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

NCT03887156 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2021-09-28

No results posted yet for this study

Summary

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

Conditions

  • Acute Myeloid Leukemia in Remission
  • Lymphoma in Remission
  • Non-progressive Myeloproliferative Syndrome
  • Myelodysplasia With Stable Blasts is Cell Number and < 10% of Blastocysts
  • Acute Leukemia Biphenotypic in Remission
  • Acute Lymphoblastic Leukemia

Interventions

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.

Sponsors & Collaborators

  • SATT

    collaborator UNKNOWN

  • SNC Graft Versus Host Disease

    collaborator UNKNOWN

  • Imagine Institute

    collaborator OTHER

  • Axonal-Biostatem

    collaborator INDUSTRY

  • CERBA laboratory

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Hermine, MD · Head of adult hematology department

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2023-03-16
Completion
2023-03-16

Countries

  • Belgium
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887156 on ClinicalTrials.gov