NCT02751112

Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Imagine Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-04-26
• Last updated: 2017-11-01

Locations

4 sites across 1 country: France