NCT00809211已完成2 期
A Phase II Multi-center, Open-label, Study of Nilotinib at a Dose of 300mg Twice Daily in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Complete cytogenetic response rate at 6 months as assessed by metaphase analysis
研究概览
简要总结
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with newly diagnosed chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
Primary
- To establish the complete cytogenetic response rate at 6 months in patients with newly diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with nilotinib.
Secondary
- To establish the complete cytogenetic response rate at 3, 9, 12, 18, and 24 months in these patients.
- To establish the molecular response rate at 3, 6, 9, 12, 18, and 24 months in these patients.
- To establish the safety of this drug in these patients.
- To correlate pharmacokinetic data with response rate and toxicity.
- To correlate Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR.
- To estimate the prevalence of Bcr-Abl mutations prior to and during treatment.
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
- 18 Years 至 120 Years（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
Experimental
干预措施: nilotinib (Drug)
Nilotinib
Experimental
干预措施: cytogenetic analysis (Genetic)
Nilotinib
Experimental
干预措施: mutation analysis (Genetic)
Nilotinib
Experimental
干预措施: polymerase chain reaction (Genetic)
Nilotinib
Experimental
干预措施: pharmacological study (Other)
结局指标
主要结局
Complete cytogenetic response rate at 6 months as assessed by metaphase analysis
时间窗: 6 months
次要结局
- Molecular response rate at 3, 6, 9, 12, 18, and 24 months as assessed by quantitative PCR(6 months)
- Time to disease progression(6 months)
- Overall toxicity rate(6 months)
- Correlation of pharmacokinetic data with response rate and toxicity(6 months)
- Correlation of Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR(6 months)
- Duration of event-free survival(6 months)
- Prevalence of Bcr-Abl mutations prior to and during treatment(6 months)
研究者
研究点 (6)
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