JPRN-jRCTs041190038招募中2 期
An open-label, randomized, clinical trial of dasatinib vs. nilotinib in the treatment of children with chronic and accelerated phase chronic myeloid leukemia. - JPLSG-CML-17
Keino Dai0 个研究点目标入组 65 人开始时间: 2019年6月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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
- ot applicable 至 < 18age old（—）
- 性别
- All
入选标准
- •1) prior enrollment to JPLSG-CHM-14 study
- •2) BCR-ABL1 positive CML
- •3) chronic or accelerated phase at diagnosis and no history of disease progression
- •4) patients who have no history of TKI treatment other than imatinib or who are imatinib-resistant and/or intolerant
- •5) < 18 years of age at enrollment
- •6) ECOG PS 0-2 (CML-related PS 3 is allowed)
- •7) written informed consent obtained from patient and/or guardian
排除标准
- •1) previously documented highly resistant mutations to dasatinib and/or nilotinib
- •2) QTcF >=0.45 second
- •3) pregnant or lactating female including who plans to be pregnant during clinical trial
- •4) positive allergic history to excipients of dasatinib or nilotinib
- •5) prior allogeneic hematopoietic stem cell transplantation for CML
- •6) uncontrolled or sever comorbidities
- •7) patients who are ineligible decided by pediatricians
研究者
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