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Complete title: Idarubicin, Cytarabine and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)
|Research Study Number||2674.00|
|Principal Investigator||Raya Mawad|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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, 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
- Previous data reports a < 2% incidence of clinical cardiotoxicity with idarubicin even at cumulative doses >= 175mg/m^2 in patients who have never received anthracyclines; since idarubicin associated cardiotoxicity rarely occurs until cumulative doses are much higher than those proposed in this trial, we will not exclude patients base 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
Other eligibility criteria may apply.
Hematologic Malignancies; Leukemia; Lymphoma; Non-Hodgkin's Lymphoma (NHL); Mycosis Fungoides/Sezary Syndrome
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