Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies
NCT ID: NCT04748185
Last Updated: 2023-07-10
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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COMPLETED
358 participants
OBSERVATIONAL
2021-01-28
2022-07-13
Brief Summary
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1\. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies
D2. Secondary Objectives:
1. Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies
2. Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination
3. Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA
4. Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patients must have any one of the following diagnosis:
a. Monoclonal B-cell lymphocytosis b. Chronic lymphocytic leukemia/small lymphocytic lymphoma c. B-cell Non-Hodgkin's lymphoma: i. Follicular lymphoma ii. Mantle cell lymphoma iii. Diffuse large B-cell lymphoma iv. Marginal zone lymphoma v. Burkitt lymphoma vi. Double hit/triple hit lymphoma vii. Lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia d. Hodgkin lymphoma
Exclusion Criteria
2. Prior chemotherapy, immunotherapy or oral agent therapy that was completed \>12 months prior to enrollment. NOTE: patients who are on oral agents for the treatment of their underlying malignancy will be allowed. Some of these medication classes include Bruton tyrosine kinase inhibitor (BTKi), BCL2 antagonists, PI3 kinase inhibitors, immunomodulatory agents, among others. Please contact the Principal Investigator for any clarification about these medications.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Sameer Parikh, M.B.B.S.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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20-012589
Identifier Type: -
Identifier Source: org_study_id
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