Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

I. To determine rates of complete remission (CR), remission with incomplete blood count
recovery (CRi), partial remission (PR), relapse-free survival and overall survival.

II. To identify biomarkers (ie. changes in serum cholesterol) associated with clinical
responses.

OUTLINE:

Patients receive pravastatin sodium orally (PO) once daily (QD) 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.

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World
Health Organization (WHO) 2008 criteria, including patients with >= 20% blasts in the
bone marrow or peripheral blood (except acute promyelocytic leukemia), or
myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO
classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone
marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) CMML-2 by
WHO 2008 classification

- Untreated AML or high-risk myelodysplastic syndrome (MDS) and a simplified TRM score
of =< 9.2

- Bilirubin < 2.0 mg/ml

- Any creatinine value is acceptable

- Any performance status is eligible

- Life expectancy otherwise > 1 year

- Patients are not excluded based on cardiac history

- Females of childbearing potential must have a negative serum pregnancy test within 2
weeks prior to enrollment

- Patients must use an effective contraceptive method during the study and for a minimum
of 90 days after study treatment

- Capable of understanding the investigational nature, potential risks and benefits of
the study, and able to provide valid informed consent