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Completed

NCT Number: NCT05243498

Allogenomic Mismatch Score (AMS) Applied to Haplo-identical Donor/Recipient Pairs in Haematopoietic Stem Cell Transplantation

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

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Key information

Conditions

Stem Cell Transplantation Haplo-identical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alice Aarnink

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • Recipient died within the 6 months following the transplantation without acute GVH (unknown status for one of the measured outcomes)

Treatment and study plan

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).

Primary outcomes

  1. 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"

Secondary outcomes

  1. Predictive performance of AMS regarding the occurence of acute GVH

    Time frame: 6 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 aGVH" and "absence of aGVH"

  2. Predictive performance of an optimised AMS regarding the occurence of chronic GVH

    Time frame: 12 months after each transplantation

    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"

  3. Predictive performance of an optimised AMS regarding the occurence of acute GVH

    Time frame: 6 months after each transplantation

    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"

  4. Predictive performance of AMS regarding the occurence of relapse

    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 "relapse" and "no relapse"

  5. Predictive performance of an optimised AMS regarding the occurence of relapse

    Time frame: 12 months after each transplantation

    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"

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: AMS-haplo

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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