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A Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia - NCT00861874-14642(Clinical Trial 278300)



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City:  Rochester
State:  
NY
Zip Code: 14642
Conditions: Acute Myeloid Leukemia
Purpose: 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.
Study summary:
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
Study is available at: University of Rochester
Rochester, NY 14642
United States

Primary Contact:
Jane Liesveld, MD
Email: Jane_Liesveld@urmc.rochester.edu
Phone: 585-275-4099

Secondary Contact:
Jane Liesveld, MD
Email: Jane_Liesveld@urmc.rochester.edu
Phone: 585-275-4099
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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