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OpenTrials
Completed

NCT Number: NCT00861874

A 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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decitabine

Drug

20 mg/m2 IV, Days 1-5

Rapamycin

Drug

Dose level 1 = 2mg/daily, Dose level 2 = 4mg/daily, Dose level 3 = 6mg/daily. Oral, Days 6-26

Primary outcomes

  1. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
First posted
Mar 16, 2009
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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