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.