Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT04822766
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
75 Years
Study:
NCT04822766
Study Brief:
Protocol Section:
NCT04822766