Health TrialsbyHealthPanel

Glofitamab in Real Life

ConditionLarge B-cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

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 \[8, 15\].

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

none

Trial population

French patients enrolled in the EAP before 1st of November 2024 and treated with at least Obinutuzumab pretreatment and one infusion of Glofitamab for R/R DLBCL We expect to collect data from 200-250 patients from this population with a minimum of 6 months of follow-up.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Glofitamab

    Drug

    Glofitamab received for DLBCL in Early Phase Access

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Patients treated in EPA1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months

Secondary outcomes

1

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
2

Progression-free survival (PFS)

Time frame
6 months
3

Event-Free Survival (EFS)

Time frame
6 months
4

Overall survival (OS)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Lymphoma Academic Research Organisation

Lead sponsor

Source ClinicalTrials.gov
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