A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

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

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

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

Conditions
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Myelodysplastic Syndrome

Intervention / Treatment
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* Drug: Decitabine Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Ⅰ<br>Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks. | Drug: Decitabine Injection<br>* Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.<br>* Other names: qingweike;|
| Experimental: Arm Ⅱ<br>Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks. | Drug: Decitabine Injection<br>* Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.<br>* Other names: qingweike;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome. | The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al. | 2-4 months |