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临床试验/NCT05587881
NCT05587881撤回不适用

Clinical Study on the Impact of Covid-19 Vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Sem Cell Transplantation

The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Disease-free Survival(PFS)

研究概览

简要总结

Aim of this study will evaluate the Impact of Covid-19 vaccine on Safety and Efficacy of Hematological Patients Received Allogeneic Hematopoietic Stem Cell Transplantation.

详细描述

Since the first detection of a Corona Virus Disease 2019 (COVID-19) infection in late 2019, the syndrome coronavirus-2 (SARS-CoV-2) has spread rapidly across the globe, threatening the health and safety of an increasing number of people. The development of the SARS-CoV-2 vaccine has been shown to be effective in reducing the chance of COVID-19 infection and the severity of the disease. To control the COVID-19 pandemic, an increasing number of studies are calling for people to receive the SARS-CoV-2 vaccine, and the Chinese government is also advocating universal vaccination. However, the investigators have found in our work that as vaccination has become more widespread, clinicians have become somewhat confused about whether they can choose someone who has been vaccinated against SARS-CoV-2 as a donor for a bone marrow transplant, and what is the optimal time for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in vaccined hematological patients. This study will evaluate the impact of Covid-19 vaccine on safety and efficacy of hematological patients received allo-HSCT.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Allogeneic hematopoietic stem cell transplantation is expected to start in the short term.
  • Able and willing to provide written informed consent and comply with all requirements for study participation (including all study procedures).

排除标准

  • Patients or donors with a history of previous infection with SARS-Cov-
  • Patients or donors are currently infected with SARS-Cov-
  • Patients have a history of other malignancies, disease progression, or is currently on systemic therapy.

结局指标

主要结局

Disease-free Survival(PFS)

时间窗: up to 12 months

To measure the duration of response to allo-HSCT over a follow-up period of 12 months.

次要结局

  • Adverse events profile(Measured 12 months after stem cells infused)
  • Overall Survival(OS)(up to 12 months)

研究者

发起方
The First Affiliated Hospital of Soochow University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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