[{"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":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100464331","zanubrutinib-in-patients-with-waldenstrms-macroglobulinemia-chronic-lymphocytic-leukemia-marginal-zone-lymphoma-and-follicular-lymphoma-100464331",false,"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.","ALL","18 Years",{"count":20,"type":21},705,"ESTIMATED","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.",[25,26,27,28],"Waldenström's Macroglobulinemia","Chronic Lymphocytic Leukemia","Marginal Zone Lymphoma","Follicular Lymphoma",[25,30,31,26,27,28],"Zanubrutinib","Brukinsa","RECRUITING","2025-09-18",{"date":35,"type":36},"2025-09-23","ACTUAL",{"date":38,"type":36},"2022-04-26",{"date":40,"type":21},"2028-08",{"name":42,"class":43},"iOMEDICO AG","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"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":54,"type":21},54,"INTERVENTIONAL",[57],"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)",[25],"2023-10-04",{"date":62,"type":36},"2023-10-06",{"date":64,"type":36},"2019-03-06",{"date":66,"type":21},"2026-06-30",{"name":68,"class":69},"Kosin University Gospel Hospital","OTHER",1]