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

Central Hospital, Nancy, France

Status: Completed

Conditions: Stem Cell Transplantation; Haplo-identical

Treatments: Other: Assessment of the Allogenomic Mismatch Score (AMS); Other: Assessment of the optimised Allogenomic Mismatch Score (AMS)

Study type: Observational

Funder types: Other

Identifiers

NCT05243498

2021PI066

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

80 participants in 4 patient groups

no acute GVH, no chronic GVH

Treatment:

Other: Assessment of the Allogenomic Mismatch Score (AMS)

Other: Assessment of the optimised Allogenomic Mismatch Score (AMS)

acute GVH without chronic GVH

Treatment:

Other: Assessment of the Allogenomic Mismatch Score (AMS)

Other: Assessment of the optimised Allogenomic Mismatch Score (AMS)

chronic GVH without acute GVH

Treatment:

Other: Assessment of the Allogenomic Mismatch Score (AMS)

Other: Assessment of the optimised Allogenomic Mismatch Score (AMS)

acute and chronic GVH

Treatment:

Other: Assessment of the Allogenomic Mismatch Score (AMS)

Other: Assessment of the optimised Allogenomic Mismatch Score (AMS)