NCT06624085

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Glofitamab	Participants will receive IV glofitamab for up to 12 cycles (cycle length = 21 days)
DRUG	Tocilizumab	Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS)
DRUG	Obinutuzumab	Participants will receive IV obinutuzumab pretreatment
DRUG	Gemcitabine	Participants will receive IV gemcitabine for up to 8 cycles (cycle length = 21 days)
DRUG	Oxaliplatin	Participants will receive IV oxaliplatin for up to 8 cycles (cycle length = 21 days)

Timeline

• Start date: 2025-04-28
• Primary completion: 2030-03-31
• Completion: 2030-03-31
• First posted: 2024-10-02
• Last updated: 2026-04-02

Locations

16 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study