Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Evaluation of NK functions
研究概览
简要总结
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.
the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.
lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.
It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient aged 18 years and above,
- •Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
- •Signed consent to participate,
- •Patient affiliated to a social security system or benefiting from such as a system.
排除标准
- •Allogeneic patients beyond,
- •Patient deprived of liberty or under supervision of a guardian,
- •Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
结局指标
主要结局
Evaluation of NK functions
时间窗: Time from inclusion (Day 0) until Day 28
Evaluation with blood analysis
次要结局
- cytotoxic response therapy(Time from inclusion until relapse or death (until 5 years))