Clinical trial NCT06994169: Glofitamab in Real Life
Official title: Glofitamab in Real Life
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Large B-cell Lymphoma
Keywords: CAR-T
Glofitamab
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 \[8, 15\].


Eligibility criteria: 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

Primary outcomes:
measure: Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.
timeFrame: 6 months
Secondary outcomes:
measure: Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria
timeFrame: 1 month, 2 months, 3 months, 6 months
measure: Progression-free survival (PFS)
timeFrame: 6 months
measure: Event-Free Survival (EFS)
timeFrame: 6 months
measure: Overall survival (OS)
timeFrame: 6 months
measure: immune effector cell-associated neurotoxicity syndrome (ICANS) rate
timeFrame: 6 months
measure: ≥ grade 2 Cytokine release syndrome (CRS) rate
timeFrame: 6 months
measure: intensive care unit (ICU) admission rate
timeFrame: 6 months
measure: rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab,
timeFrame: 6 months
measure: number of significant medical events leading to hospitalization
timeFrame: 6 months
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: Avignon
country: France
facility: CH d'Avignon - Hôpital Henri Dufaut
city: Bayonne
country: France
facility: CH de la Côte Basque
city: Besançon
country: France
facility: CHRU Besançon - Hôpital Minjoz
city: Clamart
country: France
facility: Hopital D'Instruction Des Armees Percy
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon - Hôpital le Bocage
city: Dunkerque
country: France
facility: CH de Dunkerque
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
city: Libourne
country: France
facility: Hôpital de Libourne
city: Lille
country: France
facility: CHRU de LILLE - Claude Huriez
city: Lille
country: France
facility: Hopital Saint Vincent-de-Paul
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: INSTITUT PAOLI CALMETTES - Service Hématologie
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Mulhouse
country: France
facility: CH de Mulhouse Sud Alsace
city: Orleans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: Hopital Saint-Louis
city: Pessac
country: France
facility: Chu de Bordeaux - Hopital Haut-Leveque
city: Pierre-bénite
country: France
facility: CHU Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de La Milétrie
city: Quimper
country: France
facility: CH de Quimper Cornouaille
city: Rennes
country: France
facility: CHU de Rennes - Hôpital de Pontchaillou
city: Saint-Cloud
country: France
facility: Institut Curie - Site Saint-Cloud
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
city: Tours
country: France
facility: Chu Bretonneau
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Hôpital de Brabois
city: Vannes
country: France
facility: Ch de Bretagne Atlantique
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris
Study officials:
affiliation: Lymphoma Study Association
name: Guillaume MANSON, MD
role: STUDY_CHAIR
affiliation: The Lymphoma Academic Research Organisation
name: Gilles CROCHET, MD
role: STUDY_CHAIR
References: