Status:
ACTIVE_NOT_RECRUITING
A Study Comparing Allogeneic Hematopoietic Cell Transplantation Versus Best Available Standard of Care Therapy in Elderly Patients With Acute Myeloid Leukemia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
65-75 years
Phase:
NA
Brief Summary
A subject of major interest for researchers, clinicians, patients, and payers, is the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of these older patients wi...
Detailed Description
Every year, 30,000 patients in Europe and 20,000 in the USA are diagnosed with acute myeloid leukemia (AML). More than half of them are over 65 years old. In this older population, the median overall ...
Eligibility Criteria
Inclusion
- Men and women
- Age ≥ 65 and ≤ 75 years
- Newly diagnosed patients with de novo or secondary AML in first complete remission who are considered as potential candidates and eligible for an allo-HSCT procedure
- Presence of a donor (matched related or unrelated or haplo-mismatched) willing to donate peripheral blood stem cells
- Patient is fit for the allo-HSCT procedure
- Patient is fit for further consolidation therapy (non-transplant arm)
- Written informed consent
Exclusion
- Acute promyelocytic leukemia (AML FAB M3)
- AML deemed not eligible for allo-HSCT
- Karnofsky score \<70%
- HIV positive patient
- Life expectancy less than one month according to the attending physician
- Acute or chronic heart failure (Cardiac ejection fraction \< 40%)
- Pulmonary function - diffusion capacity \< 50% predicted
- Estimated glomerular filtration rate \< 50 ml/min (CKD-EPI)
- Severe neurological disorders
- Patient subject to a legal protection measure (guardianship, curatorship and safeguard of justice) or unable to consent
- Patient deprived of their liberty by a judicial or administrative decision
- Patient with severe psychiatric disorders or hospitalized without consent for psychiatric care
Key Trial Info
Start Date :
December 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04822766
Start Date
December 31 2021
End Date
June 1 2027
Last Update
August 13 2025
Active Locations (1)
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1
Saint Antoine Hospital - Hematology Department
Paris, France, 75012