B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

• Conditions: Hematologic Malignancy

• Registration Number: NCT04682314
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-18
• Last Update Submitted: 2020-12-18
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Primary Completion: 2023-03
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
B cells reconstitution	at day 100 days post-transplant	B cell clusters as assess by CyTOF technology

Secondary Outcome Measures

Name	Time	Method
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
B cells reconstitution	at 6 months post-transplant	B cell clusters as assess by CyTOF technology