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.