A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome

Inclusion Criteria

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 SGPT
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.