A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
NCT07169331 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-12-19
Summary
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.
Conditions
- Waldenström's Macroglobulinemia
Interventions
- DRUG
-
Administered orally
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
Study Director · BeiGene
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-17
- Primary Completion
- 2028-10-31
- Completion
- 2028-10-31
Countries
- China
Study Locations
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