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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03887156
Other study ID # K180304J
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 16, 2019
Est. completion date March 16, 2023

Study information

Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Yannick VACHER
Phone +33 1 44 84 17 30
Email yannick.vacher@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 227
Est. completion date March 16, 2023
Est. primary completion date March 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - PATIENT : - Age between 18 and 65 years ( included ) - Being candidate to a graft of peripheral hematopoietic stem cells , according the following criteria : - HLA compatibility 10 / 10 with the selected donor - Malignant haematological disorder as described below : - Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia ( ALL) in 1st or 2d complete remission - Aggressive lymphoma in complete remission - Non - progressive myeloproliferative syndrome , - Myelodysplasia with stable blasts is cell number and < 10 % of blastocysts, - Acute leukemia biphenotypic in 1st or 2d complete remission - Sequential graft conditioning, myeloablative or with a reduced intensity, both may include ATG - Classical scheme for immunosuppression decrease ( from day 90 to day 180 ) • Not being opposed to medical data collection DONOR - Adult ( = 18 year old) up to the maximum authorized by each National Transplantation Authority - Being a patient's sibling or registered in the Bone Marrow Donors Worldwide registry or a national registry - Being candidate to a Peripheral Blood Stem Cells donation with a Human Leucocyt Antigen (HLA) 10 / 10 compatibility with the recipient , - Signed and dated informed consent ( in accordance with local regulation of the country in which the observation is performed ) Exclusion Criteria: - Participating in a clinical trial, if interventional on the prophylaxis treatment ( not on the prophylaxis ) of GVHD, in the 30 days prior to the inclusion and during the Predictor 2 study , - Being placed under legal supervision , - Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test
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.

Locations

Country Name City State
Belgium Z.N.A. Stuivenberg Ziekenhuis Antwerpen
Belgium CHU Liège Liège
Belgium U.Z. Antwerpen Wilrijk
France CHU Amiens-Picardie Amiens
France CHU Angers Angers
France CHU de Caen Caen
France HIA Percy Clamart
France CHU Clermont-Ferrand Clermont-Ferrand
France Hôpital Dupuyten Limoges
France Hôtel Dieu Nantes
France CHU Nice Nice
France Hôpital de la Pitiè-Salpétrière Paris
France Hôpital Necker Enfants Malades Paris
France CHU Bordeaux Pessac
France CHU de Poitiers Poitiers
France CHU de Rennes Rennes
France L'Institut de Cancérologie de la Loire Saint-Priest-en-Jarez
France Institut Universitaire du Cancer de Toulouse Toulouse
France CHRU Nancy - Hôpital de Brabois Vandœuvre-lès-Nancy
Germany Donor Site-Dresden Dresden
Germany Medizinische Hochschule Hannover Hannover
Germany Donor Site - Koln Köln

Sponsors (6)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Axonal-Biostatem, CERBA laboratory, Imagine Institute, SATT, SNC Graft Versus Host Disease

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

References & Publications (1)

Rubio MT, Bouillié M, Bouazza N, Coman T, Trebeden-Nègre H, Gomez A, Suarez F, Sibon D, Brignier A, Paubelle E, Nguyen-Khoc S, Cavazzana M, Lantz O, Mohty M, Urien S, Hermine O. Pre-transplant donor CD4(-) invariant NKT cell expansion capacity predicts the occurrence of acute graft-versus-host disease. Leukemia. 2017 Apr;31(4):903-912. doi: 10.1038/leu.2016.281. Epub 2016 Oct 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of aGVHD of grade II to IV observed for the recipients 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. 3 month after allograft performance
Secondary Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment Number of hospitalization or medical consultation, exams, concomitant treatments. 3 month after allograft performance.
Secondary Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment Number of medical consultations 3 month after allograft performance.
Secondary Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment Number of exams 3 month after allograft performance.
Secondary Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment Number of concomitant treatments 3 month after allograft performance.
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