A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
About the study
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), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Key Exclusion Criteria:
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Relapsed/Refractory Follicular Lymphoma,Marginal Zone Lymphoma
Age
18+
Phase
PHASE3
Participants Needed
750
Est. Completion Date
Jun 30, 2030
Treatment Type
INTERVENTIONAL
Sponsor
BeiGene
ClinicalTrials.gov NCT Identifier
NCT05100862
Study Number
BGB-3111-308
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