Glofitamab in Real Life

NCT ID: NCT06994169

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-07-30

Brief Summary

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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

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Conditions

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Large B-cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients treated in EPA

Patients treated in Expanded Access Program to Glofitamab

Glofitamab

Intervention Type DRUG

Glofitamab received for DLBCL in Early Phase Access

Interventions

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Glofitamab

Glofitamab received for DLBCL in Early Phase Access

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Lymphoma Academic Research Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume MANSON, MD

Role: STUDY_CHAIR

Lymphoma Study Association

Gilles CROCHET, MD

Role: STUDY_CHAIR

The Lymphoma Academic Research Organisation

Locations

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CH Victor Dupouy

Argenteuil, , France

Site Status RECRUITING

CH d'Avignon - Hôpital Henri Dufaut

Avignon, , France

Site Status RECRUITING

CH de la Côte Basque

Bayonne, , France

Site Status RECRUITING

CHRU Besançon - Hôpital Minjoz

Besançon, , France

Site Status RECRUITING

Hopital D'Instruction Des Armees Percy

Clamart, , France

Site Status RECRUITING

Hopital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHU de Dijon - Hôpital le Bocage

Dijon, , France

Site Status RECRUITING

CH de Dunkerque

Dunkirk, , France

Site Status RECRUITING

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, , France

Site Status RECRUITING

Hôpital de Libourne

Libourne, , France

Site Status RECRUITING

CHRU de LILLE - Claude Huriez

Lille, , France

Site Status RECRUITING

Hopital Saint Vincent-de-Paul

Lille, , France

Site Status RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

INSTITUT PAOLI CALMETTES - Service Hématologie

Marseille, , France

Site Status RECRUITING

Clinique du Pont de Chaume

Montauban, , France

Site Status RECRUITING

CH de Mulhouse Sud Alsace

Mulhouse, , France

Site Status RECRUITING

CHR d'Orléans

Orléans, , France

Site Status RECRUITING

Hopital Saint-Louis

Paris, , France

Site Status RECRUITING

Chu de Bordeaux - Hopital Haut-Leveque

Pessac, , France

Site Status RECRUITING

CHU Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

CHU de Poitiers - Hôpital de La Milétrie

Poitiers, , France

Site Status RECRUITING

CH de Quimper Cornouaille

Quimper, , France

Site Status RECRUITING

CHU de Rennes - Hôpital de Pontchaillou

Rennes, , France

Site Status RECRUITING

Institut Curie - Site Saint-Cloud

Saint-Cloud, , France

Site Status RECRUITING

CHU de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status RECRUITING

Chu Bretonneau

Tours, , France

Site Status RECRUITING

CHRU de Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Ch de Bretagne Atlantique

Vannes, , France

Site Status RECRUITING

Gustave Roussy Cancer Campus Grand Paris

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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PROJECT MANAGER

Role: CONTACT

+33 4 72 66 93 33

Facility Contacts

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Driss CHAOUI, MD

Role: primary

Hacene ZERAZHI, MD

Role: primary

Sophie BERNARD, MD

Role: primary

Adrien CHAUCHET, MD

Role: primary

Xavier PHINA-ZIEBIN

Role: primary

François LEMONNIER, MD

Role: primary

Cédric ROSSI, MD

Role: primary

Christophe FRUCHART, MD

Role: primary

Sylvain CARRAS, MD

Role: primary

Gaelle LABOURE, MD

Role: primary

Franck MORSHHAUSER, MD

Role: primary

Sandy AMORIM, MD

Role: primary

Laure LEBRAS, MD

Role: primary

Gabriel BRISOU, MD

Role: primary

Reda TABRIZI, MD

Role: primary

Bernard DRENOU, MD

Role: primary

Marlène OCHMANN, MD

Role: primary

Catherine THIEBLEMONT, MD

Role: primary

François-Xavier GROS, MD

Role: primary

Hervé GHESQUIERES, MD

Role: primary

Stéphanie GUIDEZ, MD

Role: primary

Ronan LE CALLOCH, MD

Role: primary

Roch HOUOT, MD

Role: primary

Clémentine SARKOZY, MD

Role: primary

Luc-Mathieu FORNECKER, MD

Role: primary

Loïc YSEBAERT, MD

Role: primary

Laurianne DRIEU LA ROCHELLE, MD

Role: primary

Pierre FEUGIER, MD

Role: primary

Antoine BONNET, MD

Role: primary

Vincent RIBRAG, MD

Role: primary

Other Identifiers

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GloRel

Identifier Type: -

Identifier Source: org_study_id

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