NCT03332173

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.

Conditions

• Waldenström's Macroglobulinemia (WM)

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Oral administration using 80 mg capsules

Timeline

• Start date: 2017-08-31
• Primary completion: 2019-05-08
• Completion: 2021-01-11
• First posted: 2017-11-06
• Last updated: 2024-10-26
• Results posted: 2022-03-08

Locations

10 sites across 1 country: China