Glofitamab in Real Life
1 other identifier
observational
250
1 country
30
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 \[8, 15\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedJanuary 14, 2026
January 1, 2026
4 months
May 20, 2025
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.
6 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
Patients treated in EPA
Patients treated in Expanded Access Program to Glofitamab
Interventions
Eligibility Criteria
French patients enrolled in the EAP before 1st of November 2024 and treated with at least Obinutuzumab pretreatment and one infusion of Glofitamab for R/R DLBCL We expect to collect data from 200-250 patients from this population with a minimum of 6 months of follow-up.
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
CH Victor Dupouy
Argenteuil, 95100, France
CH d'Avignon - Hôpital Henri Dufaut
Avignon, 84000, France
CH de la Côte Basque
Bayonne, France
CHRU Besançon - Hôpital Minjoz
Besançon, France
Hopital D'Instruction Des Armees Percy
Clamart, 92141, France
Hopital Henri Mondor
Créteil, France
CHU de Dijon - Hôpital le Bocage
Dijon, 21000, France
CH de Dunkerque
Dunkirk, France
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, France
Hôpital de Libourne
Libourne, France
CHRU de LILLE - Claude Huriez
Lille, France
Hopital Saint Vincent-de-Paul
Lille, France
Centre Léon Bérard
Lyon, 69373, France
INSTITUT PAOLI CALMETTES - Service Hématologie
Marseille, France
Clinique du Pont de Chaume
Montauban, France
CH de Mulhouse Sud Alsace
Mulhouse, 68070, France
CHR d'Orléans
Orléans, France
Hopital Saint-Louis
Paris, France
Chu de Bordeaux - Hopital Haut-Leveque
Pessac, France
CHU Lyon Sud
Pierre-Bénite, France
CHU de Poitiers - Hôpital de La Milétrie
Poitiers, France
CH de Quimper Cornouaille
Quimper, 29107, France
CHU de Rennes - Hôpital de Pontchaillou
Rennes, France
Institut Curie - Site Saint-Cloud
Saint-Cloud, France
CHU de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
Chu Bretonneau
Tours, France
CHRU de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, France
Ch de Bretagne Atlantique
Vannes, France
Gustave Roussy Cancer Campus Grand Paris
Villejuif, France
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Guillaume MANSON, MD
Lymphoma Study Association
- STUDY CHAIR
Gilles CROCHET, MD
The Lymphoma Academic Research Organisation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2025
First Posted
May 29, 2025
Study Start
December 1, 2025
Primary Completion
March 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share