Azacitidine and Sargramostim as Maintenance Therapy in Treating Patients with Poor-Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome That Have Undergone Stem Cell Transplant or Received Cytarabine-Based Chemotherapy

Inclusion Criteria

• Initial diagnosis of poor -risk AML or MDS, treated with either stem cell transplant or cytarabine-based consolidation chemotherapy, within the past 60-185 days; the original diagnosis of AML or MDS must have been confirmed by bone marrow aspirate and/or biopsy review by a Johns Hopkins Hospital (JHH) hematopathologist; poor-risk AML is defined as disease that is therapy-related or arises from a previous marrow disorder, or de novo AML that is associated with any of the following characteristics: patient age 60 years or greater, trilineage dysplasia, disease status greater than or equal to second complete remission (CR2), fms-related tyrosine kinase 3 (FLT3)/internal tandem duplication (ITD) mutations, detectable disease at time of consolidation chemotherapy or SCT, or poor-risk cytogenetics, which include abnormalities of chromosome 3, 5, or 7, trisomy 8, 11q23 abnormalities, t(6;9), 20q-, and complex karyotype
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• No morphologic evidence of leukemia or active MDS as determined by JHH hematopathologist independent review of a bone marrow aspirate and biopsy done following the completion of therapy
• Neutrophil count >= 1000 /uL
• Platelet count >= 50 x 10^9 /uL without platelet transfusions
• Adequate hematocrit independent of red cell transfusions
• No evidence of extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 4 x normal
• Total serum bilirubin < 2 x upper limit normal (unless due to hemolysis, Gilbert’s syndrome, or ineffective erythropoiesis)
• Creatinine =< 2 x upper limit of normal
• Ability to give informed consent
• In agreement to use an effective barrier method of birth control to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile

Exclusion Criteria

• Patients with untreated or uncontrolled infections
• Patients with untreated or uncontrolled grade 3 or 4 graft-versus-host disease (GVHD)
• Pregnancy and lactation
• Concurrent use of any other investigational agents
• Known human immunodeficiency virus (HIV)-positive patients
• Known hypersensitivity to 5AC or GM-CSF