NCT02314273已完成4 期
Effect of Treatment Using rhIL-11 in Patients With Thrombocytopenia After Chemotherapy for Childhood Acute Lymphoblastic Leukemia
Shanghai Children's Medical Center5 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- platelet infusion
研究概览
简要总结
The goal of this clinical research study is to find out if rhIL-11（Interleukin 11） may increase the platelet count in Childhood patients with acute lymphocytic leukemia (ALL) who develop low platelet counts while receiving standard CAT（cyclophosphamide+Cytosine arabinoside+mercaptopurine，7d） therapy.
详细描述
Group A：patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL Group B：control group
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •new diagnosis of ALL
- •TBIL≤34umol/L，Cr≤120umol/L，a normal EF
- •age <18 years
排除标准
- •patients with uncontrolled infection
- •patients with Acute congestive heart failure or chronicity cardiorespiratory functional defect or serious cardiac arrhythmias
研究组 & 干预措施
rhIL-11 group
Experimental
patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80,000/mL
干预措施: rhIL-11 (Drug)
结局指标
主要结局
platelet infusion
时间窗: 14 days
frequency of platelet infusion
次要结局
- platelet Count(14 days)
- remission rate(14 days)
- hemorrhagic tendency(14 days)
- infection(14 days)
研究者
研究点 (5)
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