Hemopathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALPredictor' kit
Realization of the Predictor' kit on the blood of donor of HSC, in the frame of a graft, to predict a aGvH reaction on recipient patient.
Sponsors
Imagine Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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 Main
Exclusion criteria
* Participation to a therapeutical protocol in the 30 last days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the diagnosis test performance | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the reproductibility of the test | 6 months | The reproductibility of the test will be assessed by comparing the results obtained by 2 distinct operators : the immunology lab technician, and the referent operator at Imagine Institute research lab. The 2 operators will perform the test in parallel on the blood of the same donor, in similar conditions, and both by using a Predictor's kit. |
Countries
France
Outcome results
None listed