A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care

Inclusion Criteria:

• Have a diagnosis of refractory anemia with excess blasts or refractory anemia withexcess blasts in transformation according to the French-American-Britishclassification system for myelodysplastic syndromes (MDS) and a relatively high riskof acute myeloid leukemia (AML) transformation, with an International PrognosticScoring System score of INT-2 or High.

• Be 18 years of age or older

• Have a life expectancy of at least 3 months

• Be unlikely to proceed to bone marrow or stem cell transplantation therapy followingremission

• Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normalrange for the laboratory

• Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serumglutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 times the upper limit of normal (unless these are considered to be related totransfusion-induced secondary hemosiderosis)

• Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal

Exclusion Criteria:

• Secondary myelodysplastic syndromes (MDS)

• Prior treatment with azacitidine;

• Prior history of acute myeloid leukemia (AML);

• Malignant disease diagnosed within prior 12 months;

• Metastatic disease;

• Hepatic tumors;

• Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12months;

• Prior transplantation or cytotoxic therapy to treat MDS;

• Serious medical illness likely to limit survival to 12 months or less;

• Treatment with erythropoietin or myeloid growth factors during prior 21 days orandrogenic hormones during prior 13 days;

• Active HIV, viral hepatitis type B or C;

• Treatment with investigational drugs during prior 30 days;

• Within the 28-day screening period, documented red cell folate deficiency, asevidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency