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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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)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy278300.aspx

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City:

Rochester

State:

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

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:

November 16, 2009

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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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