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



Status:Recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2010
Contact:Jane Liesveld, MD
Email:Jane_Liesveld@urmc.rochester.edu
Phone:585-275-4099

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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
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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