A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

Inclusion Criteria:

Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])
Age ≥ 60 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:

t(8;21)(q22;q22)
inv(16)(p13;q22 or t(16;16)(p13;q22)
t(15;17)(q22;q12) and variants.
Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%

Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia
Prior treatment with clofarabine
Prior treatment for AML or an antecedent hematologic disorder
Prior hematopoietic stem cell transplant (HSCT)
Prior radiation therapy to the pelvis
Investigational agent received within 30 days prior to the first dose of study drug
Ongoing uncontrolled systemic infection
Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Clinical evidence of central nervous system (CNS) involvement
Severe concurrent medical condition or psychiatric disorder that would preclude study participation
Positive human immunodeficiency virus (HIV) test