RecruitingNot ApplicableNCT03439371

Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

21 participants

Start Date

Jan 8, 2019

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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.

Eligibility

Min Age: 60 YearsMax Age: 75 Years

Inclusion Criteria4

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

Exclusion Criteria6

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