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临床试验/NCT05088941
NCT05088941已完成不适用

Impact of SARS-CoV-2 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)

研究概览

简要总结

the SARS-CoV2 pandemic has led to a major reorganization of the French Hematology and stem cell transplant departments since march 2020. Since the allogeneic stem cell transplant cannot be delayed especially when patients with hematological malignancies are in a fragile remission, risking relapse at any time, the necessity to maintain safe hematopoietic stem cell (HSC) donations from match unrelated or family donors appears rapidly mandatory during the pandemic period. To increase the safety of voluntary donations, a SARS-CoV2 Polymerase Chain Reaction test has been recommended to donors by regulatory agencies. However, due to the lack of homogeneity of care at European level, some countries do not require SARS-CoV-2 testing in asymptomatic donors. In this case, the test is performed on additional EDTA tube accompanying the graft on arrival or in the case of a missing tube (not collected or forgotten), on few milliliters of the HSC graft. This circuit had the consequence of forcing the clinicians to wait for the test result before starting the patient's conditioning regimen. The graft being already collected and received at the transplant center, and the conditioning regimen lasting on an average of 5 days, this resulted in its conservation during this minimum period and therefore its freezing by the associated cell therapy unit. However, this practice has so far been exceptional regarding allogeneic transplants, which are primarily freshly infused to ensure to the recipient the highest viability and functionality of stem cells. Since the entire freezing-thawing and washing process may impact cell viability and delay the patient's aplastic recovery, this study aimed to analyze the results of one year of allogeneic transplants infused after freezing in terms of graft quality after thawing and clinical consequences.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients receiving an allogeneic stem cell transplant between march 2020 and may 2021.

排除标准

  • patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.

结局指标

主要结局

% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)

时间窗: 2020-2021

% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)

时间窗: 2020-2021

% of post-thaw CD34 viability

时间窗: 2020-2021

% of post-thaw TNC viability

时间窗: 2020-2021

%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)

时间窗: 2020-2021

次要结局

  • GvHD incidence(2020-2021)
  • death rate(2020-2021)
  • graft rejection(2020-2021)
  • infections rate(2020-2021)
  • relapse rate(2020-2021)
  • aplastic recovery(2020-2021)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

DECOT Véronique

professor

Central Hospital, Nancy, France

研究点 (1)

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