NCT04328298

Brief Summary

This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
153mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

36 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Dec 2019Dec 2038

Study Start

First participant enrolled

December 19, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2038

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2038

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

19 years

First QC Date

March 27, 2020

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • overall survival from eligibility

    15 years

  • Overall survival from administration

    15 years

  • complete response rate

    15 years

  • Progression free survival

    15 years

  • Duration of response

    15 years

  • Delays between patient eligibility and CAR-T treatment

    15 years

Eligibility Criteria

Age0 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient eligible for a treatment with CAR-T for an hematological malignancy

You may qualify if:

  • Patient treated with CAR-T from 1 July 2018 under temporary authorization (ATU) or covered by French health insurance system (under post-ATU or MA) in a qualified center before activation of this register in this center
  • If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive
  • Patient eligible for a treatment with CAR-T for an hematological malignancy which is covered by French health insurance (for ATUs / post-ATUs or MA), or as part of a clinical trial with the same indication, after the activation of this register in this center.
  • Patient whose CAR-T indication has been validated during a multidisciplinary tumor board (RCP) of a qualified center, according to the ministerial order of 8 August 2019
  • Patient deemed eligible for a treatment with CAR-T after a medical exam performed in a qualified center according to the ministerial order of 8 August 2019
  • If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

CHU d'Amiens - Hôpital Sud

Amiens, France

RECRUITING

CHU Angers

Angers, France

RECRUITING

CHRU Besançon - Hôpital Minjoz

Besançon, France

RECRUITING

CHU de Brest - Hôpital du Morvan

Brest, France

RECRUITING

Institut d'Hématologie de Basse Normandie

Caen, France

RECRUITING

CHU d'Estaing

Clermont-Ferrand, France

RECRUITING

APHP - Hôpital Henri Mondor

Créteil, France

RECRUITING

CHU de Dijon

Dijon, France

RECRUITING

CHU de Grenoble

La Tronche, France

RECRUITING

CHRU de Lille - Hôpital Claude Hurriez

Lille, France

RECRUITING

Hôpital Dupuytren

Limoges, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)

Lyon, France

RECRUITING

Hôpital de la Timone

Marseille, France

RECRUITING

Institut Paoli Calmette

Marseille, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, France

RECRUITING

CHU de Nice

Nice, France

RECRUITING

APHP - Hôpital Cochin

Paris, France

RECRUITING

APHP - Hôpital La Pitié Salpêtrière

Paris, France

RECRUITING

APHP - Hôpital Necker

Paris, France

RECRUITING

APHP - Hôpital Saint Antoine

Paris, France

RECRUITING

APHP - Hôpital Saint Louis

Paris, France

RECRUITING

APHP - Hôpital Universitaire Robert Debré

Paris, France

RECRUITING

Centre Francois Magendie

Pessac, France

RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

RECRUITING

Hôpital de la Milétrie - CHU de Poitiers

Poitiers, France

RECRUITING

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

CHU de Rouen Normandie

Rouen, France

RECRUITING

Institut de Cancérologie Hématologie Universitaire de Saint Etienne

Saint-Priest-en-Jarez, France

RECRUITING

ICANS (Institut de Cancérologie Strasbourg Europe)

Strasbourg, France

RECRUITING

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, France

RECRUITING

CHU Bretonneau

Tours, France

RECRUITING

CHU Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Gustave Roussy Cancer Campus

Villejuif, France

RECRUITING

Related Publications (3)

  • Cayla S, Karlin L, Lambert J, Lazareth A, Talbot A, Mohty M, Malard F, Petillon MO, Manier S, Yakoub-Agha I, Caillot D, Lafon I, Leleu X, Moya N, Royer B, Schiano De Colella JM, Brisou G, Touzeau C, Perrot A, Bories P, Vincent L, Guedon H, Decaux O, Ferment B, Houot R, Le Gouill S, Bigot N, Facon T, Corre J, Avet-Loiseau H, Moreau P, Arnulf B. Poor outcomes with BCMA-targeting bispecific antibodies following early relapse from ide-cel: a real-world French study. Blood Adv. 2026 Feb 24;10(4):1324-1333. doi: 10.1182/bloodadvances.2025017597.

  • Sesques P, Kirkwood AA, Kwon M, Rejeski K, Jain MD, Di Blasi R, Brisou G, Gros FX, le Bras F, Bories P, Choquet S, Rubio MT, Iacoboni G, O'Reilly M, Casasnovas RO, Bay JO, Mohty M, Joris M, Abraham J, Castilla Llorente C, Loschi M, Carras S, Chauchet A, La Rochelle LD, Hermine O, Guidez S, Cony-Makhoul P, Fogarty P, Le Gouill S, Morschhauser F, Gastinne T, Cartron G, Subklewe M, Locke FL, Sanderson R, Barba P, Houot R, Bachy E. Novel prognostic scoring systems for severe CRS and ICANS after anti-CD19 CAR T cells in large B-cell lymphoma. J Hematol Oncol. 2024 Aug 6;17(1):61. doi: 10.1186/s13045-024-01579-w.

  • Bachy E, Le Gouill S, Di Blasi R, Sesques P, Manson G, Cartron G, Beauvais D, Roulin L, Gros FX, Rubio MT, Bories P, Bay JO, Llorente CC, Choquet S, Casasnovas RO, Mohty M, Guidez S, Joris M, Loschi M, Carras S, Abraham J, Chauchet A, Drieu La Rochelle L, Deau-Fischer B, Hermine O, Gastinne T, Tudesq JJ, Gat E, Broussais F, Thieblemont C, Houot R, Morschhauser F. A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma. Nat Med. 2022 Oct;28(10):2145-2154. doi: 10.1038/s41591-022-01969-y. Epub 2022 Sep 22.

Study Officials

  • Steven LE GOUILL, Pr

    Institut Curie

    PRINCIPAL INVESTIGATOR
  • Roch HOUOT, Pr

    CHU Pontchaillou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

December 19, 2019

Primary Completion (Estimated)

December 19, 2038

Study Completion (Estimated)

December 19, 2038

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations