Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft (CCR7-CD4-DPL)
Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.
研究概览
详细说明
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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LIlle、法国、59037
- Diseases of Blood Service HURIEZ hospital CHRU de LILLE
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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:
Inclusion criteria of the receiver anti -infectious immunity
- Man or woman aged 18-65 years
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent
Inclusion criteria for the study of the receiver of anti tumor immunity
- Man or woman aged 18-65 years
- Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)
- Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme )
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent receivers
Inclusion criteria of the donor
- Man or woman aged 18-65 years
- Member of the HLA-matched siblings and A, B, Cw, DR, DQ
- Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
- Having a rate of circulating lymphocytes ≥ 1 G / L
- Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
- The statutes CMV and EBV are known (positive or negative).
- Affiliated to social security person or beneficiary of such a scheme. who signed informed consent -
Exclusion Criteria:
Criteria for non inclusion of the pairs donor / Receiver
- Private person of liberty by judicial or administrative decision
- Person subject to a measure of legal protection
- Pregnant or breastfeeding woman
- People do not understand French or understanding with a disability.
- Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:receivers
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assessment pre-donation of hematopoietic stem cells (blood sample)
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实验性的:Donors
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assessment pre-donation of hematopoietic stem cells (blood sample)
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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 |
|---|---|---|
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Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
大体时间:1 day, 5 day ,8 day
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Decrease in alloreactivity of TCD4.(composite)
Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
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1 day, 5 day ,8 day
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Change the functional properties of cells will be evaluated by T-SPOT TB®.
大体时间:1 day, 5 day ,8 day
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Decrease in alloreactivity of TCD4.(composite)
Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
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1 day, 5 day ,8 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Response to anti-infectious immunity
大体时间:24 months
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Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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Response to anti-tumor immunity
大体时间:24 months
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Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
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24 months
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合作者和调查者
调查人员
- 研究主任:YAKOUB-AGHA IBRAHIM, Professor、CHRU de Lille
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2010_09
- 2010-A01231-38 (其他标识符:ID-RDB number, ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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