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

University of Rochester

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Decitabine

Drug: Rapamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00861874

26037

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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