At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 201 enrolled
Drug / intervention
BGB-3111 +1 moredrug
Likely dose
BGB-3111 160 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 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)
In Brief
A Phase 3 clinical trial evaluating BGB-3111 and Ibrutinib for Waldenström's Macroglobulinemia. Completed, enrolled 201 participants across 58 sites in 12 countries.
Detailed Summary
This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWaldenström's Macroglobulinemia
CountriesAustralia, Czechia, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJan 2017
First PostedFeb 2017
Primary CompletionJun 2022
TodayJul 2026
First PostedFeb 15, 2017
Enrollment StartJan 25, 2017
Primary CompletionJun 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.4 years ago
Interventions
BGB-3111drug
160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Ibrutinibdrug
420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor