Status:
RECRUITING
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Lead Sponsor:
BeiGene
Conditions:
Relapsed/Refractory Follicular Lymphoma
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL),...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
- Key
Exclusion
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
- Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT05100862
Start Date
March 10 2022
End Date
June 1 2030
Last Update
February 23 2026
Active Locations (277)
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1
Ucsf Fresno University of California San Francisco Fresno
Fresno, California, United States, 93730-3595
2
Kaiser Permanente Southern California
Irvine, California, United States, 92618-3734
3
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720-3302
4
Los Angeles Cancer Network
Los Angeles, California, United States, 90017-4803