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Immunoregulatory T Lymphocytes Subtypes and Haematopoietic Stem Cell Transplantation (HSCT)

NCT02194868 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2025-11-20

No results posted yet for this study

Summary

The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality

Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies

Interventions

BIOLOGICAL

Recipients

1. Adult recipient: * collected 20 ml pre-transplant * collected 30 ml for adults on day 20 post-transplant at engraftment for cell phenotype, * collected 30 ml on days 30, 60, 90, 180, 360 days post-HSCT for cell phenotyping at all time points, functional INKT at day 60 or 90 depending on the number of cells collected and anti-viral ELISPOT studies on days 180 and 360 2. Children recipients * collected residual blood pre-transplant * collected residual blood on day 20 post-transplant at engraftment for cell phenotype, * collected residual blood on days 20, 30, 90, 180 and 360 post-HSCT

BIOLOGICAL

Donors

1. Adult donors : * collected 20 ml of blood, (if possible before granulocyte colony-stimulating factor (GCSF) administration) * collected 1 ml of the stem cell graft for adult recipient or 2 ml of bone marrow for children recipients These samples will be collected at the same time of those needed for transplant. 2. Children donors samples * collected residual blood * 2ml of bone marrow (bottom of tube)

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marie-Thérèse Rubio, MD, PhD · CHU NANCY

  • Olivier Hermine, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-02
Primary Completion
2022-01-18
Completion
2022-01-18

Countries

  • France

Study Locations

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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 NCT02194868 on ClinicalTrials.gov