Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide
Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies
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.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Marseille、法国、13009
- Thomas PREBET, MD
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Acute myeloïd leukemia
Realization of 3 blood samples at day 0, day 15 and day 28.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of NK functions
大体时间：Time from inclusion (Day 0) until Day 28
|
Evaluation with blood analysis
|
Time from inclusion (Day 0) until Day 28
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cytotoxic response therapy
大体时间：Time from inclusion until relapse or death (until 5 years)
|
Evaluation of cytotoxic response therapy with lenalidomide
|
Time from inclusion until relapse or death (until 5 years)
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合作者和调查者
调查人员
- 首席研究员：Thomas PREBET, MD、Institut Paoli-Calmettes
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.