Idarubicin, Cytarabine, and Pravastatin Sodium in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes
Condition: Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Refractory Anemia With Excess Blasts; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Leukemia, Monocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Myelodysplastic Syndromes; Myeloproliferative Disorders; Anemia, Refractory; Myelodysplastic-Myeloproliferative Diseases; Anemia, Refractory, with Excess of Blasts; Syndrome
Study type: Interventional

Summary: 
      This clinical trial studies idarubicin, cytarabine, and pravastatin sodium in treating
      patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndromes. Drugs used
      in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth
      of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin
      sodium may stop the growth of cancer cells by blocking some of the enzymes needed for cell
      growth. Giving idarubicin and cytarabine together with pravastatin sodium may kill more
      cancer cells.
    

Detailed description: 
      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.
    

Intervention name(s): pravastatin sodium; idarubicin; cytarabine; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Given PO; Given IV; Given IV; Correlative studies
Other intervention name(s): PRAV; Pravachol; 4-demethoxydaunorubicin; 4-DMDR; DMDR; IDA; ARA-C; arabinofuranosylcytosine; arabinosylcytosine; Cytosar-U; cytosine arabinoside
Intervention MeSH terms: Cytarabine; Idarubicin; Pravastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment