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

The primary objective of this study is to:

• To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine
(HiDAC) for AML consolidation administered in an outpatient setting.

The secondary objectives of this study are to:

- To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of
care inpatient HiDAC consolidation.

- Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to
that with the standard inpatient regimen.

Inclusion Criteria:

Inclusion Criteria for Outpatient Administration of HiDAC

- Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO
classification), excluding M3 (acute promyelocytic leukemia).

- Documented complete remission (CR) following induction chemotherapy as defined as
(18):

- Bone marrow with <5% blasts; absence of blasts with Auer rods

- Absolute neutrophil count >1000/mcL

- Platelets >100,000/mcL

- Independence of red cell transfusions

- Absence of extramedullary disease

- Age ≥ 55 years.

- Relapsed AML patients are eligible as long as they meet other inclusion and 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).

Inclusion Criteria for Quality of Life Comparison Group

- All patients decline to participate as an out-patient or who are not eligible for
participation in the out-patient portion of the study will be approached to
participate in the QOL comparison.

- Age ≥ 18 years

Exclusion Criteria:

Exclusion Criteria for All Patients

- 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.