HemopathyPredictor007NCT02751112
Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
A study testing Predictor' kit in people with Hemopathy, run by Imagine Institute at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemopathy
- What is being tested?
- Predictor' kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier de Caen
Caen
Hôpital de Huriez / CHRU de Lille
Lille
Hôpital Necker Enfants Malades
Paris
Hôpital Haut-Lévèque
Pessac
About this study
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.
Read the 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.
- Conditions
- Hemopathy
- Being tested
- Predictor' kit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictor' kitBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Couple donor / recipient | Experimental | 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. Receives: Biological: Predictor' kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Slow recruitment and preliminary observations leading to early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751112
- Sponsor's protocol ID
- IMIS2014-03
- Acronym
- Predictor007
- Status last verified
- Aug 2017
- First submitted
- 13 Apr 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Kit for the Prediction of the Risk of Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT02751112
- Acronym / sponsor ID
- Predictor007 / IMIS2014-03
- Conditions
- Hemopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment and preliminary observations leading to early termination
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couple donor / recipient | Experimental | Biological: Predictor' kitEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictor' kitRealization 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. | Biological | Couple donor / recipient |
Primary outcome
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
1 secondary outcome
Assessment of the reproductibility of the test
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Slow recruitment and preliminary observations leading to early termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Predictor' kit in people with Hemopathy, run by Imagine Institute at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment and preliminary observations leading to early termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the diagnosis test performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.