Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
NCT ID: NCT04852822
Last Updated: 2024-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
350 participants
OBSERVATIONAL
2021-03-18
2024-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (biospecimen collection, medical 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.
Biospecimen Collection
Undergo collection of blood samples
Electronic Health Record Review
Medical records are reviewed
Interventions
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Biospecimen Collection
Undergo collection of blood samples
Electronic Health Record Review
Medical records are reviewed
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CLL Global Research Foundation
UNKNOWN
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Chaitra S. Ujjani, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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City of Hope
Duarte, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
MedStar Georgetown University Hospital
Washington D.C., 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
Countries
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References
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Ujjani C, Gooley TA, Spurgeon SE, Stephens DM, Lai C, Broome CM, O'Brien S, Zhu H, Laing KJ, Winter AM, Pongas G, Greninger AL, Koelle DM, Siddiqi T, Davids MS, Rogers KA, Danilov AV, Sperling A, Tu B, Sorensen T, Launchbury K, Burrow CJ, Quezada G, Hill JA, Shadman M, Thompson PA. Diminished humoral and cellular responses to SARS-CoV-2 vaccines in patients with chronic lymphocytic leukemia. Blood Adv. 2023 Sep 12;7(17):4728-4737. doi: 10.1182/bloodadvances.2022009164.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2021-02178
Identifier Type: REGISTRY
Identifier Source: secondary_id
10646
Identifier Type: OTHER
Identifier Source: secondary_id
RG1121418
Identifier Type: -
Identifier Source: org_study_id
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