NCT03887156

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
227

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Geographic Reach
3 countries

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

March 12, 2019

Last Update Submit

September 27, 2021

Conditions

Acute Myeloid Leukemia in RemissionLymphoma in RemissionNon-progressive Myeloproliferative SyndromeMyelodysplasia With Stable Blasts is Cell Number and < 10% of BlastocystsAcute Leukemia Biphenotypic in RemissionAcute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evaluation of medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment

    3 month after allograft performance.

  • Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment

    3 month after allograft performance.

  • Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment

    3 month after allograft performance.

  • Evaluation of the medico-economic aspect of the Predictor test Total estimated cost of the aGVHD treatment

    3 month after allograft performance.

Study Arms (1)

Arm 1

OTHER

One arm

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

Interventions

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

Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ,
  • +1 more criteria

You may not qualify if:

  • Being placed under legal supervision ,
  • Presenting any impossibility to fulfil the study requirements, due to geographical, social or physical reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Z.N.A. Stuivenberg Ziekenhuis

Antwerp, 2060, Belgium

RECRUITING

CHU Liège

Liège, 4000, Belgium

RECRUITING

U.Z. Antwerpen

Wilrijk, 2610, Belgium

RECRUITING

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

CHU Angers

Angers, 49033, France

RECRUITING

CHU de Caen

Caen, 14033, France

RECRUITING

HIA Percy

Clamart, 92190, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Hôpital Dupuyten

Limoges, 87042, France

RECRUITING

Hôtel Dieu

Nantes, 44035, France

RECRUITING

CHU Nice

Nice, 06002, France

RECRUITING

Hôpital de la Pitiè-Salpétrière

Paris, 75013, France

RECRUITING

Hôpital Necker Enfants Malades

Paris, 75015, France

RECRUITING

CHU Bordeaux

Pessac, 33604, France

RECRUITING

CHU de Poitiers

Poitiers, 86000, France

RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

L'Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42270, France

RECRUITING

Institut Universitaire du Cancer de Toulouse

Toulouse, 31059, France

RECRUITING

CHRU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Donor Site - Koln

Cologne, Germany

ACTIVE NOT RECRUITING

Donor Site-Dresden

Dresden, Germany

ACTIVE NOT RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27740636BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Olivier Hermine, MD

    Head of adult hematology department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick VACHER

CONTACT

+33 1 44 84 17 30yannick.vacher@aphp.fr

Marie-Lou CAMUT

CONTACT

+33 1 56 38 21 77mlcamut@axonal.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 22, 2019

Study Start

September 16, 2019

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)FR(16)BE(3)