Trials / Completed
CompletedNCT03206918
Efficacy and Safety of Zanubrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID) |
Timeline
- Start date
- 2017-03-09
- Primary completion
- 2018-06-15
- Completion
- 2020-09-10
- First posted
- 2017-07-02
- Last updated
- 2024-10-26
- Results posted
- 2020-09-25
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03206918. Inclusion in this directory is not an endorsement.