Glofitamab in Real Life

The Lymphoma Academic Research Organisation250 enrolled

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 \[8, 15\].

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Large B-cell Lymphoma

Interventions

GlofitamabDRUG

Glofitamab received for DLBCL in Early Phase Access

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

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

Outcomes

Primary Outcomes

Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria.

Time frame: 6 months

Secondary Outcomes

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

Glofitamab in Real Life

Overview

Conditions

Interventions

Eligibility

Locations (30)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts