drugset / Trial / NCT06806033

A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

NCT06806033

Phase 2 Recruiting 100 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.

Timeline

Start
2025-03-05
Primary completion
2027-01-31
Completion
2029-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule Intravenous
Subject Glofitamab Monoclonal antibody Intravenous
Subject Obinutuzumab Monoclonal antibody Intravenous
Subject Oxaliplatin Small molecule Intravenous