Study Stopped
Slow recruitment and preliminary observations leading to early termination
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
Predictor007
1 other identifier
interventional
34
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedNovember 1, 2017
August 1, 2017
1.8 years
April 13, 2016
October 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (1)
Assessment of the reproductibility of the test
6 months
Study Arms (1)
Couple donor / recipient
EXPERIMENTALEach 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.
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Participation to a therapeutical protocol in the 30 last days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 26, 2016
Study Start
November 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
November 1, 2017
Record last verified: 2017-08