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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)


Outcome Timeframe Approximately 78 months

NCTID NCT05100862

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2022-03-10

Completion Date 2028-07

Enrollment Target 750

Interventions

DRUG Zanubrutinib

DRUG Rituximab

DRUG Lenalidomide

DRUG Obinutuzumab

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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