Last updated on July 2012

Clofarabine Cytarabine and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Leukemia | Myelodysplastic Syndromes
  • Age: Between 18 - 60 Years
  • Gender: Male or Female
  • Other:
    Diagnosis of 1 of the following by WHO criteria:
    Acute myeloid leukemia (AML) (≥ 20% bone marrow blasts by bone marrow aspiration
    or biopsy)
    No acute promyelocytic leukemia (M3)
    All cytogenetic groups allowed, except for the following:
    t(8;21) or inv(16) AND a WBC count at diagnosis of < 100,000/μL
    Primary or secondary AML allowed, including AML after myelodysplasia (MDS)
    High-risk MDS (≥ 10% bone marrow blasts by bone marrow aspiration or biopsy)
    No chronic myelogenous leukemia in blast crisis or AML supervening a
    myeloproliferative disorder
    Previously untreated disease, except for ≤ 14 days of hydroxyurea
    No CNS leukemia
    WHO performance status 0-2
    Serum creatinine ≤ 1.0 mg/dL or glomerular filtration rate > 60 mL/min
    AST/ALT ≤ 2.5 times upper limit of normal (ULN)
    ALP ≤ 2.5 times ULN
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective barrier contraception during and for ≥ 3 months
    after completion of study treatment
    No active uncontrolled infection
    No HIV positivity
    No psychological, familial, sociological, or geographical conditions precluding
    compliance with study treatment or follow up
    No concurrent severe uncontrolled cardiovascular disease (i.e., symptomatic
    congestive heart failure or symptomatic ischemic heart disease [NYHA class III-IV])
    No concurrent malignant disease
    See Disease Characteristics
    No concurrent cytotoxic drugs or experimental therapies (e.g., antiangiogenic drugs,
    tyrosine kinase inhibitors)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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