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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01301820
Eligibility Criteria:
Inclusion Criteria:
* Cytologically or histologically confirmed acute myeloid leukemia (AML) with :
* At least 60 years of age and fit for intensive chemotherapy: PS \<2 (ECOG)
* Absence of significant co-morbidities
* Less than 75 years\* of age
* LAM with high risk features (blasts \> 20% in bone marrow)
* Poor risk cytogenetics
* Life expectancy \> 1 month
* Affiliated to social security regimen
* No granulocytic sarcoma as sole site of disease
* Able and willing to provide written and signed informed consent
Exclusion Criteria:
* Total bilirubin \> 2 times upper limit of normal
* AST and ALT and/or alkaline phosphatase \> 4 times upper limit of normal if not in relation with AML.
* Factor V \< 50% without DIC (Disseminated Intravascular Coagulation)
* NYHA class III or IV congestive heart failure (Echo \< 40%, LVEF \< 50%),Unstable angina pectoris, Serious cardiac arrhythmia
* Renal failure not related to AML: serum creatinin \> 170 μmol/L or clearance of creatinin ≤ 50 mL/mn
* Known HIV 1- HIV 2 positivity
* Prior therapy with azacitidine or lenalidomide
* Psychiatric illness or social situations that would preclude compliance with study requirements
* Uncontrolled infection
* Urgent chemotherapy for DIC, spontaneous tumoral lyse syndrome, leucostase without cytogentic results
* Women who are pregnant or breastfeeding
* Women who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy
* Men who are unwilling or unable to use an acceptable method of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT01301820
Study Brief:
Protocol Section:
NCT01301820