Glofitamab in Real Life for Large B-cell Lymphoma Treating Patients in Expanded Access Program

What this Trial Is About

Researchers are analyzing the real-world experience of patients treated with Glofitamab for relapsed or refractory large B-cell lymphoma DLBCL. This observational study focuses on patients who participated in the French Expanded Access Programme EAP, with more than 300 treated patients and a median follow-up expected to exceed nine months. The study particularly aims to confirm the response rates of Glofitamab in patients who have previously received CAR-T therapy and to determine the best timing to start the treatment. The study includes patients who received at least one infusion of Glofitamab following pretreatment with Obinutuzumab as part of the Early Phase Access program. The treatment details are collected retrospectively from patients enrolled before November 1, 2024. The primary outcome being assessed is the best complete response rate during treatment, based on investigator evaluation using Lugano 2014 criteria at six months. Participants data will be reviewed to measure treatment effectiveness and safety, including complete metabolic response rates, progression-free survival, event-free survival, overall survival, rates of immune-related side effects like neurotoxicity and cytokine release syndrome, ICU admissions, and hospitalization events over six months. This analysis helps to better understand Glofitamabs performance in a large real-world patient group, with continued monitoring of outcomes and adverse events during the follow-up period.

Glofitamab in Real Life