B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

Hematologic Malignancy Clinical Trial

— B-REC  

Official title:

B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04682314
• Other study ID #: APHP201015
• Status: Not yet recruiting
• Start date: December 2020
• Est. completion date: July 2023

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Gérard SOCIE
• Phone: 01-42-49-98-24
• Email: gerard.socie[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2023
• Est. primary completion date: March 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	B cells reconstitution	B cell clusters as assess by CyTOF technology	at day 100 days post-transplant
Secondary	B cells reconstitution	B cell clusters as assess by CyTOF technology	at 6 months post-transplant
Secondary	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
Secondary	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