JPRN-jRCT2080222098已完成2 期
A phase II, single arm, open label study of treatment-free remission in Chronic Myeloid Leukemia (CML) chronic phase (CP) patients after achieving sustained MR4.5 on nilotinib
ovartis Pharma0 个研究点目标入组 117 人开始时间: 2013年6月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main Includion criteria
- •1) ECOG Performance Status of 0, 1, or 2
- •2) Patient with diagnosis of BCR-ABL positive CML CP
- •3) Patient has received a minimum of 3 years of tyrosine kinase inhibitor
- •treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
- •4) Patient has at least 2 years of nilotinib treatment prior to study entry
- •5) Patient has achieved MR4.5 during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
- •6) Adequate bone marrow and organ function meeting laboratory criteria
排除标准
- •Main Exclusion criteria
- •1) Prior AP, BC or allo-transplant
- •2) Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
- •3) Patients with known atypical transcript.
- •4) CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past
- •5) Severe and/or uncontrolled concurrent medical disease
- •6) History of other active malignancy within 5 years prior to study entry
- •7) Pregnant or nursing (lactating) women
研究者
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