Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)
I. To assess the rate of achieving a "good complete response (CR)" after treating patients
with newly diagnosed acute myeloid leukemia (AML) with idarubicin, cytarabine and
pravastatin (pravastatin sodium) (IAP).
II. To determine the toxicity (death within 28 days of starting therapy = treatment related
mortality or "TRM") with IAP in newly-diagnosed AML.
I. To determine rates of complete remission (CR), remission with incomplete blood could
recovery (CRi), partial remission (PR), relapse-free survival and overall survival.
II. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical
Patients receive pravastatin sodium orally (PO) four times daily (QID) on days 1-8,
idarubicin intravenously (IV) over 10-15 minutes on days 4-6, and cytarabine IV continuously
on days 4-7. Treatment repeats every 28-56 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
and then annually for 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with good CR
A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.
Up to 5 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|