NCT00237120已完成3 期
Efficacy, Safety and Long-term Prognosis of Imatinib in Patients Newly Diagnosed With Chronic Myelogenous Leukemia (Chronic Phase)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 100
- 主要终点
- 3 years overall survival
研究概览
简要总结
This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
- •Previously untreated with Interferon-alpha
- •Performance status is normal or capable of only limited self-care
排除标准
- •Patients who are pregnant or possibly pregnant
- •Significant hepatic diseases
- •Chronic Myelogenous Leukemia in advanced phase
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
3 years overall survival
Duration of remaining in chronic phase
次要结局
- Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,
- Adverse event
研究者
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