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D1. Primary Objective:
1. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies
D2. Secondary Objectives:
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| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immunogenicity | Number of participants who have detectable antibodies to SARS-Co-V2 vaccination | Assessed 14 days following the second dose of the vaccine |
| Cellular Immunogenicity | Number of participants who have a SARS-CoV-2 specific memory B cell ELISPOT response | Assessed 14 days following the second dose of the vaccine |
| Cellular Immunogenicity | Number of participants who have a SARS-CoV-2 specific IFNγ ELISPOT T cell response | Assessed 14 days following the second dose of the vaccine |
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Inclusion Criteria:
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 Criteria:
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All patients will submit peripheral blood samples a) prior to first dose of vaccination; b) prior to receipt of the second dose of vaccination; c) 14 days following the second dose; and d) 3, 6 and 12 months following the first dose of the vaccination. For patients at time points a, b, and c blood samples can be collected up to 3 days prior; and at time point d +/- 10 days.
Patients who are seen at Mayo Clinic in Rochester, MN can collect their blood through a venipuncture at the clinic. For patients who are to receive vaccination locally, a blood kit will be mailed for the patients to get research bloods collected and sent to Mayo Clinic.
All patients will also complete a diary of adverse reactions (Appendix I) daily for 7 days after receipt of each dose of the vaccine. Patients will be asked to contact their primary care provider or hematologist if they have any side effects from the vaccination.
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| Name | Affiliation | Role |
|---|---|---|
| Sameer Parikh, M.B.B.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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There is no plan to make individual participant data (IPD) available
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D006689 | Hodgkin Disease |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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