Not currently recruiting at UCSF

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 Fresno 5350937, California 5332921 and other locations
Dates
study started
study ends 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, Follicular 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 UCSF Fresno in progress, not accepting new patients
    Fresno 5350937 California 5332921 93730-3595 United States
  • Valkyrie Clinical Trials in progress, not accepting new patients
    Los Angeles 5368361 California 5332921 90067-2011 United States
  • Matsuyama Red Cross Hospital accepting new patients
    Matsuyama 1926099 Ehime 1864226 790 8524 Japan
  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital accepting new patients
    Hiroshima 1862415 Hiroshima 1862413 730-8619 Japan
  • National Hospital Organization Hokkaido Cancer Center accepting new patients
    Sapporo 2128295 Hokkaido 2130037 003-0804 Japan
  • Aiiku Hospital accepting new patients
    Sapporo 2128295 Hokkaido 2130037 064-0804 Japan
  • Kagoshima University Hospital not yet accepting patients
    Kagoshima 1860827 Kagoshima-ken 1860825 890-8520 Japan
  • Kanagawa Cancer Center accepting new patients
    Yokohama 1848354 Kanagawa 1860291 241-8515 Japan
  • University Hospital, Kyoto Prefectural Univ of Medicine accepting new patients
    KyotoShi Kyoto 1857907 602-8566 Japan
  • Tohoku University Hospital not yet accepting patients
    Sendai 2111149 Miyagi 2111888 980-8574 Japan

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT05100862
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 780 study participants
Last Updated