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

Terminated

• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Interventions: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

• Registration Number: NCT04852822
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study Start: 2021-03-18
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Primary Completion: 2023-01-01
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (biospecimen collection, medical record review)	Electronic Health Record Review	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.
Observational (biospecimen collection, medical record review)	Biospecimen Collection	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.

Primary Outcome Measures

Name	Time	Method
Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma	Up to 2 years

Trial Locations

Locations (11)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

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

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

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States