drugset / Trial / NCT05100862

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

NCT05100862

Phase 3 Active not recruiting 799 enrolled BeOne Medicines
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-10
Primary completion
2028-07
Completion
2030-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lenalidomide Other / unclassified 10 mg Oral
Comparator Lenalidomide Other / unclassified 20 mg Oral
Subject Obinutuzumab Monoclonal antibody 1000 mg
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zanubrutinib Small molecule 160 mg Oral
Subject Zanubrutinib Small molecule 320 mg Oral