A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Platelet count
研究概览
简要总结
Decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of decitabine in the treatment of ITP.
详细描述
The investigators are undertaking a multicenter, single-arm study of primary ITP adult patients from 9 medical centers in China. All the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days per cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines
- •failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye
- •baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms
- •need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or
排除标准
- •secondary ITP
- •pregnancy
- •hypertension
- •cardiovascular disease
- •liver and kidney function impairment
- •HCV, HIV, HBsAg seropositive status
- •patients with systemic lupus erythematosus and/or antiphospholipid syndrome
研究组 & 干预措施
Decitabine
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
干预措施: Decitabine (Drug)
结局指标
主要结局
Platelet count
时间窗: the third month after the first dose of decitabine
plate level at the third month after the first dose of decitabine
次要结局
- Bleeding score(at enrollment and the third month after the first dose of decitabine)
研究者
Ming Hou
Professor and Director
Shandong University