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Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

Study acronym: ZBR
StatusUnknown
PhasePhase 2
Started2023-02-15
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 28, 2024 (before its estimated March 15, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2024-08-26
minor
Study Identification, Study Status, Study Design, Outcome Measures v1
Trial statusRecruiting→Unknown
Enrollment target30→42
Secondary endpointsdetails revised at 1 of 7 entries
2023-06-13
minor
Original filing
This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM
Trial Details
NCT Number NCT05914662
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Waldenstrom Macroglobulinemia
Enrollment 42 participants
Start Date 2023-02-15
Primary Completion 2025-03-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2024-08-28