A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)

Inclusion Criteria

Inclusion Criteria

Subjects who meet all of the following criteria may be included in the study:

1. Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1
transfusion dependent, Intermediate-2, or High-risk [defined by International
Prognostic Scoring System (IPSS) score of ≥0.5] and recognized
French-American-British (FAB) classifications

2. Male or female, 18 years of age or older with signed informed consent

3. Adequate renal function

4. Demonstrated normal liver function

5. Female subjects of childbearing age must have negative pregnancy test within 1 week
of study entry and agree to use adequate contraception for the duration of the trial
and for a minimum of six months after last dose of decitabine or azacitidine
received.

6. Male subjects must agree to use adequate contraception for the duration of the trial
and for a minimum of six months after last dose of decitabine or azacitidine
received.

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in the
study:

1. Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering
study (permitted if > 2 weeks from study entry and if recovered from toxic effects of
therapy)

2. Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing
signs or symptoms of infection and without improvement despite appropriate treatment)

3. Pregnancy or current lactation

4. Significant concurrent disease, illness, or psychiatric disorder

5. Treatment with an investigational agent 30 days prior to the first dose of decitabine
or azacitidine