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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

A Phase I Study of Decitabine in Combination 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Jane Liesveld, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

26037

NCT ID:

NCT00861874

Start Date:

January 2010

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of RochesterRochester, New York  14642