B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation (B-REC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hematologic Malignancy

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Gérard SOCIE; Phone Number: 01-42-49-98-24; Email: gerard.socie@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cells reconstitution	B cell clusters as assess by CyTOF technology	at day 100 days post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B cells reconstitution	B cell clusters as assess by CyTOF technology	at 6 months post-transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells	Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology	at 100 days post transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells	Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology	at 6 months post-transplant

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: APHP201015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No