Open Actively Recruiting

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

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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)