Stem Cell TransplantationAMS-haploNCT05243498
Allogenomic Mismatch Score (AMS) Applied to Haplo-identical Donor/Recipient Pairs in Haematopoietic Stem Cell Transplantation
An observational study of Stem Cell Transplantation and Haplo-identical, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The occurrence of acute and/or chronic GVH (Graf Versus Host disease) for recipients undergoing HSCT (haematopoietic stem cell transplantation) with a geno-identical donor suggests the implication of other systems or genes than those involved in HLA (Human Leukocyte Antigen) compatibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplantation, Haplo-identical
- What is being tested?
- Assessment of the Allogenomic Mismatch Score (AMS) and Assessment of the optimised Allogenomic Mismatch Score (AMS)
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2015to 6 Nov 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 haplo-identical donor/recipient pairs
Who may be able to join
- - Recipients who underwent haplo-identical stem cell transplantation in CHRU (Centre Hospitalier Régional et Universitaire) de Nancy
- Recipients transplanted between 03/01/2015 et 01/01/2020
- Recipient older than 18 years old at time of transplant
- Available DNA for the recipient and his donor.
Who cannot join
- Recipient died within the 6 months following the transplantation without acute GVH (unknown status for one of the measured outcomes)
Trial locations and contacts
1 site in 1 country.
About this study
The occurrence of acute and/or chronic GVH (Graf Versus Host disease) for recipients undergoing HSCT (haematopoietic stem cell transplantation) with a geno-identical donor suggests the implication of other systems or genes than those involved in HLA (Human Leukocyte Antigen) compatibility.
In kidney transplantation, it has been shown that the AMS (allogenomic mismatch score) is correlated with the probability of survival of the graft. This AMS reflects the degree of differences between the immunopeptidomes of the recipient and his donor as it is a continuous variable based on the number of nsSNP (non synonymous Single Nucletotide Polymorphism) between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in in the donor. In this case, peptide presented by the recipient's cells is not part of the donor's immunopeptidome, leading to an activation of the donor's immunocompetent cells toward this antigen, i.e. to alloreactivity that may cause GVL (Graft Versus Leukemia) and/or GVH.
Read more
This study aims to highlight significant correlations between the occurrence of acute and/or chronic GVH after haplo-identical stem cell transplantation and the AMS.
This would allow to use the AMS as a predictive factor of acute or chronic GVH, which could be employed to select the best donor for one particular recipient and/or personalize the immunotherapies after transplantation
- Conditions
- Stem Cell Transplantation, Haplo-identical
- Being tested
- Assessment of the Allogenomic Mismatch Score (AMS), Assessment of the optimised Allogenomic Mismatch Score (AMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the Allogenomic Mismatch Score (AMS)Other
Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor.
Assessment of the optimised Allogenomic Mismatch Score (AMS)Other
Optimised Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient, encountering only peptides that can be presented by the donors' MHC (using another layer of algorithm, NetMHCpan).
| Study group | Role | What they receive |
|---|---|---|
| no acute GVH, no chronic GVH | Not described Receives: Other: Assessment of the Allogenomic Mismatch Score (AMS); Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) | |
| acute GVH without chronic GVH | Not described Receives: Other: Assessment of the Allogenomic Mismatch Score (AMS); Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) | |
| chronic GVH without acute GVH | Not described Receives: Other: Assessment of the Allogenomic Mismatch Score (AMS); Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) | |
| acute and chronic GVH | Not described Receives: Other: Assessment of the Allogenomic Mismatch Score (AMS); Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance of AMS regarding the occurence of chronic GVH
Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor. The comparison of AMS will be performed between the groups "presence of cGVH" and "absence of cGVH"
Measured: 12 months after each transplantation
Secondary outcomes (5)
Predictive performance of AMS regarding the occurence of acute GVH
Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor. The comparison of AMS will be performed between the groups "presence of aGVH" and "absence of aGVH"
Measured: 6 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of chronic GVH
Optimised Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient, encountering only peptides that can be presented by the donors' MHC (using another layer of algorithm, NetMHCpan). The comparison of optimised AMS will be performed between the groups "presence of cGVH" and "absence of cGVH"
Measured: 12 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of acute GVH
Optimised Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient, encountering only peptides that can be presented by the donors' MHC (using another layer of algorithm, NetMHCpan). The comparison of optimised AMS will be performed between the groups "presence of aGVH" and "absence of aGVH"
Measured: 6 months after each transplantation
Predictive performance of AMS regarding the occurence of relapse
Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor. The comparison of AMS will be performed between the groups "relapse" and "no relapse"
Measured: 12 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of relapse
Optimised Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient, encountering only peptides that can be presented by the donors' MHC (using another layer of algorithm, NetMHCpan). The comparison of optimised AMS will be performed between the groups "relapse" and "no relapse"
Measured: 12 months after each transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start23 Mar 2015
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice AARNINK, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243498
- Sponsor's protocol ID
- 2021PI066
- Acronym
- AMS-haplo
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenomic Mismatch Score (AMS) Applied to Haplo-identical Donor/Recipient Pairs in Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05243498
- Acronym / sponsor ID
- AMS-haplo / 2021PI066
- Conditions
- Stem Cell Transplantation, Haplo-identical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 17 Feb 2022 (actual)
- 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.
The occurrence of acute and/or chronic GVH (Graf Versus Host disease) for recipients undergoing HSCT (haematopoietic stem cell transplantation) with a geno-identical donor suggests the implication of other systems or genes than those involved in HLA (Human Leukocyte Antigen) compatibility.
In kidney transplantation, it has been shown that the AMS (allogenomic mismatch score) is correlated with the probability of survival of the graft. This AMS reflects the degree of differences between the immunopeptidomes of the recipient and his donor as it is a continuous variable based on the number of nsSNP (non synonymous Single Nucletotide Polymorphism) between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in in the donor. In this case, peptide presented by the recipient's cells is not part of the donor's immunopeptidome, leading to an activation of the donor's immunocompetent cells toward this antigen, i.e. to alloreactivity that may cause GVL (Graft Versus Leukemia) and/or GVH.
This study aims to highlight significant correlations between the occurrence of acute and/or chronic GVH after haplo-identical stem cell transplantation and the AMS.
This would allow to use the AMS as a predictive factor of acute or chronic GVH, which could be employed to select the best donor for one particular recipient and/or personalize the immunotherapies after transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no acute GVH, no chronic GVH | – | Other: Assessment of the Allogenomic Mismatch Score (AMS), Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) |
| acute GVH without chronic GVH | – | Other: Assessment of the Allogenomic Mismatch Score (AMS), Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) |
| chronic GVH without acute GVH | – | Other: Assessment of the Allogenomic Mismatch Score (AMS), Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) |
| acute and chronic GVH | – | Other: Assessment of the Allogenomic Mismatch Score (AMS), Other: Assessment of the optimised Allogenomic Mismatch Score (AMS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 haplo-identical donor/recipient pairs
Key inclusion criteria (4 listed)
- - Recipients who underwent haplo-identical stem cell transplantation in CHRU (Centre Hospitalier Régional et Universitaire) de Nancy
- Recipients transplanted between 03/01/2015 et 01/01/2020
- Recipient older than 18 years old at time of transplant
- Available DNA for the recipient and his donor.
Key exclusion criteria (1 listed)
- Recipient died within the 6 months following the transplantation without acute GVH (unknown status for one of the measured outcomes)
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 |
|---|---|---|
| Assessment of the Allogenomic Mismatch Score (AMS)Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor. | Other | acute GVH without chronic GVH, acute and chronic GVH, chronic GVH without acute GVH, no acute GVH, no chronic GVH |
| Assessment of the optimised Allogenomic Mismatch Score (AMS)Optimised Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient, encountering only peptides that can be presented by the donors' MHC (using another layer of algorithm, NetMHCpan). | Other | acute GVH without chronic GVH, acute and chronic GVH, chronic GVH without acute GVH, no acute GVH, no chronic GVH |
Primary outcome
Predictive performance of AMS regarding the occurence of chronic GVH
Time frame: 12 months after each transplantation
Allogenomic Mismatch Score (AMS) is a continuous variable based on the number of nsSNP between the donor and the recipient. Roughly, the exome of the donor is aligned to the exome of the recipient, allowing to count the number of variations that will generate a peptide present in the recipient but absent in the donor. The comparison of AMS will be performed between the groups "presence of cGVH" and "absence of cGVH"
5 secondary outcomes
Predictive performance of AMS regarding the occurence of acute GVH
Time frame: 6 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of chronic GVH
Time frame: 12 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of acute GVH
Time frame: 6 months after each transplantation
Predictive performance of AMS regarding the occurence of relapse
Time frame: 12 months after each transplantation
Predictive performance of an optimised AMS regarding the occurence of relapse
Time frame: 12 months after each transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplantation and Haplo-identical, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive performance of AMS regarding the occurence of chronic GVH (time frame: 12 months after each transplantation). 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 17 Feb 2022.