NCT05832125

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

31 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 13, 2023

Last Update Submit

April 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Performance Status of patients

    3 months

  • Biological description of T-ALL

    3 months

  • Description of the treatments received

    3 months

  • Description of Overall response rate to treatment

    2 years

  • Description of the relapse rate

    2 years

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Patient who refuse to be registered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

CHU Amiens Picardie

Amiens, France

RECRUITING

Chu Angers

Angers, France

RECRUITING

CH Annecy Genevois

Annecy, France

RECRUITING

Centre Hospitalier d'Argenteuil

Argenteuil, France

RECRUITING

Centre Hospitalier Montfavet Avignon

Avignon, France

RECRUITING

Centre Hospitalier de la Cote Basque

Bayonne, France

RECRUITING

Hopital Avicenne

Bobigny, France

RECRUITING

CHU de Bordeaux

Bordeaux, France

RECRUITING

Centre Hospitalier Universitaire de CAEN

Caen, France

RECRUITING

CHU Clermont Ferrand

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

RECRUITING

Hopital Henri Mondor

Créteil, France

RECRUITING

CHU Dijon Bourgogne

Dijon, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

Chu Limoges

Limoges, France

RECRUITING

Hospices Civiles de Lyon

Lyon, France

RECRUITING

Grand Hopital de l'Est Francilien

Meaux, France

RECRUITING

CHU de Montpellier

Montpellier, France

RECRUITING

Centre Hospitalier Emile Muller de Mulhouse

Mulhouse, France

RECRUITING

CHU Nancy

Nancy, France

RECRUITING

Centre anti-cancer Nice : Antoine Lacassagne

Nice, France

NOT YET RECRUITING

CHU de Nice

Nice, France

RECRUITING

CHU Nîmes

Nîmes, France

RECRUITING

Hopital Saint-Antoine

Paris, France

RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

Centre Hospitalier de Perpignan

Perpignan, France

RECRUITING

CHU de Rennes

Rennes, France

RECRUITING

CHU Centre Hospitalier Universitaire de Saint-Étienne - Loire

Saint-Etienne, France

RECRUITING

ONCOPOLE

Toulouse, France

RECRUITING

Centre Hospitalier de Versailles

Versailles, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Aurélie CABANNES-HAMY

CONTACT

Mélody FORT

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 27, 2023

Study Start

December 14, 2021

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations