NCT05080829Unknown不适用
ABL Mutation Register in Patients With ITK Relapsed or Refractory Chronic Myeloid Leukemia
Grupo Cooperativo de Hemopatías Malignas2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Presence of myeloid mutations by Next Generation Sequence
研究概览
简要总结
The aim of the study is to know the percentage of ABL mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by NGS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CML diagnosis by the WHO 2016 criteria
- •Failure to reach cytogenetic response of Ph chromosome of 36 to 95% at 3 months or BCR/ABL <10% at 6 months of treatment with TKI
- •Progression or relapse of the disease after previous response to treatment with TKI
- •Validation of adherence to treatment
- •Inform consent
排除标准
- •Lack of information to complete the register
- •Failure to response achievement due lack of adherence to treatment
结局指标
主要结局
Presence of myeloid mutations by Next Generation Sequence
时间窗: 1 year
Detection of positive myeloid mutations at detection of relapse or refractoriness to ITK treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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