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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04852822
Enrollment
350
Registered
2021-04-21
Start date
2021-03-18
Completion date
2024-07-01
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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.

Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

OTHERElectronic Health Record Review

Medical records are reviewed

Sponsors

CLL Global Research Foundation
CollaboratorUNKNOWN
University of Washington
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphomaUp to 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026