IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML) (AML)

Inclusion Criteria:

• Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:

  • Primary refractory disease following ≥ 1 round of induction chemotherapy
  • First relapse or higher
• Age between 18 and 70 years
• ECOG performance status ≤ 2

• Adequate organ function defined as:

  • Creatinine ≤ 1.5 x institutional ULN
  • AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  • ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  • Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
  • Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
• Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
• Able to provide signed informed consent prior to registration on study

Exclusion Criteria:

• Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
• Peripheral blood blast count ≥ 50 x 103 /mm3
• Active CNS involvement with leukemia
• Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
• Pregnant or nursing
• Concurrently receiving any other investigational agent
• Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
• Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
• Severe concurrent illness that would limit compliance with study requirements