drugset / Trial / NCT04408638

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638

Phase 3 Active not recruiting 270 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Timeline

Start
2021-02-23
Primary completion
2028-03-31
Completion
2028-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Glofitamab Monoclonal antibody 30 mg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Obinutuzumab Monoclonal antibody Intravenous
Background Oxaliplatin Small molecule 100 mg/m2 Intravenous
Background Tocilizumab Monoclonal antibody Intravenous