NCT01279473已完成1 期
A Phase I/II Multicenter, Dose-escalation Study of Oral Nilotinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ALL (Philadelphia Positive Acute Lymphocytic Leukemia)(Extension Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who complete CAMN107A1101 and obtained Informed concent by document
排除标准
- 未提供
研究组 & 干预措施
Nilotinib
Experimental
干预措施: Nilotinib (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: 3 weeks
次要结局
- Best hematologic response rate and Best cytogenetic response rate.(3 years)
- Percentage of BCR-ABL genes transcript and mutation status of BCR-ABL(3 years)
研究者
研究点 (1)
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