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

a study on Lymphoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

Summary

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R2) 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 R2 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.

Official Title

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

Keywords

Relapsed/Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Zanubrutinib, BGB-3111, Rituximab, Lenalidomide, Obinutuzumab, Lymphoma, Lymphoma, B-Cell, Marginal Zone

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • Ucsf Fresno University of California San Francisco Fresno accepting new patients
    Fresno California 93730 United States
  • UCLA Hematologyoncology accepting new patients
    Los Angeles California 90095 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • Sharp Healthcare Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States
  • Kaiser Permanente Southern California accepting new patients
    Irvine California 92618 United States
  • Scripps Health accepting new patients
    San Diego California 92103 United States
  • Los Angeles Cancer Network accepting new patients
    Los Angeles California 90017 United States
  • Cancer and Blood Specialty Clinic accepting new patients
    Los Alamitos California 90720 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT05100862
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 750 study participants
Last Updated