Trials / Active Not Recruiting
Active Not RecruitingNCT04002297
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 510 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | zanubrutinib | Administered as two 80 mg capsules by mouth twice a day |
| DRUG | bendamustine | Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6 |
| DRUG | rituximab | Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6 |
Timeline
- Start date
- 2019-08-20
- Primary completion
- 2027-03-01
- Completion
- 2027-12-01
- First posted
- 2019-06-28
- Last updated
- 2025-09-26
Locations
176 sites across 22 countries: United States, Australia, Austria, Belgium, Canada, China, France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Romania, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04002297. Inclusion in this directory is not an endorsement.