A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria:

- Age greater than or equal to 18 years

- Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND

- Refractory AML defined as a failure to achieve CR after 2 cycles of induction
chemotherapy or persistence of > 40% bone marrow blasts after one cycle of
chemotherapy induction OR

- Relapsed AML defined as any evidence of disease recurrence within 12 months of
achieving first CR OR

- Relapsed AML after stem cell transplantation 100 days must have elapsed between
transplant and emergence of recurrent AML

- ECOG performance status <3 (Appendix 1)

Exclusion Criteria:

- Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min
(Cockcroft-Gault formula (Appendix 2)

- Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper
limits of normal

- Active systemic infection

- Known chronic liver disease

- Known diagnosis of human immunodeficiency virus infection (HIV)

- Patients who are post-allogeneic transplantation should not have active GVHD
greater than grade 1 of skin

- Pregnant or breast feeding female subjects