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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05832125
Other study ID # P21/01_ALL TARGET OBS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 14, 2021
Est. completion date March 2024

Study information

Verified date April 2023
Source Versailles Hospital
Contact Aurélie CABANNES-HAMY
Phone +33139638909
Email acabannes@ght78sud.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • Relapsed/Refractory Acute Lymphoblastic Leukemia
  • T-cell Acute Lymphoblastic Leukemia

Locations

Country Name City State
France 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 Hôpital Cochin Paris
France Hopital Saint-Antoine Paris
France Centre Hospitalier de Perpignan Perpignan
France CHU de Rennes Rennes
France CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire Saint-Étienne
France ONCOPOLE Toulouse
France Centre Hospitalier de Versailles Versailles
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate defined as complete remission and remission without complete hematological recovery (CR + CRi). Response rate defined as complete remission and remission without complete hematological recovery (CR + CRi). 3 months
Secondary Performance Status of patients Eastern Cooperative Oncology Group (ECOG) - Performans Status Scale PS 0 : Fully active, able to carry on all pre-disease performance without restriction PS 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 3 months
Secondary Biological description of T-ALL Phenotypic and oncogenetic characterization with mutated signaling pathways 3 months
Secondary Description of the treatments received Number and type of treatment lines received, including current treatment 3 months
Secondary Description of Overall response rate to treatment Overall response rate defined by partial response rate + complete response rate 2 years
Secondary Description of the relapse rate Event of relapse 2 years
Secondary Description of survival rate Death 2 years
Secondary Duration of response Response 2 years
Secondary Description of Adverse Events Adverse Events 2 years
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