Glofitamab in Real Life

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT06994169
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab received for DLBCL in Early Phase Access

Study Details

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 \[8, 15\].

Key Dates

Start date
Dec 1, 2025
Status verified
Jun 2026
Primary completion
Mar 27, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Patients treated in EPA
    Patients treated in Expanded Access Program to Glofitamab

Primary Outcome Measure

Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria. [ Time Frame: 6 months ]

Central Contacts

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