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临床试验/NCT04682314
NCT04682314Unknown不适用

B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 60 人开始时间: 2020年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
B cells reconstitution

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

B cells reconstitution

时间窗: at day 100 days post-transplant

B cell clusters as assess by CyTOF technology

次要结局

  • Perturbations in growth or differentiation of progenitor/precursor of B cells(at 6 months post-transplant)
  • B cells reconstitution(at 6 months post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

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