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

This study has been completed.
Information provided by (Responsible Party):
Jane Liesveld, University of Rochester Identifier:
First received: March 12, 2009
Last updated: October 8, 2012
Last verified: October 2012
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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: Decitabine Drug: Rapamycin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Resource links provided by NLM:

Further study details as provided by Jane Liesveld, University of Rochester:

Primary Outcome Measures:
  • Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine. [ Time Frame: 6 months ]

Enrollment: 13
Study Start Date: January 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Decitabine
20 mg/m2 IV, Days 1-5
Drug: Rapamycin
Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00861874

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Jane Liesveld, MD University of Rochester
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jane Liesveld, Professor of Medicine, Hematology and Bone Marrow Transplant, University of Rochester Identifier: NCT00861874     History of Changes
Other Study ID Numbers: 26037
Study First Received: March 12, 2009
Last Updated: October 8, 2012

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017