Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Assessment of the diagnosis test performance
研究概览
简要总结
This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.
In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.
详细描述
The Hematopoietic Stem Cell (HSC) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias.
The acute Graft versus Host (aGvH) reaction is the most frequent complication, and could concern until 50% of recipients. It is mainly linked to immune characteristics of the donor which will act versus the graft recipient.
There is a huge need of a technology that could predict the risk of aGvH, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft.
The Predictor' kit allows to predict acute and severe forms of Graft versus Host disease before the graft of peripheral hematological stem cells, by the assesment of iNKT cells expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion Criteria for Donors :
- •Being a relative of the recipient patient, OR being registered on the National Registry of the volunteers for bone marrow donation
- •Being candidate for a donation of Hematologic Stem Cells with a HLA compatibility 10/10
- •Main inclusion Criteria for Recipient :
- •Being candidate for a donation of Hematologic Stem Cells with the following criteria:
- •HLA compatibility 10/10 with the donor
- •Suffering from malignant or non-malignant hemopathy in first remission
- •Myeloablative or reducted intensity conditioning
- •Classic scheme of immunosuppression decreasing
排除标准
- •Participation to a therapeutical protocol in the 30 last days
研究组 & 干预措施
Couple donor / recipient
Each couple will be treated the same way :
An additional blood sample of the donor will be taken prior GCSF mobilization. This blood sample will then be analyzed via Predictor's kit, by the immunology laboratory of the hospital where the graft will be done.
Whatever the result given by the Predictor' kit, the graft will be done for the recipient patient. No change will be done on the usual graft process.
干预措施: Predictor' kit (Biological)
结局指标
主要结局
Assessment of the diagnosis test performance
时间窗: 6 months
The performance of the test will be assessed via the observation of the number of aGvH 6 months after the graft, reported to the the expansion of iNKT cells. Assessment of sensitivity and specificity of the diagnosis test
次要结局
- Assessment of the reproductibility of the test(6 months)