Spots Global Cancer Trial Database for Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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Trial Identification
Brief Title: Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official Title: Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL
Study ID: NCT04852822
Study Description
Brief 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.
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, 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
Oregon Health & Sciences University, Portland, Oregon, United States
M D Anderson Cancer Center, Houston, Texas, 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
Contact Details
Name: Chaitra S. Ujjani, MD
Affiliation: Fred Hutch/University of Washington Cancer Consortium
Role: PRINCIPAL_INVESTIGATOR
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