Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

Inclusion Criteria

• Patients with a diagnosis of AML (World Health Organization classification: >=20% blasts in the bone marrow and / or peripheral blood) or MDS (International Prognostic Scoring System intermediate-1 or higher) that at the time of allogeneic transplantation were in: - Induction Failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. Patients with de novo or therapy-related MDS, CMML, or AML are also eligible, regardless of cytogenetics or molecular rearrangements.
• Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
• Patients must be in complete remission post transplant.
• Patient may be enrolled 40 to 100 days after transplant.
• Age 18 to 75 years old.
• Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation*. a. Males(mL/min):(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)) b. Females(mL/min):0.85*(140-age)*IBW(kg) / 72*(serum creatinine(mg/dl)).
• Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).
• SGPT </= 200 IU/ml unless related to patient's malignancy.
• Be able to understand and sign informed consent.

Exclusion Criteria

• Active uncontrolled infection.
• Presence of uncontrolled graft-versus-host disease.
• Patients that underwent allogeneic transplantation as a treatment of graft failure.
• Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
• Known or suspected hypersensitivity to azacitidine or mannitol.
• Patients with advanced malignant hepatic tumors.