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

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

The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose 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