Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease (Predictor007)
Primary Purpose
Hemopathy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Predictor' kit
Sponsored by
About this trial
This is an interventional prevention trial for Hemopathy
Eligibility 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
Sites / Locations
- Centre Hospitalier de Caen
- Hôpital de Huriez / CHRU de Lille
- Hôpital Necker Enfants Malades
- Hôpital Haut-Lévèque
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Couple donor / recipient
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02751112
Brief Title
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
Acronym
Predictor007
Official Title
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment and preliminary observations leading to early termination
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imagine Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Couple donor / recipient
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Predictor' kit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the diagnosis test performance
Description
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 Outcome Measure Information:
Title
Assessment of the reproductibility of the test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier de Caen
City
Caen
Country
France
Facility Name
Hôpital de Huriez / CHRU de Lille
City
Lille
Country
France
Facility Name
Hôpital Necker Enfants Malades
City
Paris
Country
France
Facility Name
Hôpital Haut-Lévèque
City
Pessac
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
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