Chronic Lymphocytic Leukemia Clinical Trial

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

Summary

This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with leukemia-cll/" >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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

345

Study ID:

NCT04852822

Recruitment Status:

Active, not recruiting

Sponsor:

University of Washington

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There are 11 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Oregon Health & Sciences University
Portland Oregon, 97239, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

345

Study ID:

NCT04852822

Recruitment Status:

Active, not recruiting

Sponsor:


University of Washington

How clear is this clinincal trial information?

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