Trials / Completed
CompletedNCT03332017
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
Detailed description
This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Oral administration as a capsule |
| DRUG | Obinutuzumab | Intravenous administration |
Timeline
- Start date
- 2017-11-14
- Primary completion
- 2021-10-08
- Completion
- 2024-12-27
- First posted
- 2017-11-06
- Last updated
- 2026-02-18
- Results posted
- 2024-04-30
Locations
88 sites across 17 countries: United States, Australia, Belarus, Bulgaria, Canada, China, Czechia, France, Germany, Italy, New Zealand, Poland, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03332017. Inclusion in this directory is not an endorsement.