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Immunogenicity of COVID-19 Vaccination in Autologous HSCT or CAR-T Cells Recipients

Recruiting
18 years of age
Both
Phase N/A

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Overview

This multicenter, prospective, non-interventional cohort study aims to evaluate data on humoral and cellular immune response generated within the COVID-19 vaccination standard in patients with B-cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who underwent autologous hematopoietic stem cell transplantation (HSCT) or who were treated with or chimeric-antigen-receptor-T-cells (CAR-T).

Description

According to the COVID-19 vaccination standard, patients who underwent autologous HSCT or CAR-T cells receive between 3 to 8 anti-SARS-CoV-2 mRNA vaccination in 28-day intervals. The definitive number of vaccinations patients will receive depend on the individual neutralizing antibody response.

This study aims to analyze the immune response data generated within the procedures of the standard-of-care COVID-19 vaccination. Additional blood will be drawn from the patients at each visit defined within the vaccination standard by using the same vein puncture as used for blood drawings of routine blood samples. Study related blood samples will be used for evaluation of T and B cell response to COVID-19 vaccinations.

For this study, no additional visits or invasive procedures will be performed in addition to the standard interventions.

Eligibility

Inclusion Criteria:

  • Patient 42 days (±3) post autologous HSCT or CAR-T cell treatment for B-cell non-Hodgkin lymphoma or Hodgkin lymphoma.
  • Patient is 18 years of age or older at enrollment
  • Patients are eligible for study inclusion with or without confirmed SARS-CoV-2 infection prior to autologous HSCT/CAR-T cell treatment.
  • Patient is treated at an institution that practices the standard-of-care COVID-19 vaccination
  • Patient planned to be vaccinated against COVID-19 according to the hospital standard
  • Written informed consent from patient has been obtained prior to any study related procedures

Exclusion criteria:

  • Patient with confirmed SARS-CoV-2 infection between d0 and d42 after autologous HSCT or CAR-T cell treatment.
  • Patient has a positive SARS-CoV-2 antigen test at visit d42

Study details

COVID-19, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Adult

NCT05597761

Oliver Cornely, MD

17 April 2024

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