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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03796533
Eligibility Criteria:
Inclusion Criteria:
1. Patient aged 18 or over
2. Patients with AML de novo or secondary to myelodysplastic syndrome or therapy-related AML except acute myeloid leukemia (AML3)
3. Patient hospitalized for the treatment of leukemia (induction chemotherapy or consolidation)
4. General state retained (ECOG performance scale ≤ 3)
5. alanine aminotransferase aspartate transaminase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 2 times the ULN, creatinine \<150 μmol / L unless these biological abnormalities are related to leukemia
6. Patients affiliated or beneficiaries of a social security scheme (Social Security or Universal Medical Coverage)
7. Having read and understood the information sheet and signed the informed consent
Exclusion Criteria:
1. Patients with acute promyelocytic leukemia (AML3)
2. History of uncontrolled cancer for at least two years
3. Patient included in another clinical study that may interfere with the objectives of this study
4. Treatment with antifungal other than posaconazole
5. Severe uncontrolled infection at the time of inclusion
6. Positive serology for HIV 1 or 2 or human T-cell lymphoma virus (HTLV 1) or 2, or active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
7. Pregnant woman (beta positive HCG) or breastfeeding
8. A woman of childbearing potential who can not justify the use of effective contraception during treatment with Noxafil®
9. Patient incapacitated, under guardianship, curators or safeguard of justice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03796533
Study Brief:
Protocol Section:
NCT03796533