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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Azacitidine; Decitabine; Everolimus; Sirolimus

Criteria

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