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临床试验/NCT05152537
NCT05152537Unknown不适用

A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia

Affiliated Hospital of Nantong University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
1
主要终点
treatment-free remission or relapse

研究概览

简要总结

For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

详细描述

Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient signs the informed consent form
  • Age over 18, male or female
  • The patient was diagnosed as chronic phase of CML.
  • ECoG score 0-2
  • Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
  • The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.

排除标准

  • 未提供

结局指标

主要结局

treatment-free remission or relapse

时间窗: 1 year

Observe whether the patients were in remission or relapse 1 year after drug withdrawal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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