Status:
COMPLETED
A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
University of Rochester
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00861874
Start Date
January 1 2010
Last Update
October 10 2012
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642