drugset / Trial / NCT07169331

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

NCT07169331

Phase 4 Recruiting 18 enrolled BeiGene
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-17
Primary completion
2028-10-31
Completion
2028-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Zanubrutinib Small molecule 160 mg Oral