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

September 27, 2021 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

227

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • Recruiting
        • Z.N.A. Stuivenberg Ziekenhuis
        • Contact:
        • Sub-Investigator:
          • Ka Lung WU
        • Sub-Investigator:
          • Nikki GRANACHER
        • Sub-Investigator:
          • Tom EYCKMANS
      • Liège, Belgium, 4000
        • Recruiting
        • CHU Liège
        • Contact:
        • Sub-Investigator:
          • Evelyne WILLENS, Dr
        • Sub-Investigator:
          • Frédéric BARON, Dr
        • Sub-Investigator:
          • Sophie SERVAIS, Dr
      • Wilrijk, Belgium, 2610
        • Recruiting
        • U.Z. Antwerpen
        • Contact:
  • France
      • Amiens, France, 80054
      • Angers, France, 49033
      • Caen, France, 14033
        • Recruiting
        • CHU de Caen
        • Contact:
      • Clamart, France, 92190
        • Recruiting
        • HIA Percy
        • Contact:
          • Jean-Valère MALFUSON, Pr
          • Phone Number: 01.41.46.63.07
          • Email: jvmalf@free.fr
      • Clermont-Ferrand, France, 63003
      • Limoges, France, 87042
      • Nantes, France, 44035
      • Nice, France, 06002
        • Recruiting
        • CHU NICE
        • Contact:
      • Paris, France, 75013
        • Recruiting
        • Hôpital de la Pitié-Salpêtrière
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • Hopital Necker Enfants Malades
        • Contact:
      • Pessac, France, 33604
      • Poitiers, France, 86000
      • Rennes, France, 35033
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • L'Institut de Cancérologie de la Loire
        • Contact:
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse
        • Contact:
      • Vandœuvre-lès-Nancy, France, 54511
        • Recruiting
        • CHRU Nancy - Hôpital de Brabois
        • Contact:
  • Germany
      • Dresden, Germany
        • Active, not recruiting
        • Donor Site-Dresden
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Michael STADLER
      • Köln, Germany
        • Active, not recruiting
        • Donor Site - Koln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of aGVHD of grade II to IV observed for the recipients
Time Frame: 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.
3 month after allograft performance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time Frame: 3 month after allograft performance.
Number of hospitalization or medical consultation, exams, concomitant treatments.
3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time Frame: 3 month after allograft performance.
Number of medical consultations
3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time Frame: 3 month after allograft performance.
Number of exams
3 month after allograft performance.
Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment
Time Frame: 3 month after allograft performance.
Number of concomitant treatments
3 month after allograft performance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Imagine Institute
Axonal-Biostatem
CERBA laboratory
SATT
SNC Graft Versus Host Disease

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Anticipated)

March 16, 2023

Study Completion (Anticipated)

March 16, 2023

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K180304J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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