A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cttq
• Treatments: Azacitidine; Decitabine

Criteria

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.