OncRef

Clinical 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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2026-10-02

Study Overview

Brief 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.

Official Title

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Conditions

Diffuse Large B-cell Lymphoma

Intervention / Treatment

  • Drug: Obinutuzumab
  • Drug: Glofitamab
  • Drug: Rituxumab
  • Drug: Tocilizumab
  • Drug: Gemcitabine
  • Drug: Oxaliplatin

Other Study ID Numbers

  • GO41944
  • 2020-001021-31

Start Date (Actual)

2021-02-23

Primary Completion Date (Estimated)

2028-03-31

Study Completion Date (Estimated)

2028-03-31

Enrollment (Estimated)

270

Study Type

Interventional

Phase

Phase 3