Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (ALLTARGETOBS)

April 14, 2023 updated by: Aurélie Cabannes-Hamy, Versailles Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie
        • Contact:
          • LEBON
      • Angers, France
        • Recruiting
        • CHU angers
        • Contact:
          • HUNAULT
      • Annecy, France
        • Recruiting
        • Ch Annecy Genevois
        • Contact:
          • MAUZ
      • Argenteuil, France
        • Recruiting
        • Centre Hospitalier d'Argenteuil
        • Contact:
          • PAPOULAR
      • Avignon, France
        • Recruiting
        • Centre Hospitalier Montfavet Avignon
        • Contact:
          • CHEBREK
      • Bayonne, France
        • Recruiting
        • Centre Hospitalier de la Côte Basque
        • Contact:
          • BANOS
      • Bobigny, France
        • Recruiting
        • Hôpital Avicenne
        • Contact:
          • BRAUN
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • LEGUAY
      • Caen, France
        • Recruiting
        • Centre Hospitalier Universitaire de Caen
        • Contact:
          • CHANTEPIE
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Clermont Ferrand
        • Contact:
          • CACHEUX
      • Corbeil-Essonnes, France
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:
          • RONCHETTI
      • Créteil, France
        • Recruiting
        • Hopital Henri Mondor
        • Contact:
          • MAURY
      • Dijon, France
        • Recruiting
        • CHU Dijon Bourgogne
        • Contact:
          • CAILLOT
      • Lille, France
        • Recruiting
        • CHU Lille
        • Contact:
          • BERTON
      • Limoges, France
        • Recruiting
        • CHU Limoges
        • Contact:
          • TURLURE
      • Lyon, France
        • Recruiting
        • Hospices Civiles de Lyon
        • Contact:
          • BALSAT
      • Meaux, France
        • Recruiting
        • Grand Hôpital de l'Est Francilien
        • Contact:
          • FAYER
      • Montpellier, France
        • Recruiting
        • CHU de Montpellier
        • Contact:
          • GEHLKOPF
      • Mulhouse, France
        • Recruiting
        • Centre Hospitalier Emile Muller de Mulhouse
        • Contact:
          • LAMARQUE
      • Nancy, France
        • Recruiting
        • CHU Nancy
        • Contact:
          • BONMATI
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
          • CLUZEAU
      • Nice, France
        • Not yet recruiting
        • Centre anti-cancer Nice : Antoine Lacassagne
        • Contact:
          • GASTAUD
      • Nîmes, France
        • Recruiting
        • CHU Nîmes
        • Contact:
          • WICKENHAUSER
      • Paris, France
        • Recruiting
        • Hopital Saint-Antoine
        • Contact:
          • BRISSOT
      • Paris, France
        • Recruiting
        • Hôpital Cochin
        • Contact:
          • DECROOCQ
      • Perpignan, France
        • Recruiting
        • Centre Hospitalier de Perpignan
        • Contact:
          • KARANGWA
      • Rennes, France
        • Recruiting
        • CHU de Rennes
        • Contact:
          • ESCOFFRE BARBE
      • Saint-Étienne, France
        • Recruiting
        • CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire
        • Contact:
          • TAVERNIER
      • Toulouse, France
        • Recruiting
        • ONCOPOLE
        • Contact:
          • HUGUET
      • Versailles, France
        • Recruiting
        • Centre Hospitalier de Versailles
        • Contact:
          • Aurélie CABANNES-HAMY
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • PASQUIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate defined as complete remission and remission without complete hematological recovery (CR + CRi).
Time Frame: 3 months
Response rate defined as complete remission and remission without complete hematological recovery (CR + CRi).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Status of patients
Time Frame: 3 months
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
Biological description of T-ALL
Time Frame: 3 months
Phenotypic and oncogenetic characterization with mutated signaling pathways
3 months
Description of the treatments received
Time Frame: 3 months
Number and type of treatment lines received, including current treatment
3 months
Description of Overall response rate to treatment
Time Frame: 2 years
Overall response rate defined by partial response rate + complete response rate
2 years
Description of the relapse rate
Time Frame: 2 years
Event of relapse
2 years
Description of survival rate
Time Frame: 2 years
Death
2 years
Duration of response
Time Frame: 2 years
Response
2 years
Description of Adverse Events
Time Frame: 2 years
Adverse Events
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P21/01_ALL TARGET OBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on T-cell Acute Lymphoblastic Leukemia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe