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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT01985061
Eligibility Criteria:
Inclusion Criteria:
1. Patients with poor prognosis myeloid malignancies:
* Myelodysplastic syndrome,
* Acute Myeloid Leukemia (AML) beyond Complete Response (CR1),
* CR1 AML with poor risk cytogenetics
2. Adult patients: aged ≥ 55 years up to 65 or \< 55 years not eligible for myeloablative conditioning regimen based on Total Body Irradiation (TBI) or double alkylating agent combinations.
3. Availability of a HLA identical sibling or matched unrelated donor (10/10)
4. Affiliation to social security
5. Written Informed Consent
Exclusion Criteria:
1. History of previous Allo-Hematological Stem Cell Transplantation (HSCT)
2. HIV positivity
3. Signs of chronic active hepatitis B and/or C
4. Evolutive psychiatric disease
5. Concomitant neoplastic disease
6. Pregnant or lactating woman or without contraception (for child bearing potential wom-en)
7. Usual contra-indications for Allo-HSCT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01985061
Study Brief:
Protocol Section:
NCT01985061