NCT01254188已完成3 期
Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- The Percentage of Patients Achieving MMR by 12 Months
研究概览
简要总结
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
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
- •Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry
排除标准
- •Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
- •Uncontrolled congestive heart failure or hypertension
- •Myocardial infarction or unstable angina pectoris within past 12 months
- •Known T315I mutations
- •QTcF >450 msec
- •Significant arrhythmias
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Nilotinib
Experimental
300 mg BID
干预措施: Nilotinib (Drug)
结局指标
主要结局
The Percentage of Patients Achieving MMR by 12 Months
时间窗: 12 months
MMR is defined as BCR-ABL ratio (%) on IS \<= 0.1% (corresponds to \>=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method
次要结局
- Time to Molecular Response at 24 Months(24 months)
- Duration of Major Molecular Response(3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected)
- Complete Cytogenetic Response(6 months)
- Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.(6,12,18 and 24 months)
- Overall Survival(3, 6, 9, 12, 15, 18, 21, 24 Months)
- Kaplan-Meier Estimates of Progression-free Survival(3,6,9,12,15,18,21,and 24 months)
- Kaplan-Meier Estimates of Failure-free Survival(3,6,9,12,15,18,21,and 24 months)
研究者
研究点 (1)
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