At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Zanubrutinibdrug
Likely dose
Zanubrutinib 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 Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
In Brief
A Phase 2 clinical trial evaluating Zanubrutinib for Relapsed or Refractory Chronic Lymphocytic Leukemia and Relapsed or Refractory Small Lymphocytic Lymphoma. Completed, enrolled 91 participants across 11 sites.
Detailed Summary
This was a single-arm, open-label, multi-center Phase 2 study in participants with histologically documented CLL/SLL who have relapsed after or refractory to ≥ 1 prior treatment regimen(s). The study is composed of an initial screening phase, a single-arm treatment phase, and a follow-up phase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
CountriesChina
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedJul 2017
Primary CompletionJun 2018
Study CompletionSep 2020
TodayJul 2026
First PostedJul 2, 2017
Enrollment StartMar 9, 2017
Primary CompletionJun 15, 2018
Study CompletionSep 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9 years ago
Interventions
Zanubrutinibdrug
Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID)