Low Dose Azacitidine after Transplant in Preventing Recurrence in Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia in Remission

Inclusion Criteria

• Patients who have undergone T-cell depleted allogeneic hematopoietic stem cell transplantation at Memorial Sloan-Kettering Cancer Center (MSKCC) for:
• De novo myelodysplastic syndromes (MDS): International Prognostic Scoring System intermediate-1 (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
• Karnofsky performance status >= 60% for patients > 16 years old (yo) and Lansky performance status >= 60% for patients =< 16 yo
• Absolute neutrophil count (ANC) > 1000/uL not supported by transfusions
• Hemoglobin (Hb) > 8 gr/dL not supported by transfusions
• Platelets > 50,000/uL not supported by transfusions
• Serum creatinine < 1.5 upper limit of normal (ULN)
• < 3 x ULN alanine aminotransferase (ALT), unless there is congenital benign hyperbilirubinemia
• < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia
• Adequate cardiac function measured by left ventricular ejection fraction (LVEF) > 50%; if asymptomatic, pre-transplant 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
• Patients who were treated with 5'-azacitidine without response prior to transplant would be eligible to participate on this protocol

Exclusion Criteria

• Active uncontrolled bacteria, fungal or viral infection
• Evidence of uncontrolled graft-versus-host disease
• Pulmonary: new onset hypoxia
• Known or suspected hypersensitivity to 5'-azacitidine 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