Trials / Completed
CompletedNCT04116437
Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
Conditions
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination. |
Timeline
- Start date
- 2019-10-15
- Primary completion
- 2026-01-09
- Completion
- 2026-01-09
- First posted
- 2019-10-04
- Last updated
- 2026-01-28
Locations
24 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04116437. Inclusion in this directory is not an endorsement.