Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Exclusion Criteria

• •Good performance status of (ECOG 0-2), see appendix 15.3.
• •Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase \<3.0 x upper limit of normal, total bilirubin \<1.5 x upper limit of normal unless there is a history of Gilbert's disease).
• •Age ≥ 18 years
• •Active, uncontrolled viral, bacterial, or fungal infection.
• •Documented CNS leukemia.
• •If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
• •History of prior autologous or allogeneic bone marrow/stem cell transplant.
• •New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
• •Pregnant or lactating women (women and men of childbearing age should use effective contraception).
• •Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
• •Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
• •Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.