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临床试验/EUCTR2021-001107-33-NL
EUCTR2021-001107-33-NL进行中(未招募)1 期

SARS-CoV-2 vaccination response in patients with haematologicaldisease - CovVhaem

MUMC0 个研究点目标入组 743 人开始时间: 2021年3月10日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
MUMC
入组人数
743

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • all of the following
  • Currently treated, previously treated and non-treated patients
  • diagnosed with a hematological malignancy (defined as: multiple myeloma (including MGUS) chronic lymphocytic leukemia, chronic myeloid leukemia, acute myeloid leukemia, acute lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, myelodysplastic syndrome, myeloproliferative disease).
  • Previously treated patient is defined as: treatment < 6 months before vaccination in patients that obtained a complete remission. Exceptions (no time restriction for last treatment) are patients with palliative treatment for ongoing haematological malignancies and patients after autologous and allogeneic stem cell transplantation.
  • Patients who are scheduled for and will undergo SARS-CoV-2
  • vaccination.
  • Aged = 18 years.
  • Written informed consent.
  • Inclusion is irrespective of previously proven or possible (based on
  • symptoms) COVID-19
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 446
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 288

排除标准

  • excluded from participation in this study:
  • Patients previously vaccinated for SARS-CoV-2.
  • Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
  • Any psychological, familial, sociological or geographical condition
  • potentially hampering compliance with the study protocol.

研究者

发起方
MUMC

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