Large B-cell Lymphoma
Conditions
Keywords
CAR-T, Glofitamab
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 \[8, 15\].
Interventions
DRUGGlofitamab
Glofitamab received for DLBCL in Early Phase Access
Sponsors
The Lymphoma Academic Research Organisation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| ≥ grade 2 Cytokine release syndrome (CRS) rate | 6 months |
| intensive care unit (ICU) admission rate | 6 months |
| rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab, | 6 months |
| number of significant medical events leading to hospitalization | 6 months |
Countries
France
Contacts
CONTACTPROJECT MANAGER
STUDY_CHAIRGuillaume MANSON, MD
Lymphoma Study Association
STUDY_CHAIRGilles CROCHET, MD
The Lymphoma Academic Research Organisation
Outcome results
None listed