Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

PRIMARY OBJECTIVES:

I. Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or
advanced myelodysplastic syndrome (MDS) by examining whether > 50% of patients treated as
outpatients can complete chemotherapy without being admitted to hospital or < 5% of patients
die within 14 days of beginning outpatient chemotherapy.

OUTLINE:

Patients receive outpatient induction chemotherapy.

Inclusion Criteria:

- Signed written informed consent

- The signed informed consent

- The benefits/risks of the induction chemotherapy regimen will be reviewed, and a
second consent may be necessary if the regimen will be administered according to
a separate protocol

- AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in
marrow by morphology or flow cytometry or blood)

- Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when
chemotherapy of similar intensity as proposed here is administered to inpatients

- Blast count =< 10,000

- Fibrinogen > 200

- Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal
infection unless determined to be, at the discretion of the investigator, not
clinically significant in the context of this study

- Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF)
of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing
cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart
failure

- Patient must have an outpatient caregiver available

- Patient must live within 30 minutes of the treating physician's office during
outpatient treatment

- Patient must be willing to return to the treating physician's office for outpatient
follow-up once outpatient treatment is completed

- Logistical requirements:

- Space available in infusion room

- Outpatient infusion pump available if continuous infusion required

- Case discussed with infusion room nursing staff