Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft
NCT ID: NCT03887156
Last Updated: 2021-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
227 participants
INTERVENTIONAL
2019-09-16
2023-03-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1
One arm
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Being placed under legal supervision ,
* Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons
18 Years
65 Years
ALL
No
Sponsors
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SATT
UNKNOWN
SNC Graft Versus Host Disease
UNKNOWN
Imagine Institute
OTHER
Axonal-Biostatem
INDUSTRY
CERBA laboratory
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Olivier Hermine, MD
Role: PRINCIPAL_INVESTIGATOR
Head of adult hematology department
Locations
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Z.N.A. Stuivenberg Ziekenhuis
Antwerp, , Belgium
CHU Liège
Liège, , Belgium
U.Z. Antwerpen
Wilrijk, , Belgium
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, , France
Donor Site - Koln
Cologne, , Germany
Donor Site-Dresden
Dresden, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Countries
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Central Contacts
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Facility Contacts
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Michael STADLER
Role: primary
References
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Rubio MT, Bouillie M, Bouazza N, Coman T, Trebeden-Negre 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.
Other Identifiers
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K180304J
Identifier Type: -
Identifier Source: org_study_id
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