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 (CAMN107A2408)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Treatment-free remission (TFR)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Single armx, Open label, multi-center trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Main Includion criteria
- •ECOG Performance Status of 0, 1, or 2
- •Patient with diagnosis of BCR-ABL positive CML CP
- •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
- •Patient has at least 2 years of nilotinib treatment prior to study entry
- •Patient has achieved MR4.5 during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening
- •Adequate bone marrow and organ function meeting laboratory criteria
排除标准
- •Main Exclusion criteria
- •Prior AP, BC or allo-transplant
- •Patient has documented MR4.5 at the time when switched from imatinib to nilotinib
- •Patients with known atypical transcript.
- •CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if testing was done in the past
- •Severe and/or uncontrolled concurrent medical disease
- •History of other active malignancy within 5 years prior to study entry
- •Pregnant or nursing (lactating) women
结局指标
主要结局
Treatment-free remission (TFR)
时间窗: 12 months
To evaluate the proportion of patients in Treatment-free remission (TFR) following nilotinib cessation
次要结局
- TFR
- PFS
- TFS
- OS
- BCRABL transcript kinetics
研究者
研究点 (1)
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