[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"waldenstrms-macroglobulinemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:waldenstrms-macroglobulinemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,69],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100605960","phase-4-a-study-to-evaluate-the-efficacy-and-safety-of-zanubrutinib-in-chinese-adults-with-treatment-naive-waldenstrm-macroglobulinemia-100605960",false,"NCT07169331","A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia","A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia","Inclusion Criteria:\n\n* Clinical and definitive histologic diagnosis of WM. Participant must be treatment-naive.\n* Participant must meet at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's macroglobulinemia (IWWM).\n* Participant must have measurable disease, as defined by serum immunoglobulin M (IgM) level \\> 0.5 g\u002FdL.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Participants must have adequate organ function as indicated by the following laboratory values ≤ 7 days before the first dose of study treatment:\n\n  1. Participants must not have required blood transfusion or growth factor support ≤ 7 days before sample collection at screening for the following:\n\n     * Absolute neutrophil count (ANC) ≥ 0.75 x 10\\^9\u002FL.\n     * Platelets ≥ 50 x 10\\^9\u002FL.\n  2. Creatinine clearance of ≥ 30 ml\u002Fmin as estimated by the Cockcroft-Gault formula.\n  3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).\n  4. Serum total bilirubin ≤ 2 x ULN (total bilirubin must be \\\u003C 3 x ULN for participants with Gilbert syndrome).\n* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for at least 1 month after the last dose of zanubrutinib. They must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study treatment.\n\nExclusion Criteria:\n\n* Evidence of disease transformation at the time of study entry.\n* Central nervous system (CNS) involvement by WM. Patients with a history of CNS involvement must undergo magnetic resonance imaging (MRI) and cerebrospinal fluid cytology studies to document no evidence of CNS disease prior to study entry.\n* Evidence of disease transformation at the time of study entry.\n* Participants with any of the following cardiovascular risk factors:\n\n  1. Active cardiac ischemia (eg, cardiac chest pain) ≤ 28 days before first dose of study drug.\n  2. Any history of acute myocardial infarction ≤ 6 months before the first dose of study drug.\n  3. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 7)≤ 6 months before the first dose of study drug.\n  4. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before the first dose of study drug.\n  5. Active, clinically significant second-degree atrioventricular block Mobitz II, or third degree atrioventricular block.\n  6. Any history of cerebrovascular accident ≤ 6 months before the first dose of study drug.\n  7. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug.\n  8. Any episode of syncope or seizure ≤ 28 days before first dose of study drug.\n* At the time of study entry, participants taking warfarin or other vitamin K antagonists.\n* Participants requiring ongoing therapy with strong or moderate cytochrome CYP3A inducers\n* Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy, targeted therapy, or radiation therapy within 4 weeks, or antibody-based therapy within 4 weeks before the start of study drug.\n* Major surgical procedure within 4 weeks before the start of study treatment (bone marrow aspirate and biopsy procedures are not considered major surgical procedures).\n\nNote: Other protocol defined criteria may apply","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The purpose of this study is to measure the efficacy and safety with zanubrutinib in adults with Treatment-Naive (TN) Waldenström Macroglobulinemia (WM). The main objective of this Phase 4 study is to further characterize the efficacy of zanubrutinib in Chinese participants with TN WM in order to fulfill the post-marketing requirements from the National Medical Products Administration (NMPA). Safety data will be collected and evaluated in this study as well.",[26],"Waldenström's Macroglobulinemia","RECRUITING","2025-12-15",{"date":30,"type":31},"2025-12-19","ACTUAL",{"date":33,"type":31},"2025-10-17",{"date":35,"type":20},"2028-10-31",{"name":37,"class":38},"BeiGene","INDUSTRY",8,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100464331","zanubrutinib-in-patients-with-waldenstrms-macroglobulinemia-chronic-lymphocytic-leukemia-marginal-zone-lymphoma-and-follicular-lymphoma-100464331","NCT05326308","Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma","Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study","ARIADNE","Inclusion Criteria:\n\n* Waldenström's macroglobulinemia (all treatment lines) OR\n* Chronic lymphocytic leukemia (all treatment lines) OR\n* Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy)\n* Follicular lymphoma (≥3 treatment line)\n* Signed and dated informed consent form\n* Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL\n* Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC\n* Treatment decision before inclusion into this non-interventional study\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Contraindications according to SmPC for patients with WM, CLL, MZL or FL\n* Participation in an interventional clinical trial during zanubrutinib treatment.",{"count":49,"type":20},705,"OBSERVATIONAL","The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.",[26,53,54,55],"Chronic Lymphocytic Leukemia","Marginal Zone Lymphoma","Follicular Lymphoma",[26,57,58,53,54,55],"Zanubrutinib","Brukinsa","2025-09-18",{"date":61,"type":31},"2025-09-23",{"date":63,"type":31},"2022-04-26",{"date":65,"type":20},"2028-08",{"name":67,"class":38},"iOMEDICO AG",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100339273","phase-2-r-vrd-followed-by-lenalidomide-maintenance-in-patients-with-waldenstroms-macroglobulinemia-100339273","NCT03697356","R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia","A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia","Ballondor","Inclusion Criteria:\n\n1. Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia\n2. Patients who meet criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's macroglobulinemia\n3. Male or female patients aged ≥19 years\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n5. Patients must have measurable disease, IgM \\> 0.5g\u002FdL\n6. Appropriate bone marrow, liver, and kidney function\n7. Patients who are able to understand oral and written instructions and who are able to comply with all requirements\n8. Patients who provided agreement of subject consent (ICF) prior to initiation of clinical trial.\n9. Female patients had to be post-menopausal for ≥1 year, surgically sterile, or practicing an effective method of birth control (as described in the protocol), and have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening; they also had to agree to continue using birth control measures for ≥6 months after terminating treatment. Male patients had to agree to use an acceptable method of contraception for the duration of the study.\n\nExclusion Criteria:\n\n1. Central nervous system involvement central nervous system (CNS) involvement by Waldenström's macroglobulinemia\n2. Patients who have received rituximab, lenalidomide, or bortezomib\n3. Patients who are allergic or hypersensitive to mouse (murine), chimeric, human or humanized proteins, lenalidomide, bortezomib\n4. One of the following labs or more:\n\n   * Absolute neutrophil count (ANC) \\\u003C1,000 \u002F μL\n   * Platelet count \\\u003C75,000 cells \u002F μL when not transfused\n   * Serum AST \u002F ALT\\> 3 times the upper limit of normal\n5. Renal failure requiring hemodialysis or peritoneal dialysis\n6. Patients with uncontrolled severe heart disease\n7. Patients who can not or do not want antithrombotic therapy\n8. Patient has more than Grade 2 peripheral neuropathy on clinical examination during the screening period\n9. Patient with a history of stroke or cerebral hemorrhage within 12 months bofore signing ICF\n10. Patients who have been diagnosed with a currently unadjusted severe infection\n11. Patients with known human immunodeficiency virus (HIV), hepatitis C infection\n12. Patients diagnosed with malignancy within 5 years before signing ICF\n13. Pregnant or lactating patients\n14. Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor\n15. Patients with acute diffuse invasive pulmonary disease and cardiovascular disease","19 Years",{"count":79,"type":20},54,[81],"PHASE2","A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)",[26],"2023-10-04",{"date":86,"type":31},"2023-10-06",{"date":88,"type":31},"2019-03-06",{"date":90,"type":20},"2026-06-30",{"name":92,"class":93},"Kosin University Gospel Hospital","OTHER",1]