Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.
研究概览
简要总结
Purpose:
The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).
详细描述
Method: prospective, monocentric, descriptive study
Primary objective:
Evaluation of the expression and function of receptors activator of NK cell (KIRs) in patients with CLL at stage A with therapeutic abstention, or stage B or C which require a treatment.
Secondary objectives:
Measure of the evolution of cytotoxic function of NK cells and theirs biomarkers of activation when the patient receives an immunochemotherapy with Rituximab/ Fludarabine/ Cyclophosphamide (RCF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Diagnosis of CLL (Score of Matutes >=4) with no history of treatment: Stade A of Binet, Or Stade B or C before the beginning of the treatment with RFC
- •Patients who can undergo blood collection
- •Patient aged 18 years and older
- •Signed consent
- •Non inclusion Criteria:
- •Patient with anemia: haemoglobin < 9 g/dl
- •Pregnancy, breast feeding
- •Patient in an urgent situation, or unable to give a consent
排除标准
- 未提供
结局指标
主要结局
Analysis of the surface expression of functional biomarkers of the NK cell, functional study, analysis of expression of transcription of values genes.
时间窗: 1 day
次要结局
未报告次要终点