JPRN-UMIN000005903已完成未知
Multicenter Phase II Clinical Study on the Safety and Efficacy of Nilotinib in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Major Molecular Response - Switch to Tasigna Trial (STAT1)
Cooperative study among the East Japan CML Study Group, Shimousa Hematology Study Group, Leukemia Study Group in Mie, Niigata CML Study Group and the NPO Tohoku Hematology Expert Meeting0 个研究点目标入组 120 人开始时间: 2011年7月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
Primary Endpoint CMR rate at 24 M was estimated at 44.6% (90%CI 34.7-54.8%). Secondary Endpoints CMR rate at 12 M was estimated at 27.0%(90%CI 18.7-36.3%). Sustained CMR rate at 24 M was estimated at 20.3%(95%CI 11.1-29.4%).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients previously treated by tyrosine kinase inhibitors other than imatinib. 2) Patients who are participating in any other clinical trial. 3) Patients with the T315I point mutation of BCR-ABL. 4) Patients with one of the following indicators of cardiovascular dysfunction. i) The QT interval cannot be measured on the ECG ii) Complete left bundle branch block iii) Ventricular pacemaker iv) Congenital QT interval prolongation syndrome or a family history of QT interval prolongation syndrome v) History of or current severe ventricular or atrial tachycardia vi) Clinically significant bradycardia at rest (<50 bpm) vii) History of clinically diagnosed myocardial infarction viii) History of unstable angina within 12 months prior to initiation of the study ix) Other clinically significant cardiovascular complications 5) Patients with another primary malignant tumor. 6) Gastrointestinal dysfunction or diseases that could greatly influence absorption of the study medication. 7) Patients with a history of acute or chronic pancreatitis within 1 year prior to participation to the study. 8) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period. 9) Patients with multiple invasive cancers within 5 years prior to initiation of the study. 10) Patients with other serious or uncontrollable complications. 11) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. 12) Patients with cognitive dysfunction. 13) Other patients whom the investigator considers to be unsuitable for participation in the study.
研究者
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