Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

Inclusion:

• MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization

• 18 years or older

• Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding

• ECOG or WHO performance status of 0-2

• Written informed consent

• Normal renal and hepatic function (creatinine </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)

Exclusion:

• Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive malignant disease

• Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)

• Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.

• Administration of any investigational agent within the 30 days preceding study initiation.

• Uncontrolled cardiac disease or congestive heart failure

• Uncontrolled restrictive or obstructive pulmonary disease

• Active viral or bacterial infection

• Superimposed autoimmune hemolytic anemia or thrombocytopenia

• Known positive serology for HIV

• Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.