NCT02013102
Unknown
4 期
A Randomized, Controlled, Multi-center Collaborative Phase Ⅳ Study to Evaluate the Safety and Efficacy of Decitabine in Myelodysplastic Syndrome
Cttq1 个研究点 分布在 1 个国家目标入组 240 人2013年3月
概览
- 阶段
- 4 期
- 干预措施
- Decitabine Injection
- 疾病 / 适应症
- Myelodysplastic Syndrome
- 发起方
- Cttq
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
- 最后更新
- 12年前
概览
简要总结
The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
详细描述
Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.
研究者
入排标准
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Arm Ⅰ
Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks.
干预措施: Decitabine Injection
Arm Ⅱ
Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.
干预措施: Decitabine Injection
结局指标
主要结局
The safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
时间窗: 2-4 months
The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR，mCR，PR，HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.
研究点 (1)
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