[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"waldenstrm-macroglobulinemia-wm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:waldenstrm-macroglobulinemia-wm":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,78,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100642551","phase-1-a-study-of-rocbrutinib-in-combination-with-lacutoclax-in-patients-with-b-cell-malignancies-100642551",false,"NCT07609862","A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex.\n2. Ib: Histologically confirmed diagnosis of CLL\u002FSLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.\n\n   II: For Treatment-naïve (TN) CLL\u002FSLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R\u002FR CLL\u002FSLL patients: at least one prior systemic therapy with documented disease progression or intolerance.\n3. Have at least one measurable lesion.\n4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.\n8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.\n2. Use of systemic corticosteroids at doses equivalent to \\>20 mg\u002Fday of prednisone for ≥3 days within 7 days prior to the first dose.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.\n9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Any severe and\u002For uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.\n11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.\n16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.\n17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.\n18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.\n19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.\n20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.","ALL","18 Years",{"count":19,"type":20},92,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib\u002FII clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.",[27,28,29,30,31],"Mantle Cell Lymphoma (MCL)","Diffuse Large B-Cell Lymphoma (DLBCL)","Follicular Lymphoma ( FL)","Waldenström Macroglobulinemia (WM)","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)",[33,34,35],"mature B-cell malignancies","BTK inhibitor","BCL-2 inhibitor","NOT_YET_RECRUITING","2026-06-07",{"date":39,"type":40},"2026-06-10","ACTUAL",{"date":42,"type":20},"2026-05-30",{"date":44,"type":20},"2033-05-30",{"name":46,"class":47},"Guangzhou Lupeng Pharmaceutical Company LTD.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100612155","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2003-in-patients-with-different-types-of-lymphoma-100612155","NCT07249905","Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma","A Phase 1\u002F2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma \\[HGBCL\\], primary mediastinal B-cell lymphoma \\[PMBCL\\], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.\n* Participant has relapsed or progressed on at least 2 prior lines of therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.\n* Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.\n* Adequate hematologic, hepatic and renal function.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Unresolved toxicities from previous anticancer therapy.\n* Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.\n* Active medical condition requiring chronic systemic steroid use (\\>10 mg\u002Fday prednisone or equivalent of \\>140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2003.\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.\n* Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.\n* Known hypersensitivity to allopurinol or rasburicase.\n* Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).\n* Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.",{"count":56,"type":20},180,[23,24],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma",[60,30,61,62,63,64,65,66],"Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","PMBCL","HGBCL","FL Lymphoma","Lymphoplasmacytic Lymphoma","Follicular Lymphoma (FL)","RECRUITING","2026-04-30",{"date":70,"type":40},"2026-05-04",{"date":72,"type":40},"2026-04-13",{"date":74,"type":20},"2030-04",{"name":76,"class":47},"ModeX Therapeutics, An OPKO Health Company",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":77},"100612864","phase-2-a-phase-ii-clinical-study-of-zanubrutinib-combined-with-four-cycles-of-cd20-monoclonal-antibody-and-reduced-dose-bendamustine-in-the-treatment-of-untreated-waldenstrm-macroglobulinemia-100612864","NCT07259122","A Phase II Clinical Study of Zanubrutinib Combined With Four Cycles of CD20 Monoclonal Antibody and Reduced-Dose Bendamustine in the Treatment of Untreated Waldenström Macroglobulinemia","ZBR in WM","Inclusion Criteria:\n\n* 1\\. Male or female patients aged ≥18 years.\n* 2\\. Must meet the diagnostic criteria for Waldenström's Macroglobulinemia (WM).\n* 3\\. Patients must be treatment-naïve or not have received standard prior therapy, as defined by the following conditions: a) No prior combined chemotherapy with regimens such as BR, RCD, BCD, CHOP, or COP. b) No prior therapy with fludarabine-containing regimens. c) Treatment with chlorambucil or cyclophosphamide (alone or in combination with glucocorticoids) for less than 4 weeks. d) Failure to achieve a minimal response (MR) from the above treatments. e) If any of the above treatments were previously administered, a washout period of at least 2 weeks must be completed before study treatment initiation.\n* 4\\. Presence of indications for WM treatment, meeting at least one of the following criteria: a) Symptomatic hyperviscosity. b) Symptomatic peripheral neuropathy. c) Amyloidosis. d) Cold agglutinin disease; cryoglobulinemia. e) Disease-related cytopenia (Hemoglobin \\\u003C100 g\u002FL or Platelet count \\\u003C100×10\\^9\u002FL). f) Massive lymphadenopathy. g) Presence of constitutional symptoms: persistent\u002Frecurrent fever (\\>38°C) for over 2 weeks unrelated to infection, drenching night sweats, and\u002For unintentional weight loss \\>10% within 6 months. h) Rapid disease progression, defined as a \\>50% increase in lymph node size within 2 months, and\u002For lymphocyte doubling time \\\u003C6 months, and\u002For rapid decline in hemoglobin or platelet counts not due to autoimmune causes. i) Evidence of histologic transformation.\n* 5\\. ECOG Performance Status score of ≤2.\n* 6\\. Laboratory values meeting the following criteria within the screening period: Absolute Neutrophil Count (ANC) ≥ 0.75 × 10\\^9\u002FL; Platelet count ≥ 50 × 10\\^9\u002FL; Total Bilirubin ≤ 2 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) \u002F Aspartate Aminotransferase (AST) ≤ 3 × ULN; Calculated creatinine clearance ≥ 30 mL\u002Fmin (using Cockcroft-Gault formula)\n* 7\\. Life expectancy of ≥ 6 months.\n\nExclusion Criteria:\n\n* 1\\. Diagnosis or treatment for any malignancy other than B-cell non-Hodgkin lymphoma (B-NHL) within the past year (including active central nervous system lymphoma).\n* 2\\. Clinical evidence of transformation to large cell lymphoma.\n* 3.Pre-existing severe hepatic or renal impairment unrelated to lymphoma: ALT \\> 3 × ULN; AST \\> 3 × ULN; Total Bilirubin \\> 2 × ULN; Estimated creatinine clearance \\\u003C 30 mL\u002Fmin\n* 4.Any other severe concurrent medical condition that would, in the investigator's judgment, compromise the patient's ability to participate in the study (e.g., uncontrolled diabetes, gastric ulcer, significant cardiac or pulmonary disease, etc.). The final determination rests with the investigator.\n* 5\\. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotic therapy. Note: Active HBV infection is defined by ALL of the following criteria: a. HBV DNA ≥ 2000 IU\u002FmL; b. ALT ≥ 2 × ULN; c. Hepatitis not attributable to other causes such as the underlying disease or drugs. Patients with initially active HBV who convert to an inactive carrier state after antiviral therapy may be enrolled if they receive adequate concomitant antiviral prophylaxis.\n* 6\\. Symptomatic central nervous system dysfunction or involvement (Bing-Neel syndrome).\n* 7\\. Major surgery within 14 days prior to the first dose of study drug or anticipated requirement for major surgery during the study treatment period (excluding lymph node biopsy).\n* 8\\. Inability to swallow capsules, or conditions significantly affecting gastrointestinal function (e.g., malabsorption syndrome, status post-gastrectomy or small bowel resection, symptomatic inflammatory bowel disease, ulcerative colitis, partial or complete intestinal obstruction).\n* 9\\. Requirement for concurrent strong Cytochrome P450 (CYP) 3A inhibitors.\n* 10\\. Pregnancy or lactation. Women of childbearing potential unwilling to use effective contraception during the study period.\n* 11\\. Known hypersensitivity to any of the study drugs or their excipients.\n\nWithdrawal Criteria\n\n* 1\\. Disease progression during treatment (after ≥2 cycles of therapy) or failure to achieve at least a minimal response (MR) after 6 cycles of therapy.\n* 2\\. Occurrence of intolerable adverse events or complications.\n* 3\\. Patient's voluntary decision to withdraw consent for continued treatment.\n* 4\\. Pregnancy during the study.\n* 5\\. Investigator's judgment that the patient should discontinue treatment for any other reason.","95 Years",{"count":87,"type":20},43,[24],"This study is a prospective phase II clinical trial designed to evaluate the deep response rate of the ZBR regimen (zanubrutinib combined with reduced-dose bendamustine and CD20 Monoclonal Antibody ) in treatment-naïve symptomatic Waldenström macroglobulinemia (WM) patients. Eligible patients will receive four cycles of the ZBR regimen, followed by zanubrutinib monotherapy for an additional eight months. The assessment period spans from the initiation of treatment until 12 months after treatment completion, with efficacy evaluations conducted every three cycles. Patients will be withdrawn from the study if they experience disease progression (PD) or show no response to treatment. Minimal residual disease (MRD) assessments will be performed at the end of the 3rd and 6th treatment cycles, as well as 12 months after treatment completion, involving evaluations of both bone marrow and peripheral blood MRD rates",[30],[92,93],"zanubrutinib","bendamustine","2025-11-21",{"date":96,"type":40},"2025-12-02",{"date":98,"type":20},"2025-12-30",{"date":100,"type":20},"2032-06-30",{"name":102,"class":103},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100605978","phase-1-ibrutinib-followed-by-br-bendamustine-and-rituximab-as-a-time-limited-therapy-for-waldenstrm-macroglobulinemia-100605978","NCT07169565","Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia","Phase I Clinical Study of Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia","Inclusion Criteria\n\n1. Patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).\n2. Patient of any gender, aged ≥18 years and ≤75 years.\n3. Patient must meet diagnostic criteria for Waldenström Macroglobulinemia (WM) and be MYD88 L265P mutation positive.\n4. Patient has documented baseline IgM levels and disease assessment parameters (including liver, spleen, lymph nodes; if extramedullary lesions exist, include assessment of other extramedullary sites) prior to ibrutinib use, to facilitate subsequent efficacy evaluation.\n5. ECOG performance status score of 0-1.\n6. Patient has received ≥12 cycles of ibrutinib monotherapy, achieved a treatment response (but not Complete Response (CR) ), and is currently on a treatment plateau.\n7. Patient has maintained good treatment tolerance (experienced no Grade ≥3 adverse reactions during ibrutinib therapy) and is still receiving ibrutinib.\n8. Patient has no prior treatment with Bendamustine combined with Rituximab (BR) regimen.\n9. Laboratory values:\n\n   * Neutrophils ≥1.0 × 10⁹\u002FL\n   * Platelets ≥50 × 10⁹\u002FL\n   * Hemoglobin ≥70 g\u002FL\n   * Total bilirubin ≤2 × Upper Limit of Normal (ULN)\n   * Alanine aminotransferase (ALT) \u002F Aspartate aminotransferase (AST) ≤3 × ULN\n   * Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula).\n10. Patient has an estimated life expectancy ≥6 months.\n\nExclusion Criteria\n\n1. Diagnosis or treatment for a malignancy other than B-cell Non-Hodgkin Lymphoma (B-NHL) within the past year (including active Central Nervous System lymphoma). Received other anti-tumor therapies (including chemotherapy, targeted therapy, hormonal therapy, anti-tumor Chinese herbs with activity) within 4 weeks prior to study drug administration (excluding ibrutinib) or participated in other clinical trials receiving investigational drugs.\n2. Clinical evidence of transformation to large cell lymphoma.\n3. Non-lymphoma related liver or kidney impairment:\n\n   * ALT \\>3 × ULN\n   * AST \\>3 × ULN\n   * Total bilirubin (TBIL) \\>2 × ULN\n   * Serum creatinine clearance \\\u003C30 mL\u002Fmin.\n4. Other severe medical conditions that could interfere with the study (e.g., uncontrolled diabetes, gastric ulcer, other severe cardiopulmonary diseases), as determined by the investigator.\n5. Cardiac function or disease meeting any of the following:\n\n   1. Long QTc syndrome or QTc interval \\>480 ms;\n   2. Complete left bundle branch block, second- or third-degree atrioventricular block;\n   3. Severe, uncontrolled arrhythmias requiring drug therapy;\n   4. New York Heart Association (NYHA) classification ≥ Class III;\n   5. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n   6. History within 6 months prior to enrollment: myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment; history of clinically significant pericardial disease; or ECG evidence of acute ischemia or active conduction system abnormalities.\n6. Known history of Human Immunodeficiency Virus (HIV) infection, or active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n\n   Note: Active HBV infection is defined as meeting ALL THREE criteria: a. HBV DNA quantification ≥2000 IU\u002FmL; b. ALT ≥2 × ULN; c. Hepatitis not attributable to other causes (e.g., disease itself, drugs). Patients initially diagnosed with active HBV infection who convert to inactive HBV status after anti-HBV therapy may be enrolled provided they receive adequate anti-HBV prophylaxis.\n7. Major surgery within 14 days prior to enrollment (excluding lymph node biopsy) or anticipated need for major surgery during the study.\n8. History or current diagnosis of another malignancy (except adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of the breast\u002Fcervix, and other malignancies effectively controlled without treatment for the past five years).\n9. Pregnant or lactating women, or women of childbearing potential not using contraception.\n10. Hypersensitivity to any of the study drugs or their components.\n11. Malabsorption syndrome, disease significantly affecting gastrointestinal function, gastrectomy, extensive small bowel resection potentially affecting absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restriction\u002Fbariatric surgery (e.g., gastric bypass).\n12. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.\n13. History of bleeding diathesis (e.g., hemophilia, von Willebrand disease).\n14. Requirement for or ongoing anticoagulation therapy with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days prior to the first dose of study drug.\n15. Diagnosis of gastrointestinal ulcer by endoscopy within 3 months prior to the first dose of study drug.","75 Years",{"count":113,"type":20},21,[23],"This is a two-part, non-randomized, open-label Phase I clinical study. The research consists of:\n\n1. A 3+3 dose-escalation phase to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of the I+BR regimen in Waldenström Macroglobulinemia (WM) patients;\n2. A dose-expansion phase to evaluate the safety, tolerability, and efficacy of the time-limited regimen at the MTD\u002FRP2D.\n\nKey Study Design Details:\n\nPre-enrollment \\& Eligibility:\n\n* Patients undergo efficacy and tolerability assessment before enrollment.\n* Eligible patients receive I+BR therapy.\n\nTreatment Regimen:\n\n* Bendamustine: Tested at three dose levels (70 mg\u002Fm², 60 mg\u002Fm², and 50 mg\u002Fm²) based on prior IBR data in B-cell lymphomas. A 3+3 dose de-escalation design is employed.\n* Fixed Doses:\n\n  * Ibrutinib: 420 mg\u002Fday\n  * Rituximab: 375 mg\u002Fm²\n\nPart I (3+3 Dose Escalation):\n\n* Start with 3 patients receiving bendamustine 70 mg\u002Fm².\n* After 1 treatment cycle:\n\n  * Assess Dose-Limiting Toxicity (DLT) (DLT criteria defined separately).\n  * Patients without DLT proceed to 2 additional cycles of IBR.\n* After 3 total cycles:\n\n  * Efficacy assessment is performed.\n  * Patients achieving minimal response (MR) or better (i.e., MR, PR, VGPR, CR) receive 1 cycle of BR, then cease treatment and enter follow-up.\n  * Patients failing to achieve ≥MR are withdrawn.\n* Primary Objective: Evaluate safety and identify MTD.\n\nPart II (Dose Expansion):\n\n* Enroll 15 additional patients at MTD\u002FRP2D.\n* Objectives:\n\n  * Further assess safety and efficacy;\n  * Monitor IgM rebound within 2 months after completing therapy (3 cycles I+BR → 1 cycle BR);\n  * Explore correlations between biomarkers and clinical outcomes.\n\nTerminology Notes:\n\n* I+BR: Ibrutinib + Bendamustine\u002FRituximab\n* DLT: Dose-Limiting Toxicity\n* MTD: Maximum Tolerated Dose\n* RP2D: Recommended Phase II Dose\n* Efficacy thresholds: MR (Minimal Response), PR (Partial Response), VGPR (Very Good Partial Response), CR (Complete Response)\n* Time-limited therapy: Fixed-duration treatment designed to avoid indefinite dosing.",[30],[118,119,120],"Waldenström Macroglobulinemia","ibrutinib","fixed dose","2025-09-05",{"date":123,"type":40},"2025-09-11",{"date":125,"type":20},"2025-09-01",{"date":127,"type":20},"2028-09-01",{"name":102,"class":103}]