A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome

The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.

Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.

Inclusion Criteria:

• Age≥18;
• The diagnosis of MDS patients comply WHO2008 standards;
• IPSS score≥0.5;
• WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
• ECOG PS score: 0-2;
• Expected survival≥3 months;
• Serum bilirubin≤1.5*ULN, serum ALT and AST≤2.5*ULN, serum Cr≤1.5*ULN;
• Subjects signed informed consent form in line with GCP requirements.

Exclusion Criteria:

• Can not marrow biopsy;
• Previously diagnosed AML;
• Received azacitidine or decitabine treatment any time before;
• Being diagnosed with other malignancies in the prior 12 months;
• Pregnant or lactating women;
• Failure to control systemic fungal, bacterial or viral infection;
• Known or suspected allergy to decitabine;
• Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;
• Have a history of neurological or psychiatric disorders, including epilepsy or dementia;
• CTCAE 3 or 4 degree peripheral neuropathy;
• According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;
• Using other experimental drugs or participating in other clinical trials in the prior one months.