跳至主要内容
临床试验/NCT02842320
NCT02842320已完成不适用

Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

Centre Hospitalier Universitaire de Besancon4 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2015年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
4
主要终点
IL1RAP protein expression on the surface of cells detected by flow cytometry

研究概览

简要总结

The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML).

Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (> RM4.0).

Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients for whom there is a strong suspicion of CML diagnosed as part of routine activity.
  • written informed consent

排除标准

  • patient with atypical CML
  • patient with a non SMP CML
  • patients previously treated with interferon
  • patient enrolled in another study therapy or within the exclusion period thereof
  • pregnant or breast-feeding women
  • patient under guardianship, curator or under the protection of justice.

结局指标

主要结局

IL1RAP protein expression on the surface of cells detected by flow cytometry

时间窗: up to 2 years after inclusion

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 (4)

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