A Study of Zanubrutinib Versus Lenalidomide in Participants With Relapsed/Refractory Marginal Zone Lymphoma

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the efficacy of zanubrutinib plus rituximab versus lenalidomide plus rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL), 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Lenalidomide; Rituximab; Zanubrutinib

Criteria

Key Inclusion Criteria:

1. Histologically confirmed CD20-positive MZL.

2. Previously received ≥ 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.

3. Need for systemic therapy for MZL.

4. Measurable disease by computed tomography or magnetic resonance imaging.

5. Adequate bone marrow, liver and renal function

Key Exclusion Criteria:

1. Transformation to aggressive lymphoma.

2. Requiring ongoing need for corticosteroid treatment.

3. Clinically significant cardiovascular disease.

4. Prior malignancy within the past 2 years.

5. Active fungal, bacterial, and/or viral infection that requires systemic therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.