Phase II Study of Glofitamab with Gemcitabine and Oxaliplatin to Improve Cytokine Release Syndrome in Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are studying an optimized treatment approach for participants with relapsed or refractory aggressive B-cell Non-Hodgkins lymphoma. This Phase II trial focuses on improving the cytokine release syndrome CRS profile when using glofitamab combined with gemcitabine and oxaliplatin. The study aims to enable this treatment to be given safely in an outpatient setting through a special steroid premedication regimen and monitoring schedule. Participants receive intravenous obinutuzumab as a pre-treatment seven days before starting the main therapy. Then, they receive a combination of intravenous glofitamab, gemcitabine, and oxaliplatin for up to eight 21-day cycles, followed by glofitamab alone for up to twelve 21-day cycles. The treatment is given in a single group without placebo or comparison arms. During the study, participants are closely monitored for cytokine release syndrome and other responses to treatment. The main outcome measured is the incidence of CRS up to approximately five years. Researchers also assess response rates, duration of response, progression-free survival, and overall survival. Safety and effectiveness are tracked through regular assessments and follow-up visits throughout the study period.

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