T-cell Acute Lymphoblastic Leukemia Clinical Trial
— ALLTARGETOBSOfficial title:
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Versailles Hospital |
France,
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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