Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)

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