Trials / Recruiting
RecruitingNCT07169331
A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia
A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Administered orally |
Timeline
- Start date
- 2025-10-17
- Primary completion
- 2028-10-31
- Completion
- 2028-10-31
- First posted
- 2025-09-11
- Last updated
- 2025-12-19
Locations
8 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07169331. Inclusion in this directory is not an endorsement.