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Clinical Trial Summary

This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy of zanubrutinib combined with BR (Bendamustine/Rituximab) regimen in Chinese participants with newly-diagnosed Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the 11th International Workshop on Waldenström's Macroglobulinemia (IWWM). The investigators propose this combination will improve the deep remission compared to single Zanubrutinib or BR regimen and can be a time-limited regimen which will reduce the life-time therapy and benefit the patients.


Clinical Trial Description

The study comprised an initial screening phase (up to 7 days), a single-arm treatment phase, and a follow-up phase. Subjects with newly-diagnosed Waldenström's macroglobulinemia can participate if all eligibility criteria are met. The participants will receive bendamustine and rituximab for 6 28-day cycles. Bendamustine will be given intravenously at 70-90 mg/m2 on days 1 and 2 of each cycle. Rituximab will be given on day 1 of each cycle (375 mg/m2 intravenously), Zanubrutinib will be given orally 160mg Bid per day, up to 12 months. The participants with WM will also have disease assessment with Lymph node ultrasound and abdominal ultrasound each cource, serum IgM, serum protein electrophoresis (SPE), immunofixation (IFA), and viscosity assessments will be measured serially. A bone marrow aspiration and biopsy flow cytometry examination will be done before treatment and at response assessment at cycle 6 and 12. Durability of response will also be assessed every 3 months after treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05979948
Study type Interventional
Source Shanghai Changzheng Hospital
Contact Haiyan He, Master
Phone +8613661513012
Email doctorhehaiyan@126.com
Status Recruiting
Phase Phase 2
Start date August 1, 2023
Completion date December 1, 2025

See also
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Recruiting NCT03697356 - R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia Phase 2
Completed NCT02165397 - Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia Phase 3
Completed NCT03053440 - A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) Phase 3
Recruiting NCT05326308 - Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma