Monoclonal B-Cell LymphocytosisNCT04748185
Immunogenicity and Safety of Commercially Available Vaccines Against SARS-CoV-2 (COVID-19) in Patients With Hematologic Malignancies
An observational study of Monoclonal B-Cell Lymphocytosis and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Mayo Clinic at 1 site in United States.
Trial 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 COVID-19 vaccination in patients with hematologic malignancies 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, B-cell Non Hodgkin Lymphoma
- How many people
- 358 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 13 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients must not have received any prior COVID-19 vaccination
- Patients must have any one of the following diagnosis:
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Hematologic Malignancies and Associated Precursor Conditions
D1. Primary Objective:
- Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies
D2. Secondary Objectives:
- 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
- Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
- Conditions
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, B-cell Non Hodgkin Lymphoma, Hodgkin Lymphoma
- Keywords
- Lymphoma, Covid-19 Vaccine, CLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Hodgkin Disease, Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral Immunogenicity
Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
Measured: 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
Measured: 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
Measured: Assessed 14 days following the second dose of the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start28 Jan 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal B-Cell LymphocytosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameer Parikh, M.B.B.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748185
- Sponsor's protocol ID
- 20-012589
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2021
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Hematologic Malignancies and Associated Precursor Conditions
- ClinicalTrials.gov ID
- NCT04748185
- Acronym / sponsor ID
- 20-012589
- Conditions
- Monoclonal B-Cell Lymphocytosis, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, B-cell Non Hodgkin Lymphoma, Hodgkin Lymphoma
- Keywords
- Lymphoma, Covid-19 Vaccine, CLL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
D1. Primary Objective:
- Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies
D2. Secondary Objectives:
- 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
- Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Patients must not have received any prior COVID-19 vaccination
- Patients must have any one of the following diagnosis:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Humoral Immunogenicity
Time frame: Assessed 14 days following the second dose of the vaccine
Number of participants who have detectable antibodies to SARS-Co-V2 vaccination
Cellular Immunogenicity
Time frame: Assessed 14 days following the second dose of the vaccine
Number of participants who have a SARS-CoV-2 specific memory B cell ELISPOT response
Cellular Immunogenicity
Time frame: Assessed 14 days following the second dose of the vaccine
Number of participants who have a SARS-CoV-2 specific IFNγ ELISPOT T cell response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameer Parikh, M.B.B.S. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal B-Cell Lymphocytosis and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral Immunogenicity (time frame: Assessed 14 days following the second dose of the vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.