Status:
RECRUITING
Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Institut de Cancérologie de la Loire
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
NA
Brief 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.
Detailed Description
Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03439371
Start Date
January 8 2019
End Date
December 31 2027
Last Update
April 9 2025
Active Locations (7)
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1
CHU Estaing
Clermont-Ferrand, France, 63000
2
Centre Hospitalier Universitaire de Grenoble
Grenoble, France
3
CHRU de Lille
Lille, France
4
Centre Hospitalier Lyon Sud
Lyon, France