Trials / Completed
CompletedNCT03520920
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
A Phase 2 Study to Assess the Safety, Tolerability, and Activity of BGB-3111 in Combination With Rituximab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Non-GCB Subtype) and Relapsed/Refractory Indolent Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (non-GCB \[non-germinal center B-cell-like\] subtype) and R/R indolent lymphoma (follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Administered zanubrutinib 160 mg orally (PO) BID continuously |
| DRUG | Rituximab | Administered rituximab 375 mg/m\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long. |
Timeline
- Start date
- 2018-01-04
- Primary completion
- 2020-08-28
- Completion
- 2020-08-28
- First posted
- 2018-05-11
- Last updated
- 2024-10-26
- Results posted
- 2021-10-28
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03520920. Inclusion in this directory is not an endorsement.