Glofitamab in Real Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Glofitamab.
- Who it may be relevant to
- Registry conditions: Large B-cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 \[8, 15\].
Interventions
- Drug Glofitamab
Glofitamab received for DLBCL in Early Phase Access
Primary outcome measures
- Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria. [Time frame: 6 months]
Secondary outcome measures (9)
- Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria [Time frame: 1 month, 2 months, 3 months, 6 months]
- Progression-free survival (PFS) [Time frame: 6 months]
- Event-Free Survival (EFS) [Time frame: 6 months]
- Overall survival (OS) [Time frame: 6 months]
- immune effector cell-associated neurotoxicity syndrome (ICANS) rate [Time frame: 6 months]
- ≥ grade 2 Cytokine release syndrome (CRS) rate [Time frame: 6 months]
- intensive care unit (ICU) admission rate [Time frame: 6 months]
- rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab, [Time frame: 6 months]
- number of significant medical events leading to hospitalization [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 30 centers
- CH Victor Dupouy — Argenteuil
- CH d'Avignon - Hôpital Henri Dufaut — Avignon
- CH de la Côte Basque — Bayonne
- CHRU Besançon - Hôpital Minjoz — Besançon
- Hopital D'Instruction Des Armees Percy — Clamart
- Hopital Henri Mondor — Créteil
- CHU de Dijon - Hôpital le Bocage — Dijon
- CH de Dunkerque — Dunkirk
- … and 22 more centers
Identifiers
NCT: NCT06994169 · GloRel