Clinical Trial

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

Study acronym: ZBR in WM
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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 Patients will be withdrawn from the study if they experience disease progression (PD) or show no response to treatment.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
Trial Details
NCT Number NCT07259122
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Waldenström Macroglobulinemia (WM)
Enrollment 43 participants
Start Date 2025-12-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2032-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-02