NCT00171860终止2 期
A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate of complete and partial response and relapse
研究概览
简要总结
The objectives of the study are:
- Evaluation of the safety profile of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome resistant or refractory to, or intolerant of, prednisone, hydroxyurea or interferon-alpha, or untreated patients carrying the Fip1L1-PDGFRA fusion protein.
- Evaluation of the efficacy of imatinib mesylate in patients with idiopathic hypereosinophilic syndrome
- Analysis of patient's blood samples for the detection of activated kinases.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic hypereosinophilic syndromes are included provided they belong to one of the following categories:
- •previously treated and showing documented resistance or refractoriness to, or intolerance of, prednisone, hydroxyurea or interferon-alpha.
- •not previously treated but with documented Fip1L1-PDGFRA fusion protein
排除标准
- •Other diseases associated with hypereosinophilia
- •Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
- •ECOG performance status >3
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
STI571
Experimental
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Rate of complete and partial response and relapse
次要结局
- Bone Marrow Analysis
- Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
- Disease-Related Symptoms and Signs
- Organ Involvement
研究者
研究点 (1)
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