At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
Zanubrutinibdrug
Likely dose
Zanubrutinib 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Zanubrutinib for Waldenström's Macroglobulinemia (WM). Completed, enrolled 44 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenström's Macroglobulinemia (WM)
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedNov 2017
Primary CompletionMay 2019
Study CompletionJan 2021
TodayJul 2026
First PostedNov 6, 2017
Enrollment StartAug 31, 2017
Primary CompletionMay 8, 2019
Study CompletionJan 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.7 years ago
Interventions
Zanubrutinibdrug
Oral administration using 80 mg capsules