NCT02842333已完成不适用
Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- UCP-specific Th1 responses measured by ELISPOT assay
研究概览
简要总结
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.
The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For cohort A :
- •patient with chronic myelogenous leukemia in chronic phase in deep molecular response (MR4.0) persistent for 2 years or more after end of TKi treatments
- •patient with total cessation of TKi treatment
- •signed written informed consent
- •For cohort B :
- •patient with chronic myelogenous leukemia in chronic phase, for whom a diagnosis of relapse was increased 1 year or less after stopping treatment with TKIs (inclusion of patient under TKi treatment after relapse is possible).
- •signed written informed consent
- •Exclusion Criteria (for all patients) :
- •patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (corticoids ≤ 10 mg/day is allowed)
- •active autoimmune diseases, HIV, hepatitis C or B virus
- •patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
- •patient under guardianship, curator or under the protection of justice.
排除标准
- 未提供
结局指标
主要结局
UCP-specific Th1 responses measured by ELISPOT assay
时间窗: at inclusion
次要结局
未报告次要终点
研究者
研究点 (4)
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