Study of Plerixafor Combined With Cytarabine and Daunorubicin in Patients With Newly Diagnosed Acute Myeloid Leukemia

Exclusion Criteria

• •Have received previous systemic treatment for leukemia or antecedent hematologic disorder (AHD), other than hydroxyurea or hematopoietic growth factors. Treatment with hydroxyurea within 2 weeks of screening is allowed but must be discontinued at least 24 hours prior to the first dose of study drugs.
• •Have received prior treatment with plerixafor, cytarabine, or any anthracycline.
• •Have a diagnosis of acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 or World Health Organization (WHO) classification of APL with t(15;17)(q(22;q12), or Bcr-Abl positive leukemia.
• •For patients \< 50 years of age, have cytogenetics associated with good prognosis \[(t(8;21)q(22;22), t(15;17),inv(16)(p13;q22)\]. (Testing for these mutations must be performed on blood or Bone Marrow prior to study registration.
• •Have had a hematopoietic stem cell transplant (HSCT).
• •Have an absolute blast count of the following at the time of first dose of chemotherapy, despite cytoreduction with hydroxyurea or leukapheresis:
• •1. \>50 x 10\^9/L for patients not enrolled in a G-CSF-containing cohort
• •2. \>25 x 10\^9/L for patients enrolled in a G-CSF-containing cohort
• •Have central nervous system (CNS) leukemia (Only patients with suspected CNS leukemia must undergo lumbar puncture.)
• •Have any of the following within the last 12 months: unstable supraventricular arrhythmia (e.g., hemodynamic instability) or has a pacemaker; Any ventricular arrhythmia, other than occasional premature ventricular contractions; Congestive heart failure (controlled or uncontrolled); Myocardial infarction, ischemia, stable coronary artery disease, or angina; Uncontrolled hypertension; Syncope with either a known cardiovascular or an unknown etiology.
• •Have a pre-existing disorder predisposing the patient to serious or life-threatening infection (e.g., cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias).
• •Have the need for anticoagulant therapy.
• •Have a significant medical or psychiatric disorder that would interfere with consent, study participation, or follow-up.
• •Have an active acute or chronic systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection \[except isolated fever\] and without improvement, despite appropriate antibiotics or other treatment).
• •Have severe concurrent diseases (e.g., a history of serious organ dysfunction or disease) that may place the patient at undue risk to undergo induction therapy per protocol, or obscure assessments of drug safety.
• •Have a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent, with the following exceptions:
• •1. Patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or
• •2. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values after treatment with curative intent.
• •Have known human immunodeficiency virus (HIV) positivity or evidence of active viral hepatitis.
• •Are pregnant or breastfeeding.
• •Are known to have an allergy to any component of the study drug regimen