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A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Description
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.
Trial Eligibility
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 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 * 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.
Study Info
Organization
BeiGene
Primary Outcome
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Interventions
Locations Recruiting
Los Angeles Cancer Network
United States, California, Los Angeles
Valkyrie Clinical Trials
United States, California, Los Angeles
Baptist Md Anderson Cancer Center
United States, Florida, Jacksonville
Northwest Georgia Oncology Centers Marietta
United States, Georgia, Marietta
Fort Wayne Medical Oncology and Hematology
United States, Indiana, Fort Wayne
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