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Calculation of ex vivo capacities of CD4neg INkT expansion of the peripheral blood from an identified donor for an allograft. Sample is collected before mobilization and the blood culture and analysis using the Predictor test are performed by the central lab.

Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test

Yannick VACHER

Marie-Lou CAMUT

Dimitri BREEMS

Ka Lung WU

Nikki GRANACHER

Tom EYCKMANS

Yves BEGUIN, Pr

Evelyne WILLENS, Dr

Frédéric BARON, Dr

Sophie SERVAIS, Dr

Anke VERLINDEN, Dr

Magalie JORIS, Dr

Sylvie FRANCOIS, Dr

Hyacinthe Atchroué JOHNSON-ANSAH, Dr

Jean-Valère MALFUSON, Pr

Lemal RICHARD, Dr

Arnaud JACCARD, Dr

Patrice CHEVALLIER, Dr

Pierre-Simon ROHRLICH, Dr

Stéphanie NGUYEN-QUOC, Pr

Olivier HERMINE, Pr

Carmen BOTELLA GARCIA, Dr

Natacha MAILLARD, Dr

Marc BERNARD, Dr

Emilie CHALAYER, Dr

Anne HUYNH, Dr

Marie-Thérèse RUBIO

Michael STADLER

Olivier Hermine, MD

The aim is to validate an in vitro diagnosis medical device to predict grade II to IV aGVHD after a cell graft

Acute Graft Versus Host Disease (aGVHD) is the most frequent complication in allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT). It affects up to 50% patients, among whom 15% to 25% develop severe forms, often lethal, yet impossible to predict even for donors with a Human Leukocyte Antigene (HLA) 10/10 compatibility. Global Overall Survival (OS) after transplantation is 40% to 60% only due to post transplant severe complications. There is a major medical need for a technology that would predict the risk of aGVHD and would allow the selection of a favourable donor among multiple Human Leukocyte Antigene (HLA)10/10 compatible donors.

MT. Rubio and M. Bouillié at Pr Olivier Hermine's lab previously reported that enhanced early post-transplant invariant Natural Killer T (iNKT) cells reconstitution from donor cells was correlated to reduced risk of aGVHD, without impairment of the Graft Versus Leukemia (GVL) effect. They subsequently demonstrated that the expansion of donors CD4neg invariant Natural Killer T (iNKT) cells subpopulation was predictive of a reduced risk of aGVHD, and developed a method for predicting this risk based on the expansion factor of CD4neg invariant Natural Killer T (iNKT) cells in the peripheral blood stem cell (PBSC) graft. This invariant Natural Killer T (iNKT) cells functional test reaches its optimal predictive capacity with 94% sensitivity and 100% specificity in allo-HSCT performed with Human Leukocyte Antigene (HLA) 10/10 matched peripheral blood stem cell (PBSC) grafts for non-progressive hematological malignant diseases, in complete response, which represent the majority of the indications of allogeneic HSCT. Similar predictive value was also observed when the test was performed from donor's peripheral blood before G-CSF mobilization. It was not associated with an increased risk of relapse. This test could therefore allow to easily selecting the best donor if different siblings or unrelated donors are available before PBSC allo-HSCT.

Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft

Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2

To predict the risk of acute GVHD. Number of aGVHD of grade II to IV observed for the recipients in the 3 months after the graft and results of the Predictor test, before graft, on their own donor's blood.

Number of hospitalization or medical consultation, exams, concomitant treatments.

Spots Global Cancer Trial Database for ex vivo capacities of cd4neg inkt expansion of the peripheral blood donor with the predictor test