A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants 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.

Conditions

Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Relapsed/Refractory Follicular Lymphoma
Intervention / Treatment

-

Contacts and Locations

Fresno

Ucsf Fresno University of California San Francisco Fresno, Fresno, California, United States, 93730

Irvine

Kaiser Permanente Southern California, Irvine, California, United States, 92618

Los Alamitos

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States, 90720

Los Angeles

Los Angeles Cancer Network, Los Angeles, California, United States, 90017

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Los Angeles

UCLA Hematologyoncology, Los Angeles, California, United States, 90095

San Diego

Scripps Health, San Diego, California, United States, 92103

San Diego

Sharp Healthcare Sharp Memorial Hospital, San Diego, California, United States, 92123

Jacksonville

Baptist Md Anderson Cancer Center, Jacksonville, Florida, United States, 32207

Pembroke Pines

Memorial Cancer Institute, Memorial Healthcare System, Pembroke Pines, Florida, United States, 33026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Director, PRINCIPAL_INVESTIGATOR, BeiGene

Study Record Dates

2030-06