Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease (Predictor007)
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|ClinicalTrials.gov Identifier: NCT02751112|
Recruitment Status : Terminated (Slow recruitment and preliminary observations leading to early termination)
First Posted : April 26, 2016
Last Update Posted : November 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hemopathy||Biological: Predictor' kit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Experimental: 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.
Biological: Predictor' 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.
- Assessment of the diagnosis test performance [ Time Frame: 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
- Assessment of the reproductibility of the test [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751112
|Centre Hospitalier de Caen|
|Hôpital de Huriez / CHRU de Lille|
|Hôpital Necker Enfants Malades|