Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
- Histologically confirmed diagnosis of MCL
- No prior systemic treatments for MCL
- Measurable disease by CT/MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Adequate marrow and organ function
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Known central nervous system involvement by lymphoma
- Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
- Clinically significant cardiovascular disease
- History of severe bleeding disorder
- Unable to swallow capsules or disease significantly affecting gastrointestinal function
- Active fungal, bacterial and/or viral infection requiring systemic therapy
- Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Age (in years)
60+
Phase
Phase 3
Participants needed
500
Est. Completion Date
Dec 31, 2027
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT04002297
Study number
BGB-3111-306
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