that do not meet criteria for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes).\n* Patients must be at least 18 years of age to participate in this research.\n* Inclusion of Women and Minorities -- In accordance with NIH guidelines, women and members of minority groups and their subpopulations will be included in this protocol.\n\nExclusion Criteria:\n\n* Patients with Known or Suspected Precursor Hematological Cancer are NOT EXCLUDED\n* Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study.",{"count":255,"type":20},10000,"Blood cancers occur when the molecules that control normal cell growth are damaged. Many of these changes can be detected by directly examining parts of the cancer or cells in blood. Several alterations that occur repeatedly in certain types of blood cancers have already been identified, and these discoveries have led to the development of new drugs that target those alterations. More remain to be discovered.\n\nSome of these abnormalities include alterations in genes. Genes are the part of cells that contain the instructions which tell the investigators bodies how to grow and work, and determine physical characteristics such as hair and eye color. Genes are composed of DNA letters that spell out these instructions. Studies of the DNA molecules that make up the genes are called \"molecular\" analyses. Molecular analyses are ways of reading the DNA letters to identify errors in genes that may contribute to an increased risk of cancer or to the behavior of the cancer cells. Some changes in genes occur only in cancer cells. Others occur in the genes that are passed from parent to child. This research study will examine both kinds of genes. The best way to find these genes is to study large numbers of people. The investigators expect that as many 1000 individuals will enroll in this study.\n\nThis research study is trying to help doctors and scientists understand why cancer occurs and to develop ways to better treat and prevent it. To participate in this study the participant must have cancer now, had it in the past, or are at risk of developing cancer. The participant will not undergo tests or procedures that are not required as part of their routine clinical care. The investigators will ask the participant to provide an additional sample from tissue that is obtained for their clinical care including blood, bone marrow, or tissue sample. The investigators will also ask for a gentle scrape of the inside of their cheek, mouthwash or a skin sample to obtain their germline DNA",[258,259,260,261,262,263,264,33],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","Myelodysplastic Syndromes","Hematological Malignancies","B-cell Malignancy, Low-grade","Myelodysplastic Syndrome With Low-grade Lesions","IgG Monoclonal Gammopathy of Uncertain Significance","Smoldering Multiple Myeloma",[266,267,268,33,269,270,264,271],"MGUS","Smoldering Myeloma","Acute Myeloid Leukemia","Monoclonal Gammopathy of Undermined Significance","Monoclonal B cell lymphocytosis","Myelodysplastic syndromes","2026-05-04",{"date":274,"type":42},"2026-05-07",{"date":276,"type":42},"2014-08",{"date":278,"type":20},"2030-09",{"name":280,"class":49},"Dana-Farber Cancer Institute",7,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":229},"100446902","phase-2-efficacy-of-venetoclax-in-combination-with-rituximab-in-waldenstrms-macroglobulinemia-100446902","NCT05099471","Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia","VIWA-1","Inclusion Criteria:\n\n* Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM (IWWM). Histopathology has to be perfomed before randomization but within the last 4 months before start of treatment. In addition, pathological specimens have to be sent to the national pathological reference center prior to randomization for the determination of the mutational status of MYD88 and CXCR4 prior to randomization if the mutational status hasn't been determined before. Pathological reference center must confirm the diagnosis of WM.\n* De novo WM independent of the genotype.\n* Patients must have at least one of the following criteria to start study treatment as partly defined by consensus panel criteria from the Seventh IWWM and ESMO Guideline:\n\n  * Recurrent fever, night sweats, weight loss, fatigue (at least one of them).\n  * Hyperviscosity.\n  * Lymphadenopathy which is either symptomatic or bulky (≥ 5 cm in maximum diameter).\n  * Symptomatic hepatomegaly and \u002F or splenomegaly.\n  * Symptomatic organomegaly and \u002F or organ or tissue infiltration.\n  * Peripheral neuropathy due to WM.\n  * Symptomatic cryoglobulinemia.\n  * Symptomatic Cold agglutinin anemia.\n  * Autoimmune hemolytic anemia and\u002For thrombocytopenia.\n  * Nephropathy related to WM.\n  * Amyloidosis related to WM.\n  * Hemoglobin ≤ 10 g\u002FdL (patients should not have received red blood cells transfusions for at least 7 days prior to obtaining the screening hemoglobin).\n  * Platelet count \\\u003C 100 x 109\u002FL (caused by bone marrow \\[BM\\] infiltration of the lymphoma).\n  * Serum monoclonal protein \\> 5 g\u002FdL, even with no overt clinical symptoms.\n  * IgM serum concentration ≥ 6 g\u002FdL.\n  * and other WM associated relevant symptoms\n* Subject must be ≥ 18 years of age.\n* Life expectancy \\> 3 months.\n* World Health Organization (WHO) \u002F ECOG performance status ≤ 2.\n* Left ventricular ejection fraction ≥ 40% as assessed by transthoracic echocardiogram (TTE).\n* Baseline platelet count ≥ 50x109\u002FL, absolute neutrophil count ≥ 0.75x109\u002FL (if not due to BM infiltration by the lymphoma).\n\n  . Adequate hepatic function per local laboratory reference range as follows:\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0 x ULN.\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).\n* Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n* Women of childbearing potential (WCBP), i.e. fertile, following menarche and until becoming postmenopausal must have negative results for pregnancy test and must agree to use a highly effective method of birth control for the duration of the therapy up to 12 months after end of therapy\n* Men must agree not to father a child for the duration of therapy and 12 months after and must agree to advice their female partner to use a highly effective method of birth control. Males must refrain from sperm donation for the duration of treatment and at least 12 months after the last dose of study medication.\n* Each patient must voluntarily date and sign an informed consent form in the native language of the patient indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n* Affiliation to a social security scheme (relevant for France only).\n\nExclusion Criteria:\n\n* Serious medical or psychiatric illness (especially undergoing treatment) likely to interfere with participation in this clinical study.\n* Subject is known to be positive for HIV.\n* Active severe infection\n* Congenital or acquired severe immunodeficiency not attributed to lymphoma (clinical appearance: recurrent infections, necessity of immunoglobulin substitution therapy, patients after transplantation)\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled systemic infection (viral, bacterial or fungal).\n  * Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* inadequate pulmonary function as demonstrated by DLCO ≤ 65% or FEV1 ≤ 65%.\n* Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n* Uncontrolled diabetes mellitus (as indicated by metabolic derangements and \u002F or severe diabetes mellitus related uncontrolled organ complications).\n* Uncontrolled hypertension.\n* Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina.\n* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months prior to start therapy.\n* Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.\n* Subject has a cardiovascular disability status of New York Heart Association Class \\> 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.\n* History of stroke or intracranial haemorrhage within 6 months prior start of treatment\n* Known pericardial disease.\n* Known interstitial lung disease.\n* Infiltrative pulmonary disease, known pulmonary hypertension.\n* Prior history of malignancies unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following:\n\n  * Basal cell carcinoma of the skin,\n  * Squamous cell carcinoma of the skin,\n  * Carcinoma in situ of the cervix,\n  * Carcinoma in situ of the breast,\n  * Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).\n* Known cirrhosis (meeting child-pugh stage C).\n* Chemotherapy with approved or investigational anticancer therapeutic within 21 days prior to start of therapy\n* Glucocorticoid therapy within 14 days prior to therapy that exceeds a cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids given for anti-neoplastic intent.\n* Treatment with any of the following within 7 days prior to the first dose of study drug:\n\n  * moderate or strong cytochrome P450 3A (CYP3A) inhibitors (such as fluconazole, ketoconazole, and clarithromycin).\n  * moderate or strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, St. John's wort).\n* Contraindication to the active substances or any of the other excipients of the Investigational Medicinal Products as well as to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs.\n* Vaccination with live attenuated vaccines within 4 weeks prior to start of therapy.\n* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor, if consulted, would pose a risk to subject safely or interfere with the study evaluation, procedures or completion.\n* Women who are pregnant as well as women who are breast-feeding and do not consent to discontinue breast-feeding.\n* Participation in another clinical trial within four weeks before start of therapy in this study.\n* No consent for registration, storage and processing of the individual disease-characteristics.\n* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n  * grapefruit or grapefruit products.\n  * Seville oranges (including marmalade containing Seville oranges).\n  * star fruit.\n* Person of legal age who is incapable of comprehending the nature, significance and implications of the clinical trial and of determining his\u002Fher will in the light of these facts",{"count":290,"type":20},80,[61],"In Waldenström's macroglobulinemia (WM) chemotherapy induces only low CR\u002FVGPR rates and response duration is limited. In addition, WM patients are often elderly, partly not tolerating chemotherapy related toxicities. Thus, innovative approaches are needed which combine excellent activity and tolerability in WM. Chemotherapy-free approaches are highly attractive for this patient group. Based on its high activity and favorable toxicity profile in indolent B-NHL such as CLL, Venetoclax was approved for the treatment of this diseases by the FDA and the European Medicines Agency (EMA). First data in relapsed\u002Frefractory WM have documented high activity and low toxicity of Venetoclax also in WM, including patients with prior Ibrutinib treatment or patients carrying CXCR4 mutations. Ibrutinib itself has high activity and a relatively low toxicity profile in WM, but has also major disadvantages: the main disadvantage is the need to apply this drug continuously. Furthermore, Ibrutinib efficacy depends largely on the genotype with a substantial drop in major responses and PFS in the presence of CXCR4 mutations and non-mutated MYD88. In particular the need of continuous treatment for Ibrutinib has prevented that Ibrutinib has become the standard of care outcompeting conventional Rituximab\u002Fchemotherapy. This is reflected in current guidelines such as the NCCN and the ESMO guidelines, which still see immunochemotherapy as a backbone of treatment, largely because of the advantage of a timely fixed application. Data in CLL in the relapsed as well as in the first line setting have convincingly shown that in contrast to Ibrutinib Venetoclax is highly efficient also when used in a timely defined application scheme over 12 months in combination with the anti-CD20 antibody Rituximab. Data documented deep responses including molecular responses and a highly significant advantage over immunochemotherapy in large international Phase III trials, changing the standard of care in this disease.\n\nBased on this the hypothesis is that timely fixed application of the combination of Venetoclax and Rituximab induces significantly superior treatment outcomes compared to chemotherapy and Rituximab (DRC) in patients with treatment naïve WM, regardless of the genotype. A first indication for this assumption in the proposed trial will allow the performance of confirmatory phase 3 trials that might change the standard of care in WM.",[33,294],"Treatment Naive",[296,297,234,298,299,27,300,301,302],"Hematology","Oncology","Rituximab","DRC","NHL","indolent","monoclonal IgM","2026-04-28",{"date":305,"type":42},"2026-05-05",{"date":307,"type":42},"2025-03-21",{"date":309,"type":20},"2033-03",{"name":311,"class":49},"Christian Buske",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":330,"locationsCount":50},"100635112","phase-2-mosunetuzumab-in-combination-with-pirtobrutinib-in-patients-with-relapsed-or-refractory-waldenstrom-macroglobulinemia-mpower-100635112","NCT07548450","Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER)","A Phase II Study of Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER)","MPOWER","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years with documented diagnosis of WM with the definition of measurable disease\n* Subjects who are able to comply with the study protocol.\n* Subjects with relapsed or refractory WM who have received at least one prior line of therapy.\n\n  * Must have received prior treatment with covalent BTK inhibitor or have declined such treatment.\n  * Prior autologous stem cell transplant is permitted if completed ≥ 100 days prior to treatment.\n  * Prior allogeneic transplants are not permitted.\n* Subjects must have an indication for treatment per 2nd International Workshop on WM35\n* ECOG Performance Status ≤ 2\n\n  * Adequate organ function as defined as:\n  * Hematologic:\n\n    * Absolute neutrophil count ≥ 1000\u002Fmm3 independent of G-CSF support, unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case ANC of 750 cells\u002Fmm3 (0.75 x 10\\^9\u002FL) is permissible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n    * Platelet count ≥75,000 cells\u002Fmm3 (≥75 x 10\\^9\u002FL) independent of transfusion support unless there is documented bone marrow involvement in which case platelet count of 50,000 cells\u002Fmm3 (50 x 10\\^9\u002FL) is permissible. Patients must be responsive to transfusion support if given for thrombocytopenia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n    * Hemoglobin of ≥ 8.5 g\u002FdL (≥ 85 g\u002FL) independent of transfusion support unless there is documented bone marrow involvement or splenomegaly with ensuing cytopenia in which case hemoglobin of 7 g\u002FdL (70 g\u002FL) is permissible. Patients must be responsive to transfusion support if given for anemia and patients refractory to transfusion support are not eligible. Also, there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n    * Coagulation: Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN.\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n    * Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula.\n* Participants must adhere to the following sex and contraceptive\u002Fbarrier requirements:\n\n  * If participant is of childbearing potential, they must have a negative pregnancy test\n  * For participants of non-childbearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n  * \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n\n      --≥ 50 years of age:\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 5.4.1 and 5.4.2.\n* Able to swallow oral tablets.\n* Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have recovered to grade 1 or have been determined to be clinically stable per the Investigator.\n* Subject or their legal representative is able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* History of transformation of indolent disease to DLBCL\n* Active or history of CNS lymphoma or leptomeningeal infiltration\n* Prior treatment with a non-covalent BTK inhibitor\n* Prior treatment with CD20-directed bispecific antibody therapy\n* Receiving other investigational agents.\n* Receipt of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study\n\n  * Patients must not receive live, attenuated vaccines (e.g., FluMistâ) while receiving study treatment or after the last dose until B-cell recovery to the normal ranges.\n  * Inactivated influenza vaccination should be given during the influenza season only.\n  * An approved coronavirus disease 2019 (COVID-19) vaccine (messenger RNA \\[mRNA\\], inactivated virus, and replication deficient viral vector vaccines) is allowed, as these are not considered live vaccines.\n* Receipt of systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment £ 10 mg\u002Fday prednisone or equivalent within 2 weeks prior to the first dose of mosunetuzumab\n\n  * Patients who received acute, low-dose, systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B-symptoms) may be enrolled in the study if deemed appropriate by the investigator.\n  * The use of inhaled corticosteroids is permitted.\n  * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n* History of solid organ transplantation\n* History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs) or known sensitivity or allergy to murine products\n* Known active bacterial, viral (including SARS-CoV-2), fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Known or suspected history of macrophage activation syndrome (MAS) \u002F hemophagocytic lymphohistiocytosis (HLH)\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n\n  * Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no significant residual neurologic deficits as judged by the investigator are allowed.\n  * Patients with a history of epilepsy who have had no seizures in the past 1 year while not receiving any anti-epileptic medications are allowed.\n* Clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal absorption of the study drug\n* History of bleeding diathesis\n* Major surgery 4 weeks prior to starting study therapy or participant has not fully recovered from major surgery.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Unstable angina or acute coronary syndrome within 6 months prior to first dose of study therapy.\n    * History of myocardial infarction within 6 months prior to first dose of study therapy\n    * QTc prolongation defined as a QTcF \\> 470 ms.\n  * Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n  * Correction for underlying bundle branch block (BBB) allowed.\n  * Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n\n    ---Left ventricular ejection fraction \\\u003C 40% within 12 months prior to first dose of study therapy.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, social\u002F psychological issues, etc.)\n* Evidence of other clinically significant uncontrolled condition(s) or other clinically significant active disease process which, in the opinion of the investigator, is likely to pose a risk for patient participation.\n* Known HIV infection.\n* Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis\n\n  --Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Participants with positive anti-HBc and negative HBV DNA should be on prophylactic nucleo(t)side analogue therapy to prevent reactivation with serial HBV DNA PCR monitoring Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Known active cytomegalovirus (CMV) infection.\n* History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n\n  * Patients with a remote history of, or well-controlled, autoimmune disease with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator.\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone are eligible.\n  * Patients 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  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency oral corticosteroids within the previous 12 months.\n* Positive SARS-CoV-2 test within 7 days prior to enrollment\n* Substance abuse within 12 months prior to screening\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v 6.0 Grade ≥ 3).\n* Participants taking prohibited medications as described in Section 7.4.10.\n* Subject has received prior standard or investigational anti cancer therapy as specified below:\n\n  * Chimeric antigen receptor T-cell therapy within 60 days prior to Day 1 of Cycle 1.\n  * Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1.\n  * Prior treatment with monoclonal antibodies, chemotherapy, or antibody-drug conjugates within 4 weeks before first mosunetuzumab administration.\n  * Treatment with any anticancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment.\n  * Radiotherapy\n\n    * 14 days for local site radiation therapy\n    * 6 weeks for prior radioisotope therapy\n    * 12 weeks for 50% pelvic or total body irradiation",{"count":7,"type":20},[61],"The purpose of this clinical trial it to test the safety and tolerability of the study drugs mosunetuzumab in combination with pirtobrutinib in patients with relapsed or refractory Waldenstrom's Macroglobulinemia.",[33],"2026-04-16",{"date":326,"type":42},"2026-04-23",{"date":128,"type":20},{"date":329,"type":20},"2035-06",{"name":331,"class":49},"University of Utah",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":183},"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":340,"type":20},36,[111],"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.",[344,345,198,346,347,348,349,30,31,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,33,365],"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","Diffuse Large 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","DLBCL","Waldenstrom Macroglobulinaemia","2026-04-08",{"date":368,"type":42},"2026-04-14",{"date":370,"type":42},"2024-11-01",{"date":372,"type":20},"2028-12",{"name":374,"class":133},"Verismo Therapeutics",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":21,"phases":384,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100555315","phase-2-epcoritamab-in-previously-treated-wm-100555315","NCT06510491","Epcoritamab in Previously Treated WM","A Phase 2 Trial Investigating Epcoritamab in Patients With Previously Treated Waldenstrom Macroglobulinemia (WM)","Inclusion Criteria:\n\n* A diagnosis of lymphoplasmacytic lymphoma\u002FWM that is CD20+ by immunophenotype or immunohistochemistry confirmed by bone marrow biopsy\u002Faspirate (fresh or archival tissue acceptable) at time of most recent progression. All degrees of CD20 positivity will be accepted.\n* Serum IgM level \\>2x upper limit of normal (ULN)\n* Meeting criteria for initiation of treatment per IWWM2 criteria \\[Kyle Semin Oncol 2002\\], including but not limited to hyperviscosity syndrome, peripheral neuropathy, cold agglutinin disease, cryoglobulinemia, amyloidosis, cytopenias due to bone marrow infiltration, symptomatic or bulky lymph nodes, symptomatic splenomegaly, constitutional symptoms not otherwise explained by other causes, signs of organ dysfunction secondary to WM\n* At least one prior line of treatment that was discontinued either due to intolerance or disease progression\n* Prior therapies must have included an anti-CD20 antibody (e.g. rituximab) and a BTK inhibitor (e.g. ibrutinib, zanubrutinib). Patients who received ibrutinib and rituximab in combination as first line therapy will be eligible. BTKi should be stopped to allow a washout period of no less than 4 half-lives prior to epcoritamab.\n* Age ≥18 years\n* ECOG performance status £ 2\n* Life expectancy of greater than 2 years\n* Participants must meet the following organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1000 cells\u002Fmcl (G-CSF allowed)\n  * absolute lymphocyte count ≥200 cells\u002Fmcl\n  * platelets ≥75,000 cells\u002Fmcl OR ≥50,000 cells\u002Fmcl in the presence of bone marrow involvement or splenomegaly (Note: no PLT transfusions within 7 days prior to screening)\n  * hemoglobin ≥ 8 g\u002FdL (transfusion allowed)\n  * total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected\u002Fknown Gilbert's disease total bilirubin up to 3x ULN will be allowed but direct bilirubin must be ≤ 2 x ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤3× institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * creatinine clearance \\>45 ml\u002Fmin (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)\n* Subject does not have an active (PCR-positive) Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. If laboratory evidence for a chronic infection with hepatitis B, close monitoring and prophylactic therapy is required as described in Section 5.4.\n* Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years before registration, the treatment was considered \"curable-intent\", and there is no evidence of disease.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:\n\n  * Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS);\n  * Male partner sterilization (the vasectomized partner should be the sole partner for that patient)\n  * True abstinence (when this is in line with the preferred and usual lifestyle of the patient)\n* Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.\n* A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.\n* Patients with HIV may be enrolled if they are on stable antiretroviral therapy, have an undetectable viral load, and CD4 count \\> 250 cells\u002Fmm3.\n\nExclusion Criteria:\n\n* Participants who have disease that has transformed to aggressive lymphoma\n* Participants with symptomatic or suspected hyperviscosity syndrome or IgM levels greater than 4000 mg\u002FdL who are unable to undergo plasmapheresis to decrease the risk of an IgM flare. Participants who can undergo plasmapheresis will be eligible as long as they undergo the procedure prior to first treatment dose.\n* Participants who are receiving any other investigational agent\n* Washout from prior therapy: BTKi: no less than5 half-lives prior to epcoritamab to prevent BTKi rebound and rituximab: no less than 4 weeks (28 days) from last dose.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) except for alopecia and peripheral neuropathy\n* Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment\n* Uncontrolled underlying cardiac conditions including but not limited to: congestive heart failure grade III or IV (by NYHA) or EF \\\u003C 45%, unstable angina pectoris, acute myocardial infarction \\\u003C 6 months, uncontrolled cardiac arrhythmia\n* History of uncontrolled neurologic condition including but not limited to: seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis\n* Need for supplemental O2 at rest to maintain SaO2\\>92%\n* Chronic immunosuppressive therapy for non-WM-related indication within 28 days of initiation of treatment, including systemic corticosteroids 20 mg\u002Fday or greater prednisone-equivalent\n* Patients with known or suspected CNS involvement or leptomeningeal disease (i.e. BingNeel Syndrome) are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease\n* Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:\n\n  * Premenarchal\n  * Postmenopausal (\\>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \\[FSH\\] level \\>40 IU\u002FL or mIU\u002FmL)\n  * Permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy) Note: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.13.\n* Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab\n* Exposure to a live or a live attenuated vaccine within 4 weeks",{"count":383,"type":20},20,[61],"This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM).\n\nThe names of the study drug involved in this study is:\n\n-Epcoritamab (a type of antibody)",[33,387],"B-Cell Lymphoproliferative Disorder",[33,387],"2026-03-12",{"date":391,"type":42},"2026-03-13",{"date":393,"type":42},"2024-12-06",{"date":395,"type":20},"2027-12-31",{"name":397,"class":49},"Gottfried von Keudell, MD PhD",3,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":16,"minAge":406,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":50},"100628635","phase-2-nemtabrutinib-bortezomib-and-rituximab-for-wm-100628635","NCT07464210","Nemtabrutinib, Bortezomib, and Rituximab for WM","Nemtabrutinib, Bortezomib, and Rituximab for the Treatment of Waldenstrom's Macroglobulinemia (NEBULA)","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\n  1. Confirmed diagnosis of WM in accordance with the consensus panel of the IWWM (per local evaluation), and treatment naïve\n  2. Symptomatic disease meeting at least 1 of the recommendations from the IWWM for requiring treatment.\n  3. Measurable disease defined as serum monoclonal IgM \\> 0.5g\u002FdL.\n  4. Is an individual of any sex\u002Fgender, who are at least 19 years of age on the day of signing informed consent (ICF).\n  5. 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     * Nemtabrutinib: 12 days\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     * 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\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\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\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     * Is not a person of childbearing potential (POCBP) OR\n     * Is a POCBP and:\n     * Uses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% 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), as described in Appendix 3 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     * Nemtabrutinib: 1 month\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 (eg, 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. Additional requirements for pregnancy testing during and after study intervention are in Section X.\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  6. The participant (or legally acceptable representative if applicable) has provided documented informed consent\u002Fassent for the trial.\n  7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n  8. The ability to swallow and retain oral medication.\n  9. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\n     Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg and anti-HBV. Hepatitis B screening tests are not required unless:\n     * Known history of HBV infection\n     * As mandated by local health authority\n  10. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n      • Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\n      Hepatitis C screening tests are not required unless:\n      * Known history of HCV infection\n      * As mandated by local health authority\n  11. Adequate organ function as defined in the following table (Table 5.1.1). Specimens must be collected within 7 days prior to randomization.\n\n      Table 5.1.1 Adequate organ function System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥500\u002FµL a, b Platelets ≥25 000\u002FµL a, b Hemoglobin ≥8 g\u002FdL a, b Renal Creatinine OR Measured or calculated c creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR\n\n      ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n      aGrowth factor and\u002For transfusion support is permissible to stabilize participant prior to study treatment if needed.\n\n      bNo lower limit if cytopenia is related to bone marrow involvement. cCreatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\n      Exclusion Criteria:\n* The participant must be excluded from the study if the participant meets any of the following criteria:\n\n  1. Active HBV\u002FHCV infection.\n  2. Positive for human immunodeficiency virus (HIV).\n  3. Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).\n  4. Active infection requiring systemic therapy, including IV antibiotics during screening. Participants may be rescreened followed completion of IV antibiotic course.\n  5. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n  6. QTc prolongation (defined as a QTcF \\>450 msecs) or other significant ECG abnormalities including second degree AV block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin).\n  7. A history of anaphylaxis or hypersensitivity to investigational products or components of investigational products (nemtabrutinib, bortezomib, rituximab).\n  8. History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.\n  9. History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.\n\n     NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder.\n  10. A POCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  11. Prior use of any BTKi.\n  12. Prior exposure to proteasome inhibitors (bortezomib, ixazomib, carfilzomib).\n  13. Prior exposure to anti-CD20 antibody.\n  14. Currently being treated with the following drugs:\n\n      1. P-gp substrates with a narrow therapeutic index\n      2. CYP3A strong inducers\n      3. CYP3A strong inhibitors NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment. A list of example in vivo substrates for specific CYP enzymes and P-gp is provided in Appendix 5.\n\n      NOTE: Refer to Appendix 5 regarding prohibited concomitant medications and potential drug interactions after participant randomization.\n  15. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.\n\n      Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.\n  16. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n      Note: Refer to Section 5.2.2 for information on COVID-19 vaccines\n  17. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n  18. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n  19. Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications.\n\n      Note: Biopsy and placement of central venous access devices are not considered major surgery.\n  20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","19 Years",{"count":408,"type":20},19,[61],"This is a phase II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of nemtabrutinib in combination with bortezomib and rituximab",[33],"2026-03-05",{"date":414,"type":42},"2026-03-11",{"date":416,"type":20},"2026-06-01",{"date":418,"type":20},"2030-08-01",{"name":420,"class":49},"Seoul National University Hospital",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":430,"studyType":84,"phases":4,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100488437","observational-study-evaluating-the-efficacy-and-safety-of-zanubrutinib-in-participants-with-waldenstrm-macroglobulinemia-100488437","NCT05640102","Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia","A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia","Inclusion Criteria:\n\n* Clinical and definitive histologic diagnosis of WM\n* Measurable disease, as defined by a serum immunoglobulin M (IgM) level \\> 0.5 g\u002FdL at the time of zanubrutinib initiation\n* Started treatment with zanubrutinib, has been treated with zanubrutinib, or is planned to be prescribed zanubrutinib for the treatment of WM\n* Bone marrow specimens with central MYD88 test results of:\n\n  1. Cohort 1: MYD88 L265P mutation; enrollment of TN participants will be stopped in each racial and ethnic participant group when the required numbers of participants in the group are met\n  2. Cohort 2: non-L265P MYD88 mutation(s) and MYD88WT\n\nExclusion Criteria:\n\n* Evidence of disease transformation before the first dose of zanubrutinib\n* Evidence of other non-Hodgkin Lymphoma (NHL) subtypes\n* Prior or concurrent active malignancy ≤ 2 years before the first dose of zanubrutinib, except for malignancies that, in the investigator's opinion, will not obscure the interpretation of safety or efficacy results\n* Concurrent participation in another therapeutic clinical study while receiving zanubrutinib, although the participant may be eligible depending on the status of the interventional study after discussion with the Medical Monitor or designee on an individual basis",{"count":429,"type":20},111,"5 Years","This is a hybrid (retrospective and prospective) non-interventional registry study to further describe the clinical profile of zanubrutinib in Waldenström macroglobulinemia (WM) participants with and without specific mutations and from racial and ethnic minority groups. Data collected from this registry study will be used to better understand the clinical benefit and safety of zanubrutinib for the treatment of participants in these populations.",[33],"2026-03-03",{"date":435,"type":42},"2026-03-04",{"date":437,"type":42},"2023-03-03",{"date":439,"type":20},"2027-12",{"name":441,"class":133},"BeiGene",8,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":452,"conditions":453,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"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":451,"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.",[28,454,198,31,33],"Hematopoietic and Lymphoid System Neoplasm","2026-02-24",{"date":457,"type":42},"2026-02-27",{"date":459,"type":42},"2024-01-05",{"date":66,"type":20},{"name":462,"class":49},"Mayo Clinic",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":483},"100446416","spanish-registry-of-patients-with-igm-monoclonal-gammopathies-100446416","NCT05093153","Spanish Registry of Patients With IgM Monoclonal Gammopathies","Spanish Registry of Patients With Diagnosis of IgM-MGUS, Asymptomatic & Symptomatic Waldenström Macroglobulinemia. Analysis of Clinical and Laboratory Features, Treatment and Outcomes.","PRAME","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients having a confirmed diagnosis of either in the las 30 years:\n* Monoclonal Gammopathy of uncertain significance -IgM\n* Asymptomatic Waldenström's macroglobulinemia\n* Symptomatic Waldenström's macroglobulinemia\n\nExclusion Criteria:\n\n* Other subtypes of Lymphoproliferative diseases.",{"count":83,"type":20},"Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disorder which is defined by bone marrow infiltration by small lymphocytes, lymphoplasmacytoid and plasma cells together with the presence of a detectable monoclonal immunoglobulin M (IgM).The clinical presentation of WM is variable. Symptoms can be related to tumor infiltration, or they can be related to the monoclonal IgM component. The therapeutic options are heterogeneous and there are no well-established in both first line or relapse\u002Frefractory settings. In Spain, the incidence of MGUS-IgM and WM in the last decade is unknown.\n\nThe aims of this retrospective, observational, multicentric study is:\n\n* To develop a national registry of patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance -IgM in Spain in the past 30years.\n* To evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with WM\n* To help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in Spain.\n\nMethods:\n\nThe investigators will collect data from the patient clinical files after prior Informed Consent providing from patients with diagnosis of MGUS-IgM and WM in the past 30 years in Spain, according to the WHO classification of lymphoid tumors (2008) revised in 2016. Data from patients not able to provide IC (i.e., already dead patients) will be included only after the permission of the ethics review board.\n\nThe collected data will be included in a database of the Spanish Myeloma and Lymphoma Intergroup (SMALI) team created ad-hoc by the Spanish Society of Hematology and Hemotherapy (SEHH). Each principal investigator in each center will conduct their technical supervision. The evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the International Waldenström's Macroglobulinemia Group.",[33],"2026-02-19",{"date":476,"type":42},"2026-02-23",{"date":478,"type":42},"2021-10-01",{"date":480,"type":20},"2030-03",{"name":482,"class":49},"Fundación Española de Hematología y Hemoterapía",51,{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":514,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":340},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":492,"type":20},98,[111],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[496,497,364,33,498,30,499,500,501,502,503,352,504,505,198,506,507,355,508,509,510,28,511,512,32,513],"Mature B-Cell Neoplasm","Non Hodgkin Lymphoma","MALT Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Burkitt Lymphoma","Plasmablastic Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","DLBCL Germinal Center B-Cell Type","Primary Mediastinal Large B Cell Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Duodenal-Type Follicular Lymphoma",[515,516,33],"MALT1","NF-kB","2026-02-11",{"date":519,"type":42},"2026-02-13",{"date":521,"type":42},"2023-04-10",{"date":523,"type":20},"2027-11",{"name":525,"class":133},"Schrödinger, Inc.",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":21,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":545,"locationsCount":547},"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":534,"type":20},60,[111],"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.",[538,33,30,353,198,31,539],"CLL\u002FSLL","Hairy Cell Leukemia","2026-02-10",{"date":519,"type":42},{"date":543,"type":42},"2021-07-19",{"date":395,"type":20},{"name":546,"class":133},"Newave Pharmaceutical Inc",4,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"100485537","phase-1-as-1763-in-patients-with-previously-treated-cllsll-or-non-hodgkin-lymphoma-100485537","NCT05602363","AS-1763 in Patients With Previously Treated CLL\u002FSLL or Non-Hodgkin Lymphoma","A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma or Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Provided written informed consent\n* Histologically confirmed B-cell malignancy, including CLL\u002FSLL, WM, MCL, MZL, or FL\n* Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion\n* Failed or are intolerant to ≥2 prior lines of systemic therapy\n* ECOG Performance Status 0 to 2\n* Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹\u002FL, platelet count ≥50 × 10⁹\u002FL, hemoglobin ≥8 g\u002FdL) not requiring transfusion support or growth factors\n* Adequate hepatic function\n* Adequate renal function\n* Ability to swallow tablets and comply with study requirements for the duration of study participation\n* Male and female patients of reproductive potential: Willing to observe conventional and effective birth control methods\n* Male patients: agree not to donate sperm during and for 6 months after the study\n* Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication\n\nExclusion Criteria:\n\n* Transformed disease (eg, Richter's transformation) prior to or during Screening\n* Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib\n* Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study\n* Requiring therapeutic anticoagulation with warfarin\n* Current treatment with certain strong CYP3A4 inhibitors or inducers\n* Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib\n* Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors\n* Refractory to transfusion support\n* Major surgery within 4 weeks before planned start of docirbrutinib\n* Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment\n* Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia\n* History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days\n* Active second malignancy unless in remission with life expectancy \\>2 years\n* Known central nervous system (CNS) involvement by systemic lymphoma\n* Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts\n* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) \\>470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF \\>470 msec on all 3 ECGs, during Screening\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Positive for HIV. For patients with unknown HIV status, HIV testing will be performed at Screening\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of docirbrutinib\n* Pregnant or lactating.\n* Known hypersensitivity to any component or excipient of docirbrutinib\n* Prior treatment with docirbrutinib\n* Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)\n* Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi",{"count":556,"type":20},120,[111],"This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL\u002FSLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.",[560,28,29,33,198,31,30,561],"B-cell Malignancy","Non-Hodgkin Lymphoma","2025-12-09",{"date":564,"type":42},"2025-12-10",{"date":566,"type":42},"2023-08-01",{"date":568,"type":20},"2027-09",{"name":570,"class":133},"Carna Biosciences, Inc.",13,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":21,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":594},"100558188","phase-2-study-evaluating-the-efficacy-and-tolerance-of-a-zanubrutinib-and-bgb-11417-combination-in-patients-previously-treated-for-waldenstrm-macroglobulinemia-100558188","NCT06547866","Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia","Open Label Phase 2 Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia. A FILO Study","WAZABI","Inclusion Criteria:\n\n1. Be ≥ 18-year-old.\n2. Have received at least 1 prior line of treatment (excluding treatment with any BTKi or Bcl-2 antagonist, see non-inclusion criteria).\n3. Provide written informed consent.\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.\n5. Have adequate renal function defined as creatinine clearance ≥ 50 mL\u002Fmin as determined by the Cockroft-Gault equation.\n6. Have adequate hepatic function defined as:\n\n   * total serum bilirubin ≤ 1.5 × ULN, unless bilirubin rise is due to Gilbert's syndrome or non-hepatic cause.\n   * alanine aminotransferase (ALAT) \\\u003C 2 × ULN\n   * aspartate aminotransferase (ASAT) \\\u003C 2 × ULN,\n7. Have adequate BM function defined as:\n\n   * absolute neutrophil count ≥ 1x109\u002FL\n   * platelet count ≥ 75 x109\u002FL\n8. For women of childbearing potential, a negative pregnancy test must be documented prior to enrollment.\n\n   * A woman is considered of childbearing potential, ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n   * A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.\n9. Agree to use a highly effective form of contraception with sexual partners throughout study participation (for female and male patients who are fertile). Patients using hormonal contraceptives (eg, birth control pills or devices) must use a barrier method of contraception (eg, condoms) as well.\n10. Ability to comply with study procedures, in the Investigator's opinion.\n11. Patient covered by any social security system\n\nExclusion Criteria:\n\n1. Have previously been treated with a BTK inhibitor.\n2. Have been previously treated with a bcl-2 antagonist.\n3. Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical signs of CNS disease, a lumbar puncture is not mandatory.\n4. Have significant or active cardiovascular disease:\n\n   * stage III to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure and\u002For with left ventricular ejection fraction \\\u003C 50%\n   * myocardial infarction within 6 months before study treatment.\n   * unstable angina within 6 months before study treatment.\n   * uncontrolled atrial arrhythmia.\n   * history of clinically significant ventricular arrhythmias (e.g sustained ventricular tachycardia, ventricular fibrillation, torsades de pointe).\n   * uncontrolled hypertension.\n   * history of stroke or intracranial hemorrhage within 180 days before the first dose of study drugs\n   * QTcF interval \\> 450 ms on screening electrocardiogram (ECG) evaluation.\n5. Have a history of stroke or intracranial hemorrhage within 6 months before first dose of study drug, have a history of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention:\n\n   * patients with constitutional hemophilia or von Willebrand's disease will be excluded.\n   * patients with acquired hemophilia will be excluded.\n   * Requires ongoing treatment with warfarin or warfarin derivatives.\n   * patients with acquired von Willebrand's disease related to WM can be included. i) if bleeding manifestations are considered as non-clinically significant (i.e.grade 2 or below) ii) or if bleeding manifestations have been corrected by plasma exchange\n6. Have received live vaccine within 4 weeks of inclusion.\n7. Receive other concomitant investigational therapy.\n8. Have a history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic condition that, in the opinion of the Investigator, would adversely affect a subject's participation in the study.\n9. Have currently active, clinically significant Child-Pugh Class B or C hepatic impairment.\n10. Present an inability or difficulty swallowing capsules\u002Ftablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function.\n11. Have a known allergy to either xanthine oxidase inhibitors or rasburicase or zanubrutinib (patients at risk for G6PD deficiency may be screened before enrolment).\n12. Are pregnant or lactating. Women of childbearing potential must agree to use highly effective contraception from the time of signing informed consent until end-of-treatment visit,\n\n    ≥90 days after last dose of BGB-11417-101 and Zanubrutinib. Male patients must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods.\n13. Have a history of other active malignancies requiring treatment within 3 years of study entry, with exception of (1) localized basal cell or squamous cell carcinoma of the skin, (2), adequately treated in situ endometrial carcinoma, (3) incidental histology finding of prostate carcinoma, (4) previous malignancy confined and treated locally (surgery or other modality) with curative intent.\n14. Be known to be positive for HIV.\n15. Present evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * uncontrolled and\u002For active systemic infection (viral, bacterial or fungal) including COVID-19\n    * chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[c\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients with serologic evidence of prior resolved infection can be included according to recommendations .\n16. Suffer from any condition or illness that, in the opinion of the Investigator or medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the study drugs.\n17. Have received or consumed any of the following within 3 days prior to the first dose of study drugs:\n\n    * grapefruit or grapefruit products.\n    * Seville oranges (including marmalade containing Seville oranges).\n    * star fruit.\n18. Have received a treatment with any of the following prior to the first dose of study drugs:\n\n    * ≤7 days steroid therapy with anti-neoplastic intent.\n    * ≤ 7 days or 5 half-lives (whichever is longer) of any moderate or strong CYP3A4 inhibitor and ≤ 14 days or 5 half-lives, (whichever is longer) of moderate or strong CYP3A4 inducer before the first dose of study drugs.\n    * allogeneic or autologous stem cell transplantation or CAR-T cell therapy less than 3 months before the first dose of study drugs.\n19. Severe or debilitating pulmonary disease.\n20. Major surgery within 4 weeks of the first dose of study drug.\n21. Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).\n22. Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.",{"count":581,"type":20},102,[61],"This is a French multicenter open label non-randomized Phase II trial evaluating the efficacy and tolerance of a combination of oral zanubrutinib and BGB-11417 in subjects aged 18 years and older with previously treated Waldenström macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the Second International Workshop on Waldenström's macroglobulinemia.\n\npopulation : Patients with previously treated Waldenstrom macroglobulinemia\n\nThe investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:\n\n* Cycle 1 with zanubrutinib only\n* Cycle 2 with zanubrutinib plus BGB-11417 ramp-up\n\n  * cycle 2, day 1 : 10mg\n  * cycle 2, day 2 : 20 mg\n  * cycle 2, day 3 : 40mg\n  * cycle 2, day 4-7 : 80md daily\n  * cycle 2, day 8 and beyond : 160 mg daily\n* Cycles 3-20 with zanubrutinib plus BGB-11417 full dose",[33],"2025-11-21",{"date":587,"type":42},"2025-11-26",{"date":589,"type":20},"2025-12-01",{"date":591,"type":20},"2031-12-31",{"name":593,"class":49},"French Innovative Leukemia Organisation",37,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":21,"phases":604,"briefSummary":605,"conditions":606,"keywords":608,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":615,"locationsCount":50},"100431090","prognostic-value-of-circulating-tumoral-dna-after-the-first-6-months-of-treatment-in-patients-with-waldenstrm-macroglobulinemia-100431090","NCT04893564","Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia","SLP-rares","Inclusion Criteria:\n\n* Patient with WM according to diagnostic criteria\n* Patients with WM followed in one of the centre of North-Western region.\n* Patients requiring first-line or subsequent-line therapy\n* Patients agreement for giving informed consent.\n* Social insurance system affiliation\n\nExclusion Criteria:\n\n* Patients with another chronic B-cell malignancy\n* patients with other lymphoplasmacytic proliferations\n* patients with marginal zone lymphoma.\n* Patients with WM and histologic transformation\n* Absence of informed consent",{"count":603,"type":20},90,[23],"Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK\u002FMAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics.\n\nThe purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression\u002Frelapse risk within the first 3 years after the first 6 months of treatment.",[607,33],"Waldenstrom's Disease",[607,33],"2025-09-02",{"date":611,"type":42},"2025-09-09",{"date":613,"type":42},"2022-05-16",{"date":243,"type":20},{"name":616,"class":49},"Centre Hospitalier Universitaire, Amiens",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":21,"phases":626,"briefSummary":627,"conditions":628,"keywords":629,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":50},"100542274","phase-1-autologouscd22-chimeric-antigen-receptor-cart-cells-in-wrecurrentrefractory-b-cell-lymphomas-100542274","NCT06340737","AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w\u002FRecurrent\u002FRefractory B Cell Lymphomas","Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas","Inclusion Criteria:\n\n* Disease: Must have histologically confirmed disease as defined by WHO 2016\\[117\\] of one of the following:\n\nFollicular Lymphoma, grade 1-3a\n\n1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.\n2. Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20 monoclonal antibody (unless CD20 negative) plus either Bendamustine, CHOP or CVP (R-Chemo). Must have completed 3 or more cycles of R-Chemo. Progression is measured from the initial day of treatment of the first cycle of R-Chemo. In the case of those who received anti-CD20 monoclonal antibody monotherapy previously and then received R-Chemo are also eligible if they are POD24, and progression is measured from the initial day of treatment of the first cycle of R-Chemo and not from the initial day of anti-CD20 monoclonal antibody monotherapy.\n\nMantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.\n\n2\\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.\n\nHairy cell leukemia (HCL)\n\n1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \\\u003C11 g\u002FdL), thrombocytopenia (platelets\\\u003C100 x 10\\^9 \u002FL), or neutropenia (absolute neutrophil count below 1.5 x 10\\^9\u002FL); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;\n2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.\n\nLymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed\n\n1\\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy\n\n1\\. Prior therapies must include a i. BTKi ii. either chemotherapy and\u002For proteasome inhibitor 3. Requires treatment based on the recommendations from the Second International Workshop on WM 4. Requires the presence of serum IgM that is at least 2 times the upper limit of normal 5. Patients cannot require plasmapheresis for symptomatic hyperviscosity. 6. Patients cannot have symptomatic central nervous system involvement (Bing-Neel syndrome) that would prevent the assessment of neurotoxicity 7. Patients cannot have transformed to large B cell lymphoma Burkitt lymphoma (BL)\n\n1\\. Relapsed or refractory to front line chemoimmunotherapy; Participants with high-grade B-cell lymphoma with MYC and BCL2 and\u002ForBCL6 rearrangements will be excluded.\n\nMarginal zone lymphoma (MZL)\n\n1\\. Must have received 2 prior lines of therapy including rituximab in combination with chemotherapy or a BTKi\n\nHistologically confirmed Large B-cell lymphoma (LBCL) by WHO 2008 including:\n\ni. DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR ii. primary mediastinal (thymic) large B cell lymphoma; OR iii. transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma to DLBCL; OR iv. Follicular Lymphoma Grade 3B\n\n• Subjects with DLBCL, Follicular Lymphoma Grade 3B -or-\n\nSubjects with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation:\n\n1\\) Must have received an anthracycline regimen and an anti CD20 monoclonal antibody (unless documented CD20-negative) and be refractory or relapsed after second line of LBCL treatment. Subjects with a partial response to second line therapy must be ineligible for autologous transplant.\n\n* Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:\n\n  1. Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL\n\n     Note: T cell\u002Fhistiocyte rich large B cell lymphoma is not eligible\n\n     The following criteria apply to all participants unless otherwise noted:\n\n  2\\. Measurable Disease:\n  1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\n     b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible\n  2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.\n  3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.\n\n  3\\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.\n\n  4\\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.\n\n  5\\. Meet required prior therapy washout windows prior to leukapheresis (see inclusion criteria for leukapheresis for details).\n\n  6\\. Participants with prior CAR therapy must be at least 30 days post CAR infusion and have \\\u003C 5% CD3+ cells express the previous CAR prior to apheresis, if a validated assay is available.\n\n  7\\. Toxicities from prior therapy stable or resolved (except for clinically non-significant toxicity and cytopenias covered in footnote).\n\n  8\\. Age ≥ 18 years of age. 9. Adequate performance status (ECOG 0, 1, or 2; or Karnofsky \\> 60%) 10. Adequate organ and marrow function as defined by:\n\n  \\- ANC ≥ 750\u002FuL\n  * Platelet count ≥ 50,000\u002FuL\n  * ALC ≥ 150\u002FuL\n  * Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \\\u003C 2 mg\u002FdL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL\u002Fmin, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg\u002Fdl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.\n  * No clinically significant pleural effusion or ascites\n  * Baseline oxygen saturation \\> 92% on room air ANC Platelet ALC Cr CreatCl AST\u002FALT Bilirubin LVEF O2 Sat\n  * 11\\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.\n\n    14\\. Must be able to provide informed consent (LAR is permitted if participant able to provide verbal assent).\n\nA participant will not be excluded because of pancytopenia ≥ Grade 3 if it is felt by the investigator to be due to underlying disease.\n\nExclusion Criteria:\n\n* Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n\n  2\\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety\n\n  3\\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.\n\n  4\\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and\u002For nucleic acid testing.\n\n  5\\. Active cerebrovascular ischemic\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.\n\n  6\\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.\n\n  7\\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.\n\n  8\\. Is pregnant or breastfeeding.\n\n  9\\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n\n  10\\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, or be likely to complete all protocol-required visits and procedures.",{"count":625,"type":20},148,[111],"This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed \u002F refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.",[30,198,539,32,502,31,33,354],[630,631,632,633,634,635],"lymphoma","leukemia","lymphodepleting chemotherapy","relapsed","refractory","systemic therapy","2025-08-04",{"date":638,"type":42},"2025-08-07",{"date":640,"type":42},"2024-03-29",{"date":642,"type":20},"2031-04",{"name":644,"class":49},"Stanford University",{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":21,"phases":653,"briefSummary":654,"conditions":655,"keywords":657,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":50},"100431481","clinical-study-of-the-hyperviscosity-syndrome-in-waldenstrm-macroglobulinemia-100431481","NCT04898647","Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia","SLPRaresHvisc","Inclusion Criteria:\n\n* Patient with WM\n* Patients that may require a first-line or subsequent-line therapy\n* patients who will require treatment initiation\n* patients with serum monoclonal component concentration greater than 15 g\u002FL and who will underwent hyperviscosity assessment, even if hyperviscosity is not found and in the absence of other treatment criteria, no treatment is finally initiated.\n* Patients agreeing to give informed consent.\n\nExclusion Criteria:\n\n* Patients with another chronic B-cell malignancy\n* patients with lymphoplasmacytic proliferations\n* patients with marginal zone lymphoma.\n* patients with WM and histologic transformation\n* Absence of informed consent.",{"count":451,"type":20},[23],"Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.\n\nThe present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.",[656,33],"Hyperviscosity Syndrome",[656,33],"2025-05-23",{"date":660,"type":42},"2025-05-29",{"date":662,"type":42},"2021-05-14",{"date":664,"type":20},"2026-08",{"name":616,"class":49},{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":674,"targetDuration":4,"studyType":21,"phases":676,"briefSummary":677,"conditions":678,"keywords":679,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":50},"100509533","phase-2-zanubrutinib-plus-br-in-newly-diagnosed-symptomatic-wm-100509533","NCT05914662","Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM","Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia","ZBR","Inclusion Criteria:\n\n* The gender of the patient is not limited, and the age is ≥18 years old;\n* Must meet WM's diagnostic standards;\n* The patient is an untreated or patient who has not undergone standard treatment.\n* The specific conditions are as follows:\n\n  1. No combined chemotherapy with BTKi, BR, RCD, VRD, CHOP and COP\n  2. No treatment regimen containing fludarabine\n  3. Chlorambucil or cyclophosphamide for less than 4 weeks (alone or in combination with adrenal glucocorticoids)\n  4. The above treatment did not reach the treatment response (MR)\n  5. If the above treatment has been applied, the treatment needs to be stopped for 2 weeks before entering the group to start treatment\n* The indications for the treatment of indolent lymphoma mainly include (at least one of the following conditions):\n\n  1. Symptomatic hyperviscosity;\n  2. Symptomatic peripheral neuropathy;\n  3. Amyloidosis;\n  4. Cold agglutinin disease; cryoglobulinemia;\n  5. Disease-related cytopenia (Hb\\\u003C100 g\u002FL, PLT\\\u003C100×10\\^9\u002FL);\n  6. Giant lymph nodes;\n  7. Those with systemic systemic symptoms: for two weeks\u002Frecurrent fever (above 38℃) and not caused by infection, or Night sweats and\u002For weight loss \\>10% within 6 months;\n  8. The disease progresses rapidly, for example, the lymph nodes increase by more than 50% within 2 months, and\u002For peripheral blood lymphocytes absolute value doubling time \\\u003C6 months, and\u002For rapid hemoglobin or platelet non-autoimmune causes slow down\n  9. When there is evidence that the disease has transformed.\n* ECOG score ≤ 2 points\n* Laboratory examination: neutrophils ≥ 0.75×10\\^9\u002FL; platelets ≥ 50×10\\^9\u002FL; total bilirubin ≤ 2.5 times upper limit; alanine aminotransferase\u002Faspartate aminotransferase ≤3 times upper limit. Creatinine clearance rate ≥ 30ml\u002Fmin.\n* The patient's expected survival time is ≥ 3 months.\n\nExclusion Criteria:\n\n* Malignant tumors (including active central nervous system lymphoma) other than B-NHL have been diagnosed or treated within the past year;\n* There is clinical evidence that large cell lymphoma transformation has occurred;\n* Non-lymphoma-related liver and kidney damage: alanine aminotransferase (ALT)\\> 3 times the upper limit of normal value, aspartate aminotransferase (AST)\\> 3 times the upper limit of normal value, total bilirubin (TBIL)\\> upper limit of normal value 2 Times, serum creatinine clearance rate \\\u003C30ml\u002Fmin;\n* Other serious medical conditions will affect the study (such as uncontrolled diabetes, gastric ulcers, other serious cardiopulmonary diseases, etc.). The decision-making power belongs to the researcher;\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n* Central nervous system dysfunction with clinical manifestations or central invasion (Bing-Neel syndrome);\n* Patients who have undergone major surgery (not including lymph node biopsy) within the past 14 days or expected major surgery during treatment;\n* Inability to swallow capsules or suffer from malabsorption syndrome, diseases that significantly affect gastrointestinal function, have undergone gastric or small bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, partial or complete intestinal obstruction.\n* Need to receive strong cytochrome P450 (CYP) 3A inhibitor treatment.\n* Women who are pregnant or breastfeeding, women of childbearing age who have not taken contraception;\n* Allergy to the drugs used.",{"count":675,"type":20},42,[61],"This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM",[33],[680,681,682],"Waldenstrom macroglobulinemia","Zanubrutinib","newly diagnosed","2024-08-26",{"date":685,"type":42},"2024-08-28",{"date":687,"type":42},"2023-02-15",{"date":689,"type":20},"2025-12-15",{"name":691,"class":49},"Institute of Hematology & Blood Diseases Hospital, China"]