Informations générales (source: ClinicalTrials.gov)
A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA) (MTSA)
Interventional
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
janvier 2019
décembre 2027
10 avril 2025
This study aims at evaluating the safety and the tolerance of the micro-transplantation
in elderly patients with acute myeloid leukemia who are ineligible to conventional
allogeneic transplantation.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Nancy - Nancy - France | Arnaud Campidelli, MD | Contact (sur clinicalTrials) | |||
| CHU Estaing - 63000 - Clermont-Ferrand - France | Jacques-Olivier Bay, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Lyon Sud - Lyon - France | Hélène Labussière-Wallet, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Grenoble - Grenoble - France | Claude-Eric Bulabois, MD | Contact (sur clinicalTrials) | |||
| CHRU de Lille - Lille - France | Micha Srour | Contact (sur clinicalTrials) | |||
| CHU de Saint-Etienne - 42055 - Saint-Étienne - France | Jérôme Cornillon, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Pitié-Salpêtrière - Paris - France | Stéphanie Nguyen, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or
secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with
established myelodysplasic syndromes (RAEB), in pathologically confirmed complete
remission following anti-leukemic induction therapy (<5% blasts)
- Contra-indication to conditioning regimen in conventional allogeneic transplantation
- Patient affiliated to a social security regimen or beneficiary of the same
- Signed written informed consent form
- Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or
secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with
established myelodysplasic syndromes (RAEB), in pathologically confirmed complete
remission following anti-leukemic induction therapy (<5% blasts)
- Contra-indication to conditioning regimen in conventional allogeneic transplantation
- Patient with established diagnosis of acute myeloid leukemia with standard-risk
cytogenetic profile
- Promyelocytic leukemia t(15;17)
- CBF-AML t(8;21) or inv(16)
- Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3-
and double mutation CEBPα or chronic myeloid leukemia in blastic phase
- Patient under guardianship or deprived of his liberty or any condition that may
affect the patient's ability to understand and sign the informed consent
- Refusing participation