Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
NCT ID: NCT05832125
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2021-12-14
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia
NCT01488162
Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
NCT02618109
Clinico-biological Characterization and Survival of Patients With Adult T-cell Leukemia / Lymphoma (ATL) and Patients Chronically Infected With the HTLV-1 Virus (HTLV-OBS)
NCT05237245
MB-105 in Patients With CD5 Positive T-cell Lymphoma
NCT06534060
Transplantation After Complete Response In Patients With T-cell Lymphoma
NCT05444712
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Versailles Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Aurélie Cabannes-Hamy
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens Picardie
Amiens, , France
Chu Angers
Angers, , France
CH Annecy Genevois
Annecy, , France
Centre Hospitalier d'Argenteuil
Argenteuil, , France
Centre Hospitalier Montfavet Avignon
Avignon, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Hopital Avicenne
Bobigny, , France
CHU de Bordeaux
Bordeaux, , France
Centre Hospitalier Universitaire de CAEN
Caen, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
Hopital Henri Mondor
Créteil, , France
CHU Dijon Bourgogne
Dijon, , France
CHU Lille
Lille, , France
Chu Limoges
Limoges, , France
Hospices Civiles de Lyon
Lyon, , France
Grand Hopital de l'Est Francilien
Meaux, , France
CHU de Montpellier
Montpellier, , France
Centre Hospitalier Emile Muller de Mulhouse
Mulhouse, , France
CHU Nancy
Nancy, , France
Centre anti-cancer Nice : Antoine Lacassagne
Nice, , France
CHU de Nice
Nice, , France
CHU Nîmes
Nîmes, , France
Hopital Saint-Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Centre Hospitalier de Perpignan
Perpignan, , France
CHU de Rennes
Rennes, , France
CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire
Saint-Etienne, , France
ONCOPOLE
Toulouse, , France
Centre Hospitalier de Versailles
Versailles, , France
Institut Gustave Roussy
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
LEBON
Role: primary
HUNAULT
Role: primary
MAUZ
Role: primary
PAPOULAR
Role: primary
CHEBREK
Role: primary
BANOS
Role: primary
BRAUN
Role: primary
LEGUAY
Role: primary
CHANTEPIE
Role: primary
CACHEUX
Role: primary
RONCHETTI
Role: primary
MAURY
Role: primary
CAILLOT
Role: primary
BERTON
Role: primary
TURLURE
Role: primary
BALSAT
Role: primary
FAYER
Role: primary
GEHLKOPF
Role: primary
LAMARQUE
Role: primary
BONMATI
Role: primary
GASTAUD
Role: primary
CLUZEAU
Role: primary
WICKENHAUSER
Role: primary
BRISSOT
Role: primary
DECROOCQ
Role: primary
KARANGWA
Role: primary
ESCOFFRE BARBE
Role: primary
TAVERNIER
Role: primary
HUGUET
Role: primary
Aurélie CABANNES-HAMY
Role: primary
PASQUIER
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P21/01_ALL TARGET OBS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.