Study Stopped
The study ended earlier than anticipated due to slow accrual.
Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL
3 other identifiers
observational
350
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2021
CompletedFirst Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedAugust 2, 2024
July 1, 2024
1.8 years
April 19, 2021
July 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma
Up to 2 years
Study Arms (1)
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.
Interventions
Undergo collection of blood samples
Medical records are reviewed
Eligibility Criteria
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who receive a SARS-CoV-2 vaccine
You may qualify if:
- 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
You may not qualify if:
- Any evidence of prior SARS-CoV-2/COVID19 infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- CLL Global Research Foundationcollaborator
Study Sites (11)
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 D.C., 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
Related Publications (1)
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.
PMID: 36516082DERIVED
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaitra S. Ujjani, MD
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2021
First Posted
April 21, 2021
Study Start
March 18, 2021
Primary Completion
January 1, 2023
Study Completion
July 1, 2024
Last Updated
August 2, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share