Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05832125 Statut inconnu

Titre

Observatory for Patients Treated for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia With Oncogenetic Features.

Type

Observational [Patient Registry]

Pathologie

Leucémies
Leucémie lymphoïde
Leucémie-lymphome lymphoblastique à précurseurs B et T
Leucémie-lymphome lymphoblastique à précurseurs T

Phase

Promoteur

Versailles Hospital (Voir sur ClinicalTrials)

Date de début

décembre 2021

Date de fin

mars 2024

Dernière mise à jour

14 septembre 2025

Résumé

In order to improve the outcome of relapsed and/or refractory T-cell precursor acute lymphoblastic leukemia (T-ALL) patients, and to facilitate the use of oncogenetic targeted therapies in these patients, we set up an observational cohort, collecting clinical and biological information's from patients with T-ALL in relapse or refractory, as well as the use or not of a targeted therapy. The analysis of the cohort will allow us to evaluate the impact of this therapeutic strategies on the patients' fate, and to facilitate access to innovation and personalized medicine for these patients.

Détail

Voir le détail Depending on protocol and leukemia subtype, 5-10% of T-ALL patients are primary refractory, and 30-40% of patients will relapse. A new complete remission is attained in 20-40% of patients, but prolonged disease-free survival is observed in only 10-15% of cases. Nelarabine is approved for R/R T-ALL in second relapses, with a CR rate of 36% in the registration study, and an overall survival of 24% at 1 year and 12% at 3 years. The biological landscape of T-ALL is well characterized, with the identification of at least 10 key recurrently mutated pathways including transcriptional regulation (91% of cases), cell cycle regulation and tumor suppression (84%), NOTCH1 signaling (79%), epigenetic regulation (68%), PI3K-AKT-mTOR signaling (29%), JAK/STAT signaling (25%), RAS signaling (14%), ribosomal function (13%), ubiquitination (9%) and RNA processing (9%). Furthermore, T-ALL cells are dependent upon BCL-XL and upon BCL-2, especially when the T-ALL blasts bear an ETP phenotype. However, genomic data cannot reliably predict the response of leukemic cells to a given treatment, due to interactions of the different cellular pathways affected in a living leukemic cell. Therefore, the combination of genotypic and phenotypic data may overcome this problem. In France, patients with relapsed or refractory T-ALL (and also T-cell lymphoblastic lymphomas) are already proposed to undergo a genotypic (oncogenetic characterization) and a phenotypic (drug testing assay) characterization as a standard of care procedure. Based on the results obtained in fresh leukemic cells, a national scientific committee may recommend the used of targeted drugs alone or in combination, in the context of a "off-label" or a "compassionate" use (for example : Temsirolimus + Erwiniase + Venetoclax in PI3K-AKT-mTOR mutated ALL / Tofacitinib + Venetoclax in IL7R-JAK-STAT mutated ALL / 5-azacytidine + Venetocax in hypermethylated ALL / ...). All patients who undergone this procedure will be proposed to be registered in the ALL-Target registry (ALL-target Observatory). After registration, data related to disease history, disease characterization and disease treatment as well as data describing the patient's condition will be collected. Some patients may receive conventional chemotherapy as a salvage (conventional cohort), others may receive targeted therapy as a salvage (personalized medicine cohort). The aim of the registry is to evaluate the benefit of each treatment strategy in term of response as a primary end point. Comparison between the two cohorts will be performed after adjustment for confounding factors. Results of subgroups will also be reported using descriptive statistics. Secondary endpoints will include safety of the treatment strategy, survival, disease free survival and progression free survival. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne	BRAUN	En recrutement IDF	Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin	DECROOCQ	En recrutement IDF	Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Antoine	BRISSOT	En recrutement IDF	Contact (sur clinicalTrials)
CENTRE HOSPITALIER SUD FRANCILIEN	RONCHETTI	En recrutement IDF	Contact (sur clinicalTrials)
CH DE VERSAILLES SITE ANDRE MIGNOT	Aurélie CABANNES-HAMY	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre anti-cancer Nice : Antoine Lacassagne - Nice - France	GASTAUD	Recrutement non commencé	Contact (sur clinicalTrials)
Centre Hospitalier d'Argenteuil - Argenteuil - France	PAPOULAR	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier de la Cote Basque - Bayonne - France	BANOS	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier de Perpignan - Perpignan - France	KARANGWA	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Emile Muller de Mulhouse - Mulhouse - France	LAMARQUE	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Montfavet Avignon - Avignon - France	CHEBREK	En recrutement	Contact (sur clinicalTrials)
Centre Hospitalier Universitaire de CAEN - Caen - France	CHANTEPIE	En recrutement	Contact (sur clinicalTrials)
CH Annecy Genevois - Annecy - France	MAUZ	En recrutement	Contact (sur clinicalTrials)
CHU Amiens Picardie - Amiens - France	LEBON	En recrutement	Contact (sur clinicalTrials)
Chu Angers - Angers - France	HUNAULT	En recrutement	Contact (sur clinicalTrials)
CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire - Saint-Étienne - France	TAVERNIER	En recrutement	Contact (sur clinicalTrials)
CHU Clermont Ferrand - Clermont-Ferrand - France	CACHEUX	En recrutement	Contact (sur clinicalTrials)
CHU de Bordeaux - Bordeaux - France	LEGUAY	En recrutement	Contact (sur clinicalTrials)
CHU de Montpellier - Montpellier - France	GEHLKOPF	En recrutement	Contact (sur clinicalTrials)
CHU de Nice - Nice - France	CLUZEAU	En recrutement	Contact (sur clinicalTrials)
CHU de Rennes - Rennes - France	ESCOFFRE BARBE	En recrutement	Contact (sur clinicalTrials)
CHU Dijon Bourgogne - Dijon - France	CAILLOT	En recrutement	Contact (sur clinicalTrials)
CHU Lille - Lille - France	BERTON	En recrutement	Contact (sur clinicalTrials)
Chu Limoges - Limoges - France	TURLURE	En recrutement	Contact (sur clinicalTrials)
CHU Nancy - Nancy - France	BONMATI	En recrutement	Contact (sur clinicalTrials)
CHU Nîmes - Nîmes - France	WICKENHAUSER	En recrutement	Contact (sur clinicalTrials)
Grand Hopital de l'Est Francilien - Meaux - France	FAYER	En recrutement	Contact (sur clinicalTrials)
Hopital Henri Mondor - Créteil - France	MAURY	En recrutement	Contact (sur clinicalTrials)
Hospices Civiles de Lyon - Lyon - France	BALSAT	En recrutement	Contact (sur clinicalTrials)
Institut Gustave Roussy - Villejuif - France	PASQUIER	En recrutement	Contact (sur clinicalTrials)
ONCOPOLE - Toulouse - France	HUGUET	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Patients 18 years of age or older

- Patients with relapsed or refractory T-cell precursor ALL or T-cell lymphoblastic
lymphoma

- Oncogenetic analysis performed at diagnosis and/or relapse in the central laboratory

Critère de non inclusion

- Patient who refuse to be registered

NCT05832125 - Observatory for Patients Treated for Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia With Oncogenetic Features.

Informations générales
Etablissements
Critères
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