Trial Title:
Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
NCT ID:
NCT05832125
Condition:
Relapsed/Refractory Acute Lymphoblastic Leukemia
T-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Patients 18 years of age or older, with relapsed or refractory T cell precursor-ALL or
T-cell Lymphoblastic lymphoma, with oncogenetic analysis performed at diagnosis and/or
relapse in the central laboratory.
Sampling method:
Probability Sample
Criteria:
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
Exclusion Criteria:
- Patient who refuse to be registered
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Amiens Picardie
Address:
City:
Amiens
Country:
France
Status:
Recruiting
Contact:
Last name:
LEBON
Facility:
Name:
Chu Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
HUNAULT
Facility:
Name:
CH Annecy Genevois
Address:
City:
Annecy
Country:
France
Status:
Recruiting
Contact:
Last name:
MAUZ
Facility:
Name:
Centre Hospitalier d'Argenteuil
Address:
City:
Argenteuil
Country:
France
Status:
Recruiting
Contact:
Last name:
PAPOULAR
Facility:
Name:
Centre Hospitalier Montfavet Avignon
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Contact:
Last name:
CHEBREK
Facility:
Name:
Centre Hospitalier de la Cote Basque
Address:
City:
Bayonne
Country:
France
Status:
Recruiting
Contact:
Last name:
BANOS
Facility:
Name:
Hopital Avicenne
Address:
City:
Bobigny
Country:
France
Status:
Recruiting
Contact:
Last name:
BRAUN
Facility:
Name:
CHU de Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Contact:
Last name:
LEGUAY
Facility:
Name:
Centre Hospitalier Universitaire de CAEN
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
CHANTEPIE
Facility:
Name:
CHU Clermont Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Status:
Recruiting
Contact:
Last name:
CACHEUX
Facility:
Name:
Centre Hospitalier Sud Francilien
Address:
City:
Corbeil-Essonnes
Country:
France
Status:
Recruiting
Contact:
Last name:
RONCHETTI
Facility:
Name:
Hopital Henri Mondor
Address:
City:
Créteil
Country:
France
Status:
Recruiting
Contact:
Last name:
MAURY
Facility:
Name:
CHU Dijon Bourgogne
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
CAILLOT
Facility:
Name:
CHU Lille
Address:
City:
Lille
Country:
France
Status:
Recruiting
Contact:
Last name:
BERTON
Facility:
Name:
Chu Limoges
Address:
City:
Limoges
Country:
France
Status:
Recruiting
Contact:
Last name:
TURLURE
Facility:
Name:
Hospices Civiles de Lyon
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Contact:
Last name:
BALSAT
Facility:
Name:
Grand Hopital de l'Est Francilien
Address:
City:
Meaux
Country:
France
Status:
Recruiting
Contact:
Last name:
FAYER
Facility:
Name:
CHU de Montpellier
Address:
City:
Montpellier
Country:
France
Status:
Recruiting
Contact:
Last name:
GEHLKOPF
Facility:
Name:
Centre Hospitalier Emile Muller de Mulhouse
Address:
City:
Mulhouse
Country:
France
Status:
Recruiting
Contact:
Last name:
LAMARQUE
Facility:
Name:
CHU Nancy
Address:
City:
Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
BONMATI
Facility:
Name:
Centre anti-cancer Nice : Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
GASTAUD
Facility:
Name:
CHU de Nice
Address:
City:
Nice
Country:
France
Status:
Recruiting
Contact:
Last name:
CLUZEAU
Facility:
Name:
CHU Nîmes
Address:
City:
Nîmes
Country:
France
Status:
Recruiting
Contact:
Last name:
WICKENHAUSER
Facility:
Name:
Hopital Saint-Antoine
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
BRISSOT
Facility:
Name:
Hôpital Cochin
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
DECROOCQ
Facility:
Name:
Centre Hospitalier de Perpignan
Address:
City:
Perpignan
Country:
France
Status:
Recruiting
Contact:
Last name:
KARANGWA
Facility:
Name:
CHU de Rennes
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
ESCOFFRE BARBE
Facility:
Name:
CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire
Address:
City:
Saint-Étienne
Country:
France
Status:
Recruiting
Contact:
Last name:
TAVERNIER
Facility:
Name:
ONCOPOLE
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
HUGUET
Facility:
Name:
Centre Hospitalier de Versailles
Address:
City:
Versailles
Country:
France
Status:
Recruiting
Contact:
Last name:
Aurélie CABANNES-HAMY
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
PASQUIER
Start date:
December 14, 2021
Completion date:
March 2024
Lead sponsor:
Agency:
Versailles Hospital
Agency class:
Other
Source:
Versailles Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832125
