Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

  • STATUS
    Recruiting
  • End date
    Aug 8, 2022
  • participants needed
    500
  • sponsor
    University of Washington
Updated on 21 July 2021
cancer
chronic lymphocytic leukemia
lymphoma

Summary

This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer that begin in cells of the immune system. CLL/SLL and the medications used to treat these conditions may change the way vaccines work in a patient's body. The purpose of this study is to find out if patients with CLL/SLL make antibodies, or have an immune response, to the SARS-CoV-2 vaccines. Information gained from this study may help researchers better understand how effective the vaccines work in preventing COVID-19 (coronavirus disease 2019) in patients with CLL and SLL.

Description

OUTLINE

For patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed.

For patients enrolled after vaccination, they will undergo collection of blood samples at 1-4, 6, and 12 months after completing the vaccination series.

After completion of study, patients are followed up every 6 months for 2 years.

Details
Condition Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, b-cell small lymphocytic lymphoma
Treatment biospecimen collection, Electronic Health Record Review
Clinical Study IdentifierNCT04852822
SponsorUniversity of Washington
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >= 18 years
A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Exclusion Criteria

Any known history of prior SARS-CoV-2/COVID19 infection
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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