B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

NCT04682314 | Unknown

• 1 other identifier: APHP201015
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• B cells reconstitution

  B cell clusters as assess by CyTOF technology

  at day 100 days post-transplant

Secondary Outcomes (3)

• B cells reconstitution

  at 6 months post-transplant

• 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

  at 6 months post-transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years and older with hematological malignancies and subject to allogeneic HSCT

You may qualify if:

• Patients :
• 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.
• years of age and older
• with health insurance coverage (bénéficiaire ou ayant droit)
• having signed a specific written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Gérard SOCIE

CONTACT

01-42-49-98-24; gerard.socie@aphp.fr

Matthieu Resche-Rigon

CONTACT

+33142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 23, 2020
• Study Start: December 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 23, 2020

Record last verified: 2020-12