Open-label Multicenter Trial to Evaluate the Improvement of Chronic Low-grade Adverse Events Experienced by Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) With Optimal Response to Imatinib When Switched From Imatinib to Nilotinib Treatment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Months
研究概览
简要总结
Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).
详细描述
Study was terminated by Novartis
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nilotinib
Dosage was 300 mg BID daily taken orally without food.
干预措施: Nilotinib (Drug)
结局指标
主要结局
Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Months
时间窗: at 6 month after switching from imatinib to nilotinib
Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to \<2 or from 1 to \<1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.
次要结局
- Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life(Screening, months 1, 3, 6, after switch to nilotinib)
- Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 3 Months(at 3 month after switching from imatinib to nilotinib)
- Number of Participants With Complete Cytogenetic Response (CCyR)(at months 6,12 and 24 after switching from imatinib to nilotinib)
- Number of Participants With a Major Molecular Response(Months 1, 3, 6, early termination)
- Time to and Duration of CCyR and MMR After Switch From Imatinib to Nilotinib at 24 Months(at 24 Months)
- Time to First Improvement of Persistant Chronic Low-grade Non-hematologic AEs at 24 Months After Switch From Imatinib to Nilotinib(first improvement of AEs after switch to 24 Months)