Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
NCT03206918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91
Last updated 2024-10-26
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.
Conditions
- Relapsed or Refractory Chronic Lymphocytic Leukemia
- Relapsed or Refractory Small Lymphocytic Lymphoma
Interventions
- DRUG
-
Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID)
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Principal Investigators
-
Study Director · BeiGene
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-09
- Primary Completion
- 2018-06-15
- Completion
- 2020-09-10
Countries
- China
Study Locations
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