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NCT Number: NCT06994169

Glofitamab in Real Life

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].

Recruiting

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Key information

Conditions

Large B-cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Victor Dupouy, Argenteuil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glofitamab

Drug

Glofitamab received for DLBCL in Early Phase Access

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

  5. immune effector cell-associated neurotoxicity syndrome (ICANS) rate

    Time frame: 6 months

  6. ≥ grade 2 Cytokine release syndrome (CRS) rate

    Time frame: 6 months

  7. intensive care unit (ICU) admission rate

    Time frame: 6 months

  8. rate and cause of rehospitalization due to an adverse event potentially related to Glofitamab,

    Time frame: 6 months

  9. number of significant medical events leading to hospitalization

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

PROJECT MANAGER

CONTACT

[email protected]

+33 4 72 66 93 33

Sponsors and collaborators

Lead sponsor

The Lymphoma Academic Research Organisation

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 29, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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