|Closed||Acute Myeloid Leukemia||Phase II||
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.
- Histologically or cytologically confirmed diagnosis of acute myeloid leukemia by World Health Organization (WHO) 2008 criteria (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, since this value is incorporated in the TRM and an elevated creatinine is not an issue with idarubicin or cytarabine on a continuous infusion schedule
- Any performance status is eligible, since it is also incorporated in the TRM score
- Life expectancy otherwise > 1 year
- Patients will not be 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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