Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia

Untreated AML patients (defined by WHO 2008 criteria) over the age of 60 or relapsed/refractory AML over the age of 18 who have received up to 2 previous lines of intensive chemotherapy * No prior failure to achieve at least a PR with Azacitidine or Everolimus * Provision of written informed consent * Secondary AML (including therapy-related) are included * Life expectancy of greater than 3 months in relation to diseases other then AML/MDS * ECOG performance status 0 - 3 * Electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements * Adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN * Adequate renal function, with serum creatinine ≤ 1.5 x ULN or GFR \> 30 ml/minute * Patients with no uncontrolled active infection * Hydroxyurea ceased 48 hours prior to study therapy Exclusion Criteria * Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study * History of major non-compliance to medication * Evidence of CNS leukemia * Uncontrolled viral infection with known HIV or Hepatitis type B or C * Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication * Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol * Males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose