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NCT04852822 Clinical Trial

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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04852822
Other study ID # RG1121418
Secondary ID NCI-2021-0217810
Status Active, not recruiting
Phase
First received
Last updated
Start date March 18, 2021
Est. completion date July 1, 2024

Study information
Verified date February 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. Patients who receive booster dose also undergo collection of blood samples at 1, 6, and 12 months post final booster dose. After completion of study, patients are followed up every 6 months for 2 years.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 345
Est. completion date July 1, 2024
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >= 18 years - A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) - Willing and able to participate in all required evaluations and procedures in this study Exclusion Criteria: - Any evidence of prior SARS-CoV-2/COVID19 infection

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood samples
Other:
• Electronic Health Record Review
Medical records are reviewed

Locations
Country Name City State
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States City of Hope Duarte California
United States M D Anderson Cancer Center Houston Texas
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Oregon Health & Sciences University Portland Oregon
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington
United States MedStar Georgetown University Hospital Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
University of Washington CLL Global Research Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma Up to 2 years
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