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

NCT ID: NCT02751112

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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

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Hemopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Predictor' kit

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

Exclusion Criteria

* Participation to a therapeutical protocol in the 30 last days
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imagine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier de Caen

Caen, , France

Site Status

Hôpital de Huriez / CHRU de Lille

Lille, , France

Site Status

Hôpital Necker Enfants Malades

Paris, , France

Site Status

Hôpital Haut-Lévèque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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IMIS2014-03

Identifier Type: -

Identifier Source: org_study_id