Status:
COMPLETED
Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies
Lead Sponsor:
Mayo Clinic
Conditions:
Monoclonal B-Cell Lymphocytosis
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
D1. Primary Objective: 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...
Eligibility Criteria
Inclusion
- Patients must not have received any prior COVID-19 vaccination
- 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
- Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to registration
- 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.
Key Trial Info
Start Date :
January 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT04748185
Start Date
January 28 2021
End Date
July 13 2022
Last Update
July 10 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55902