Immunogenicity And Safety Of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) In Patients With Hematologic Malignancies And Associated Precursors

Overview

About this study

The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.

Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Patients must not have received any prior COVID-19 vaccination.
Patients must have any one of the following diagnosis:
- Monoclonal B-cell lymphocytosis;
- Chronic lymphocytic leukemia/small lymphocytic lymphoma.
- B-cell Non-Hodgkin’s lymphoma:
  - Follicular lymphom;
  - Mantle cell lymphoma;
  - Diffuse large B-cell lymphoma;
  - Marginal zone lymphoma;
  - Burkitt lymphoma;
  - Double hit/triple hit lymphoma;
  - Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia.
Hodgkin lymphoma.

Exclusion Criteria:

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Sameer Parikh, M.B.B.S.	Closed for enrollment	Contact information: McKenzie Kline 5072849597 kline.mckenzie@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sameer Parikh, M.B.B.S.

Closed for enrollment

Contact information:

McKenzie Kline

5072849597

kline.mckenzie@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials