Real-world outcomes with glofitamab for large B-cell lymphoma
Glofitamab in Real Life
The Lymphoma Academic Research Organisation · NCT06994169
This project looks at how well glofitamab works and how safe it is for adults in France with relapsed or refractory large B‑cell lymphoma who were treated through the expanded access program.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Lymphoma Academic Research Organisation (other) |
| Drugs / interventions | Glofitamab, Obinutuzumab, CAR-T |
| Locations | 30 sites (Argenteuil and 29 other locations) |
| Trial ID | NCT06994169 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational analysis of over 300 adults treated with glofitamab in the French expanded-access program, with an expected median follow-up of more than nine months. The project will summarize real-world efficacy and safety outcomes across participating centers. Special attention is given to patients previously treated with CAR‑T therapy to confirm reported complete response rates and to explore optimal timing of glofitamab initiation. Included patients received obinutuzumab pretreatment and at least one glofitamab infusion and did not object to use of their data.
Who should consider this trial
Good fit: Adult patients enrolled in the French glofitamab expanded-access program before November 1, 2024 who received obinutuzumab pretreatment and at least one glofitamab infusion and who did not oppose data collection.
Not a fit: Patients not treated in the French EAP, pediatric patients, or those who did not receive obinutuzumab pretreatment or any glofitamab infusion are unlikely to be represented and therefore may not benefit from the study findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians better predict which patients benefit from glofitamab and inform optimal timing of treatment in relapsed/refractory large B‑cell lymphoma.
How similar studies have performed: Previous clinical trials and expanded-access reports have shown promising response rates for glofitamab, including reported CRR around 35–39% in CAR‑T‑exposed patients, but large real‑world cohorts are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Argenteuil and 29 other locations
- CH Victor Dupouy — Argenteuil, France (RECRUITING)
- CH d'Avignon - Hôpital Henri Dufaut — Avignon, France (RECRUITING)
- CH de la Côte Basque — Bayonne, France (RECRUITING)
- CHRU Besançon - Hôpital Minjoz — Besançon, France (RECRUITING)
- Hopital D'Instruction Des Armees Percy — Clamart, France (RECRUITING)
- Hopital Henri Mondor — Créteil, France (RECRUITING)
- CHU de Dijon - Hôpital le Bocage — Dijon, France (RECRUITING)
- CH de Dunkerque — Dunkirk, France (RECRUITING)
- CHU de Grenoble - Hôpital Albert Michallon — La Tronche, France (RECRUITING)
- Hôpital de Libourne — Libourne, France (RECRUITING)
- CHRU de LILLE - Claude Huriez — Lille, France (RECRUITING)
- Hopital Saint Vincent-de-Paul — Lille, France (RECRUITING)
- Centre Léon Bérard — Lyon, France (RECRUITING)
- INSTITUT PAOLI CALMETTES - Service Hématologie — Marseille, France (RECRUITING)
- Clinique du Pont de Chaume — Montauban, France (RECRUITING)
- CH de Mulhouse Sud Alsace — Mulhouse, France (RECRUITING)
- CHR d'Orléans — Orléans, France (RECRUITING)
- Hopital Saint-Louis — Paris, France (RECRUITING)
- Chu de Bordeaux - Hopital Haut-Leveque — Pessac, France (RECRUITING)
- CHU Lyon Sud — Pierre-Bénite, France (RECRUITING)
- CHU de Poitiers - Hôpital de La Milétrie — Poitiers, France (RECRUITING)
- CH de Quimper Cornouaille — Quimper, France (RECRUITING)
- CHU de Rennes - Hôpital de Pontchaillou — Rennes, France (RECRUITING)
- Institut Curie - Site Saint-Cloud — Saint-Cloud, France (RECRUITING)
- CHU de Strasbourg — Strasbourg, France (RECRUITING)
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (RECRUITING)
- Chu Bretonneau — Tours, France (RECRUITING)
- CHRU de Nancy - Hôpital de Brabois — Vandœuvre-lès-Nancy, France (RECRUITING)
- Ch de Bretagne Atlantique — Vannes, France (RECRUITING)
- Gustave Roussy Cancer Campus Grand Paris — Villejuif, France (RECRUITING)
Study contacts
- Study coordinator: PROJECT MANAGER
- Email: glorel@lysarc.org
- Phone: +33 4 72 66 93 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Large B-cell Lymphoma, CAR-T, Glofitamab