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

October 30, 2017 updated by: Imagine Institute

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Centre Hospitalier de Caen
      • Lille, France
        • Hôpital de Huriez / CHRU de Lille
      • Paris, France
        • Hôpital Necker Enfants Malades
      • Pessac, France
        • Hôpital Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIS2014-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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