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Large B-cell LymphomaNCT06994169

Glofitamab in Real Life

An observational study of Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
Glofitamab
How many people
250 participants
Where
30 sitesFrance
Study dates
1 Dec 2025to 30 Dec 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

PROJECT MANAGER contact

+33 4 72 66 93 33

glorel@lysarc.org

30 sites in 1 country

France30 sites, 30 recruiting

  • CH Victor Dupouy

    Argenteuil, 95100

    Driss CHAOUI, MD

    Recruiting

  • CH d'Avignon - Hôpital Henri Dufaut

    Avignon, 84000

    Hacene ZERAZHI, MD

    Recruiting

  • CH de la Côte Basque

    Bayonne

    Sophie BERNARD, MD

    Recruiting

  • CHRU Besançon - Hôpital Minjoz

    Besançon

    Adrien CHAUCHET, MD

    Recruiting

  • Hopital D'Instruction Des Armees Percy

    Clamart, 92141

    Xavier PHINA-ZIEBIN

    Recruiting

  • Hopital Henri Mondor

    Créteil

    François LEMONNIER, MD

    Recruiting

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21000

    Cédric ROSSI, MD

    Recruiting

  • CH de Dunkerque

    Dunkirk

    Christophe FRUCHART, MD

    Recruiting

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche

    Sylvain CARRAS, MD

    Recruiting

  • Hôpital de Libourne

    Libourne

    Gaelle LABOURE, MD

    Recruiting

  • CHRU de LILLE - Claude Huriez

    Lille

    Franck MORSHHAUSER, MD

    Recruiting

  • Hopital Saint Vincent-de-Paul

    Lille

    Sandy AMORIM, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69373

    Laure LEBRAS, MD

    Recruiting

  • INSTITUT PAOLI CALMETTES - Service Hématologie

    Marseille

    Gabriel BRISOU, MD

    Recruiting

  • Clinique du Pont de Chaume

    Montauban

    Reda TABRIZI, MD

    Recruiting

  • CH de Mulhouse Sud Alsace

    Mulhouse, 68070

    Bernard DRENOU, MD

    Recruiting

  • CHR d'Orléans

    Orléans

    Marlène OCHMANN, MD

    Recruiting

  • Hopital Saint-Louis

    Paris

    Catherine THIEBLEMONT, MD

    Recruiting

  • Chu de Bordeaux - Hopital Haut-Leveque

    Pessac

    François-Xavier GROS, MD

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite

    Hervé GHESQUIERES, MD

    Recruiting

  • CHU de Poitiers - Hôpital de La Milétrie

    Poitiers

    Stéphanie GUIDEZ, MD

    Recruiting

  • CH de Quimper Cornouaille

    Quimper, 29107

    Ronan LE CALLOCH, MD

    Recruiting

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes

    Roch HOUOT, MD

    Recruiting

  • Institut Curie - Site Saint-Cloud

    Saint-Cloud

    Clémentine SARKOZY, MD

    Recruiting

  • CHU de Strasbourg

    Strasbourg

    Luc-Mathieu FORNECKER, MD

    Recruiting

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse

    Loïc YSEBAERT, MD

    Recruiting

  • Chu Bretonneau

    Tours

    Laurianne DRIEU LA ROCHELLE, MD

    Recruiting

  • CHRU de Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy

    Pierre FEUGIER, MD

    Recruiting

  • Ch de Bretagne Atlantique

    Vannes

    Antoine BONNET, MD

    Recruiting

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif

    Vincent RIBRAG, MD

    Recruiting

Other trials in France

About this study

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].

Being tested
Glofitamab
Keywords
CAR-T, Glofitamab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Glofitamab received for DLBCL in Early Phase Access

Study groups in NCT06994169
Study groupRoleWhat they receive
Patients treated in EPAPatients treated in Expanded Access Program to Glofitamab
Receives: Drug: Glofitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (9)

  1. Complete metabolic response rate and overall response rate (ORR) by investigator assessment according to Lugano 2014 criteria

    Measured: 1 month, 2 months, 3 months, 6 months

  2. Progression-free survival (PFS)

    Measured: 6 months

  3. Event-Free Survival (EFS)

    Measured: 6 months

  4. Overall survival (OS)

    Measured: 6 months

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

    Measured: 6 months

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

    Measured: 6 months

  7. intensive care unit (ICU) admission rate

    Measured: 6 months

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

    Measured: 6 months

  9. number of significant medical events leading to hospitalization

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start1 Dec 2025
  3. Primary completion27 Mar 2026
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
250 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06994169
Sponsor's protocol ID
GloRel
Status last verified
Jun 2026
First submitted
20 May 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Large B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 30 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact PROJECT MANAGER (+33 4 72 66 93 33, glorel@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Complete Response Rate (best CRR) during treatment, assessed by investigator according to Lugano 2014 criteria. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06994169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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