Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Key facts
- Who runs it
- University of Washington
- Where
- Boston, Cleveland, Columbus, Duarte, Houston, Miami, Orange, Portland, Salt Lake City, Seattle, and Washington D.C., United StatesSee the 11 sites
- Trial code
- Status
- Terminated
- People taking part
- 350 people enrolled
- Started
- 18 Mar 2021
- Ended
- 1 Jul 2024
- Type of study
- Observational
- Treatments tested
- Biospecimen Collection
- Electronic Health Record Review
- Record updated
- 2 August 2024
- Why it stopped
- The study ended earlier than anticipated due to slow accrual.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any evidence of prior SARS-CoV-2/COVID19 infection
Where in United States
- Dana-Farber Cancer InstituteBoston, United States
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, United States
- Ohio State University Comprehensive Cancer CenterColumbus, United States
- City of HopeDuarte, United States
- M D Anderson Cancer CenterHouston, United States
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United States
- UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United States
- Oregon Health Sciences UniversityPortland, United States
- Huntsman Cancer Institute/University of UtahSalt Lake City, United States
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, United States
- MedStar Georgetown University HospitalWashington D.C., United States
About the trial
What the trial wants to find out
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.
The group in the trial
- 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.
Treatment: Biospecimen Collection and Electronic Health Record Review
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL
- Record updated
- 2 August 2024