Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease (Predictor007)

Imagine Institute

Status: Terminated

Conditions: Hemopathy

Treatments: Biological: Predictor' kit

Study type: Interventional

Funder types: Other

Identifiers

NCT02751112

IMIS2014-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Couple donor / recipient

Experimental group

Description:

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.

Treatment:

Biological: Predictor' kit