Glofitamab in Real Life

Not yet recruiting

• Conditions: Large B-cell Lymphoma
• Interventions: Drug: Glofitamab

• Registration Number: NCT06994169
• Lead Sponsor: The Lymphoma Academic Research Organisation

Brief Summary

To date, more than 300 patients have been treated with Glofitamab in the Expanded Access Programme (EAP) in France. In this study, it is proposed to perform a retrospective analysis of some of these patients. The aim is to describe the efficacy and safety of Glofitamab in the largest reported real-world cohort, with an expected median follow-up of more than 9 months. Particular focus will be given to the relapsed or refractory chimeric antigen receptors-T (CAR-T) population to confirm the response rates (CRR: 35-39%) of Glofitamab in this population and to assess the optimal timing of therapy initiation \[8, 15\].

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-08-01
• Primary Completion: 2025-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• patient enrolled in the French Glofitamab EAP for R/R DLBCL before 2024 November 1st, 2024
• patient who received at least Obinutuzumab pretreatment and one infusion of Glofitamab
• adult patient
• patient who is informed of the study and who did not oppose to their data collection

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated in EPA	Glofitamab	Patients treated in Expanded Access Program to Glofitamab

Primary Outcome Measures

Name	Time	Method
Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.	6 months

Secondary Outcome Measures

Name	Time	Method
Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria	1 month, 2 months, 3 months, 6 months
Progression-free survival (PFS)	6 months
Event-Free Survival (EFS)	6 months
Overall survival (OS)	6 months
immune effector cell-associated neurotoxicity syndrome (ICANS) rate	6 months
≥ grade 2 Cytokine release syndrome (CRS) rate	6 months
intensive care unit (ICU) admission rate	6 months
rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab,	6 months
number of significant medical events leading to hospitalization	6 months

Trial Locations

Locations (30)

CH Victor Dupouy; 🇫🇷 Argenteuil, France

CH d'Avignon - Hôpital Henri Dufaut; 🇫🇷 Avignon, France

CH de la Côte Basque; 🇫🇷 Bayonne, France

CHRU Besançon - Hôpital Minjoz; 🇫🇷 Besançon, France

Hopital D'Instruction Des Armees Percy; 🇫🇷 Clamart, France

Hopital Henri Mondor; 🇫🇷 Créteil, France

CHU de Dijon - Hôpital le Bocage; 🇫🇷 Dijon, France

CH de Dunkerque; 🇫🇷 Dunkerque, France

CHU de Grenoble - Hôpital Albert Michallon; 🇫🇷 La Tronche, France

Hôpital de Libourne; 🇫🇷 Libourne, France

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