B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04682314

Acronym

B-REC

Enrollment

Registered

2020-12-23

Start date

2020-12-31

Completion date

2023-07-31

Last updated

2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
B cells reconstitution	at 6 months post-transplant	B cell clusters as assess by CyTOF technology
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

Contacts

Primary ContactGérard SOCIE

gerard.socie@aphp.fr01-42-49-98-24

Backup ContactMatthieu Resche-Rigon

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

Outcome results