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B-REC: B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04682314
Collaborator
(none)
60
Enrollment
30.9
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematological malignancies. However, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. To date, the design of new therapeutic strategies to improve immune recovery in allo-HSCT patients is still hampered by the fact that post-transplant regenerative hematopoiesis has never been studied, and more generally by our currently limited knowledge on the development and function of human B lymphocytes. The main objective of our study is to study early B-cell progenitor reconstitution after allogeneic hematopoietic stem cell transplantation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation
    Anticipated Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. B cells reconstitution [at day 100 days post-transplant]

      B cell clusters as assess by CyTOF technology

    Secondary Outcome Measures

    1. B cells reconstitution [at 6 months post-transplant]

      B cell clusters as assess by CyTOF technology

    2. Perturbations in growth or differentiation of progenitor/precursor of B cells [at 100 days post transplant]

      Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology

    3. Perturbations in growth or differentiation of progenitor/precursor of B cells [at 6 months post-transplant]

      Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    Patients :

    • 18 years of age and older

    • with hematological malignancies and subject to allogeneic HSCT

    • with health insurance coverage (bénéficiaire ou ayant droit)

    • having signed a written informed consent.

    Inclusion criteria of donor

    • 18 years of age and older

    • with health insurance coverage (bénéficiaire ou ayant droit)

    • having signed a specific written informed consent.

    Exclusion criteria of recipient and donor

    • Absence of written informed consent

    • Patient or donor on AME

    • Patient or donor on AME or under protection by law, tutorship or curatorship

    • Pregnant women

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04682314
    Other Study ID Numbers:
    • APHP201015
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Dec 23, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Dec 23, 2020