NL-OMON31183已完成3 期
A phase III randomized, open-label, multi-center study of nilotinib versus imatinib in adult patients with philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have suboptimal cytogenetic response (CyR) ib unatubub - CML chronic fase, suboptimal respons on imatinib, imatinib versus nilotinib
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
- •* 6-12 months of treatment and have 36-95% Ph+ metaphases or
- •* 12-18 months of treatment and have 1-35% Ph+ metaphases;EOG 0, 1, or 2;Patients must meet the following laboratory criteria:
- •Total bilirubin <1.5 X ULN
- •SGOT and SGPT <2.5 X ULN
- •Creatinine <1.5 X ULN
- •Serum potassium, phosphorus, magnesium and calcium >LLN or correctable with supplements prior to first dose of study drug.;Written informed consent.
排除标准
- •Previously documented T315I mutations;Achieved prior PCyR or CCyR on imatinib and lost that response prior to entering the study;Prior treatment with > 400 mg imatinib;Previous treatment with any other tyrosine kinase inhibitor except imatinib;Impaired cardiac function
研究者
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