NCT00769327已完成2 期
Front-line Treatment of Philadelphia Positive (Ph Pos), BCRABL Positive, Chronic Myeloid Leukemia (CML) With Two Tyrosine Kinase Inhibitors (TKI) (Nilotinib and Imotinib) A Phase II Exploratory Multicentric Centre.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 50
- 主要终点
- Complete cytogenetic response rate
研究概览
简要总结
RATIONALE: Nilotinib and imatinib mesylate 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 giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
Primary
- To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia treated with nilotinib and imatinib mesylate.
Secondary
- To assess the complete cytogenetic response rate at 6 and 24 months in these patients.
- To assess the major and complete molecular response rate at 6, 12, and 24 months in these patients.
- To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during and for 3 years after study treatment.
- To assess the rate of failures and the time to failure at 12, 24, and 60 months in these patients.
- To assess compliance, toxicity, and adverse events in these patients.
- To understand the relationship between response, gene expression profile, biomarkers, and drug plasma concentrations in these patients.
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
结局指标
主要结局
Complete cytogenetic response rate
时间窗: At 12 months from study entry
次要结局
- Major and complete molecular response rate(At at 6, 12 and 24 months from study entry)
- Relationship between response, the gene expression profile, the biomarkers of leukemic cells, and plasma concentrations of nilotinib and imatinib mesylate(At 24 months from study entry)
- Complete cytogenetic response(At at 6 and 24 months from study entry)
- Development of BCR-ABL kinase domain mutations (number, timing, and type)(At at 24 months during and for 3 years after study treatment)
- Rate of failures and the time to failure(At 12, 24, and 60 months from study entry)
- Safety and tolerability(At 24 months from study entry)
- Frequency and type of adverse events (AE) and severe AE(At 24 months from study entry)
研究者
研究点 (50)
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