drugset / Trial / NCT06084936

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

NCT06084936

Phase 3 Recruiting 182 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Timeline

Start
2023-10-22
Primary completion
2027-08-31
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule Intravenous
Subject Glofitamab Monoclonal antibody Intravenous
Comparator Lenalidomide Other / unclassified Oral
Comparator Rituximab Monoclonal antibody Intravenous
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous
Background Tocilizumab Monoclonal antibody Intravenous

Indications