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

Imagine Institute34 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hemopathy

Interventions

Predictor' kitBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (4)

Centre Hospitalier de Caen

Caen, France

Hôpital de Huriez / CHRU de Lille

Lille, France

Hôpital Necker Enfants Malades

Paris, France

Hôpital Haut-Lévèque

Pessac, France

Outcomes

Primary Outcomes

Assessment of the diagnosis test performance

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

Time frame: 6 months

Secondary Outcomes

Assessment of the reproductibility of the test

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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.