Clinical trial NCT04328298: French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)
Official title: French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopathology Eligible or CAR-t Cell Treatment
Lead sponsor: The Lymphoma Academic Research Organisation
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Novartis
name: Bristol-Myers Squibb
First posted: 2020-03-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient eligible for a treatment with CAR-T for an hematological malignancy

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.


Eligibility criteria: Inclusion Criteria:

Retrospective inclusion :

* 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

Prospective inclusion :

* 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.

Exclusion Criteria Patient not registered with the social security in France

Primary outcomes:
measure: overall survival from eligibility
timeFrame: 15 years
measure: Overall survival from administration
timeFrame: 15 years
measure: complete response rate
timeFrame: 15 years
measure: Progression free survival
timeFrame: 15 years
measure: Duration of response
timeFrame: 15 years
measure: Delays between patient eligibility and CAR-T treatment
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens - Hôpital Sud
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHRU Besançon - Hôpital Minjoz
city: Brest
country: France
facility: CHU de Brest - Hôpital du Morvan
city: Caen
country: France
facility: Institut d'Hématologie de Basse Normandie
city: Clermont-Ferrand
country: France
facility: CHU d'Estaing
city: Créteil
country: France
facility: APHP - Hôpital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: La Tronche
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Hurriez
city: Limoges
country: France
facility: Hôpital Dupuytren
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP)
city: Marseille
country: France
facility: Hôpital de la Timone
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Paris
country: France
facility: APHP - Hôpital La Pitié Salpêtrière
city: Paris
country: France
facility: APHP - Hôpital Necker
city: Paris
country: France
facility: APHP - Hôpital Saint Antoine
city: Paris
country: France
facility: APHP - Hôpital Saint Louis
city: Paris
country: France
facility: APHP - Hôpital Universitaire Robert Debré
city: Pessac
country: France
facility: Centre Francois Magendie
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Hôpital de la Milétrie - CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU de Rouen Normandie
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Hématologie Universitaire de Saint Etienne
city: Strasbourg
country: France
facility: ICANS (Institut de Cancérologie Strasbourg Europe)
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
city: Tours
country: France
facility: CHU Bretonneau
city: Vandoeuvre les Nancy
country: France
facility: CHU Brabois
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus
Study officials:
affiliation: Institut Curie
name: Steven LE GOUILL, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Pontchaillou
name: Roch HOUOT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.