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Recruiting NCT05100862

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Conditions: Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 780
Sponsor: BeOne Medicines

Location: Ucsf Fresno University of California San Francisco Fresno Fresno California

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), 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.

Eligibility 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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05100862). StuddyBuddy aggregates publicly available trial information.