Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse

Inclusion Criteria:

Patients who have undergone T cell depleted allogeneic hematopoietic stem cell
transplantation at MSKCC for:

- De novo myelodysplastic syndromes (MDS): IPSS-1 with poor risk cytogenetics or higher
IPSS.

- Acute myelogenous leukemia (AML) in first remission that required more than 1 cycle of
treatment to achieve remission or with the following cytogenetic abnormalities: FLT3
mutation, deletion/monosomy of chromosome 5 or 7, MLL gene rearrangement, or more than
or equal to 3 cytogenetics abnormalities. Also patients in second or greater
remission.

- Patients with Secondary MDS/AML.

- Patients will be considered eligible for the study if after transplant they achieved
hematologic (<5% blasts) and cytogenetic remission.

- Patients will be eligible to enter the study between 60-120 days post transplant.

- Age: pediatrics and adults patients - 1 year old-75 years old.

- Karnofsky performance status >=60% for patients >16yo and Lansky performance status
>=60% for patients ≤16yo

- Stable blood counts (ANC>1000/uL, Hb>8gr/dL, Plt>50,000/ uL) not supported by
transfusions.

- Renal: Serum creatinine <1.5 ULN

- Hepatic: <3xULN ALT and <1.5 total serum bilirubin, unless there is congenital benign
hyperbilirubinemia.

- Cardiac: Adequate cardiac function measured by LVEF>50%. If asymptomatic,
pretransplant echocardiogram is adequate. If symptomatic, echocardiogram needs to be
repeated.

- Each patient must be willing to participate as a research subject and must sign an
informed consent form.

Exclusion Criteria:

Patients will be excluded from the trial if at time of enrollment:

- Active uncontrolled bacterial, fungal or viral infection.

- Evidence of uncontrolled graft-versus-host disease.

- Pulmonary: new onset hypoxia

- Known or suspected hypersensitivity to 5'-azacitadine or mannitol.

- Evidence of residual disease either by increased blasts count (>5%) or
persistence of previous known cytogenetics abnormalities.

- Peripheral blood neutrophil chimerism: less than 95% donor.