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 人开始时间: 2013年3月最近更新:
概览
- 阶段
- 4 期
- 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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Experimental
Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks.
干预措施: Decitabine Injection (Drug)
Arm Ⅱ
Experimental
Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.
干预措施: Decitabine Injection (Drug)
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.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromeNCT01751867Xian-Janssen Pharmaceutical Ltd.135
Unknown
3 期
Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid LeukemiaAcute Myeloid Leukemia, AdultNCT02985372Chunyan Ji30
已完成
不适用
A Study for Dacogen Treatment in Patients With Myelodysplastic SyndromeMyelodysplastic SyndromeNCT01041846Janssen Korea, Ltd., Korea103
终止
1 期
Phase I/II: Decitabine/Vaccine Therapy in Relapsed/Refractory Pediatric High Grade Gliomas/Medulloblastomas/CNS PNETsGliomasMedulloblastomaNeuroectodermal Tumors, PrimitiveNCT02332889University of Louisville1
已完成
3 期
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)Diabetes Mellitus, Type 2NCT00094757Merck Sharp & Dohme LLC521