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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT00861874
Run by: University of Rochester
People needed: 13
Starts: 2010-01-01
Last updated by the study team: 2012-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.