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A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglobulinemia

StatusActive, Not Recruiting
PhasePhase 4
SponsorBeiGene
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 11% 18 → 16 participants
See other at-risk trials from BeiGene

Record History

  1. Minor Enrollment closed, study ongoing Enrollment reduced: 18 → 16 participants · Study sites: 8 to 6v4 Show 2 more changesShow less
    • Enrollment reduced: 18 → 16 participants
    • Study sites: 8 to 6
  2. Minor Study sites: 7 to 8v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Oct 15, 2025 to Oct 17, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Oct 15, 2025 to Oct 17, 2025
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
37 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07169331
Lead Sponsor BeiGene
Conditions Waldenström's Macroglobulinemia
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov