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Predictor2: Evaluation of a Donor Testing Kit for the Prediction of AGVHD in Patient Receiving a Peripheral Blood Stem Cell Allograft

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT03887156
Collaborator
SATT (Other), SNC Graft Versus Host Disease (Other), Imagine Institute (Other), Axonal-Biostatem (Industry), CERBA laboratory (Other)
227
Enrollment
22
Locations
1
Arm
42
Anticipated Duration (Months)
10.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test
 Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
227 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of a Donor Testing Kit for the Prediction of Acute GVHD in Patient Receiving a Peripheral Blood Stem Cells Allograft- Predictor 2
Actual Study Start Date :
Sep 16, 2019
Anticipated Primary Completion Date :
Mar 16, 2023
Anticipated Study Completion Date :
Mar 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

One arm

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.

Outcome Measures

Primary Outcome Measures

  1. Number of aGVHD of grade II to IV observed for the recipients [3 month after allograft performance]

    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.

Secondary Outcome Measures

  1. Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment [3 month after allograft performance.]

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

  2. Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment [3 month after allograft performance.]

    Number of medical consultations

  3. Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment [3 month after allograft performance.]

    Number of exams

  4. Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment [3 month after allograft performance.]

    Number of concomitant treatments

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Z.N.A. Stuivenberg Ziekenhuis Antwerpen Belgium 2060
2 CHU Liège Liège Belgium 4000
3 U.Z. Antwerpen Wilrijk Belgium 2610
4 CHU Amiens-Picardie Amiens France 80054
5 CHU Angers Angers France 49033
6 CHU de Caen Caen France 14033
7 HIA Percy Clamart France 92190
8 CHU Clermont-Ferrand Clermont-Ferrand France 63003
9 Hôpital Dupuyten Limoges France 87042
10 Hôtel Dieu Nantes France 44035
11 CHU Nice Nice France 06002
12 Hôpital de la Pitiè-Salpétrière Paris France 75013
13 Hôpital Necker Enfants Malades Paris France 75015
14 CHU Bordeaux Pessac France 33604
15 CHU de Poitiers Poitiers France 86000
16 CHU de Rennes Rennes France 35033
17 L'Institut de Cancérologie de la Loire Saint-Priest-en-Jarez France 42270
18 Institut Universitaire du Cancer de Toulouse Toulouse France 31059
19 CHRU Nancy - Hôpital de Brabois Vandœuvre-lès-Nancy France 54511
20 Donor Site-Dresden Dresden Germany
21 Medizinische Hochschule Hannover Hannover Germany
22 Donor Site - Koln Köln Germany

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • SATT
  • SNC Graft Versus Host Disease
  • Imagine Institute
  • Axonal-Biostatem
  • CERBA laboratory

Investigators

  • Principal Investigator: Olivier Hermine, MD, Head of adult hematology department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03887156
Other Study ID Numbers:
  • K180304J
First Posted:
Mar 22, 2019
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Preleukemia
Myelodysplastic Syndromes

Study Results

No Results Posted as of Sep 28, 2021