Chronic Lymphocytic LeukemiaNCT03501576
Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
An observational study of Chronic Lymphocytic Leukemia and Diffuse Large B-Cell Lymphoma, run by Emory University at 2 sites in United States.
Trial summary
This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
- What is being tested?
- Inactivated Influenza Vaccine
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2018to 26 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 20 patients per observation group
Who may be able to join
- Subjects with a diagnosis of lymphoma falling into the following categories:
- B-NHL who have received 1 cycle of chemotherapy
- B-NHL in complete remission and within 12 months after completion of chemotherapy
- Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month
- B-NHL in complete remission for over 12 months
- Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy
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- Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.
- Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:
- Hematology:
- Hemoglobin: 7.0-16.1 gm/dL
- Platelet count: 10-600/µL
- Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season *- Platelet count: 10-600/uL
- For cohort 1: Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season.
- For cohort 3: Subjects must have previously received at least 1 dose of SARS-CoV2 vaccine. Patients who have not receive a prior SARS-CoV2 vaccine will be eligible to enroll in cohort.
Who cannot join
- Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient
- Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study
- Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection
- Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine
- Have a history of Guillain-Barre syndrome (GBS)
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- Subjects who had or are suspected to have had an influenza infection in the current influenza season
- Subjects who, at screening, have abnormal vital signs and/or physical exam, including a temperature ≥ 38.0 C, systolic blood pressure ≤ 90 or > 180 mmHg, pulse ≤ 60 or > 130 beats per minute, new rash, signs of infection
- Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season
- Subjects enrolled in hospice or whose life expectancy is less than 6 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Michael Churnetski, 404-778-3703, michael.c.churnetski@emory.edu
Andres Chang, MD, PhD
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Mike Churnetski, 404-778-3703, michael.c.churnetski@emory.edu
Vanessa Smith, 404-778-2419, vanessa.smith@emory.edu
About this study
This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the seroprotection and seroconversion rates after influenza or SARS-CoV2 vaccination in patients with lymphoma receiving active treatment or in follow up observation.
SECONDARY OBJECTIVES:
- To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.
II. To investigate the longevity of viral-specific humoral immunity to influenza virus in patients with lymphoma receiving active treatment or in follow up observation.
III. To assess the timing and strength of the peak immune response to vaccination.
IV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.
OUTLINE:
Patients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0.
After completion of study treatment, patients are followed up at days 7, 28, 90, 180, and 365.
- Conditions
- Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Being tested
- Inactivated Influenza Vaccine
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Influenza VaccineBiological
Also called Fluzone Quadrivalent, Fluzone Quadrivalent Influenza Vaccine, Quadrivalent Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccine
Given seasonal inactivated influenza vaccine IM
| Study group | Role | What they receive |
|---|---|---|
| Inactivated Influenza Vaccine | Patients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine Receives: Biological: Inactivated Influenza Vaccine | |
| Qualifying subjects to receive a SARS-CoV2 vaccine. | Patients receive a SARS-CoV2 vaccine. | |
| Clinical Group Receiving SARS-CoV2 Booster Vaccines | Patients receive a SARS-CoV2 vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40
Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.
Measured: Up to 180 days after immunization
Percentage of subjects achieving seroconversion
Seroconversion is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer > 1:40 or a pre-vaccination HI titer > 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer (day 0, 28). Rates of seroconversion will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.
Measured: Up to 180 days after immunization
Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose.
Assessments will be performed at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 8 after second dose of vaccine, and days 90, 180, and 365.
Measured: Up to 365 days after immunization
Cohort 3: Efficacy (immune response) of COVID vaccines at least 7 days after each booster vaccine dose.
Assessments will be performed after each dose of SARS-CoV2 booster vaccine.
Measured: From baseline up to 365 days
Secondary outcomes (4)
Measurement of virus-specific serum antibody levels after vaccination
For serum antibody responses directed against the vaccine epitopes, endpoint IgG titers after vaccination at each time point will be determined.
Measured: Up to 180 days after immunization
Measurement of virus-specific plasmablasts (PBs) after influenza vaccination
PBs responses against influenza or SARS-CoV2 will be determined by direct ex vivo enzyme-linked immunospot (ELISPOT). Changes in the PB population will be measured to assess the timing and strength of the peak immune response to vaccination.
Measured: Up to 180 days after immunization
Measurement of virus-specific memory B-cells (MBCs) after vaccination
The frequency of hemagglutinin (HA)-specific immunoglobulin G (IgG)-secreting MBCs per total IgG-secreting cells after vaccination will be determined. Changes in the MBC population will be measured to assess the timing and strength of the peak immune response to vaccination.
Measured: Up to 180 days after immunization
Maximum fold rise in antibody titer
Hemagglutination inhibition assays will be used to assess the timing and strength of the peak immune response to vaccination.
Measured: Up to 180 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start6 Apr 2018
- Primary completion26 May 2027 (estimated)
- Study completion26 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Chang, Emory University
- Investigators
- Andres Chang, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501576
- Sponsor's protocol ID
- IRB00101067
- Other IDs
- NCI-2017-02313, Winship4236-17
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT03501576
- Acronym / sponsor ID
- IRB00101067
- Conditions
- Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 18 Apr 2018 (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.
This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.
Detailed description
PRIMARY OBJECTIVE:
- To determine the seroprotection and seroconversion rates after influenza or SARS-CoV2 vaccination in patients with lymphoma receiving active treatment or in follow up observation.
SECONDARY OBJECTIVES:
- To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.
II. To investigate the longevity of viral-specific humoral immunity to influenza virus in patients with lymphoma receiving active treatment or in follow up observation.
III. To assess the timing and strength of the peak immune response to vaccination.
IV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.
OUTLINE:
Patients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0.
After completion of study treatment, patients are followed up at days 7, 28, 90, 180, and 365.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactivated Influenza Vaccine | – | Biological: Inactivated Influenza VaccinePatients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine |
| Qualifying subjects to receive a SARS-CoV2 vaccine. | – | –Patients receive a SARS-CoV2 vaccine. |
| Clinical Group Receiving SARS-CoV2 Booster Vaccines | – | –Patients receive a SARS-CoV2 vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients per observation group
Key inclusion criteria (14 listed)
- Subjects with a diagnosis of lymphoma falling into the following categories:
- Subject capable of providing written or electronic informed consent prior to initiation of any study procedures; subjects able to understand and comply with planned study procedures and be available for all study visits.
- Hemoglobin: 7.0-16.1 gm/dL
- Platelet count: 10-600/µL
- Subjects who have not received the seasonal influenza vaccine in the current flu season and are not suspected to have had an influenza infection in the current flu season *- Platelet count: 10-600/uL
Key exclusion criteria (10 listed)
- Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient
- Have any medical disease or condition that, in the opinion of the site principal investigator is a contraindication to study participation; this includes any chronic medical condition, defined as persisting 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject?s successful completion of this study
- Have an acute illness, as determined by the site principal investigator within 72 hours prior to study vaccination; an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol and was not due to an influenza infection
- Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
- Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated Influenza VaccineAlso: Fluzone Quadrivalent, Fluzone Quadrivalent Influenza Vaccine, Quadrivalent Influenza Vaccine, Quadrivalent Inactivated Influenza VaccineGiven seasonal inactivated influenza vaccine IM | Biological | Inactivated Influenza Vaccine |
Primary outcome
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40
Time frame: Up to 180 days after immunization
Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.
Percentage of subjects achieving seroconversion
Time frame: Up to 180 days after immunization
Seroconversion is defined as the percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer > 1:40 or a pre-vaccination HI titer > 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer (day 0, 28). Rates of seroconversion will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.
Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose.
Time frame: Up to 365 days after immunization
Assessments will be performed at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 8 after second dose of vaccine, and days 90, 180, and 365.
Cohort 3: Efficacy (immune response) of COVID vaccines at least 7 days after each booster vaccine dose.
Time frame: From baseline up to 365 days
Assessments will be performed after each dose of SARS-CoV2 booster vaccine.
4 secondary outcomes
Measurement of virus-specific serum antibody levels after vaccination
Time frame: Up to 180 days after immunization
Measurement of virus-specific plasmablasts (PBs) after influenza vaccination
Time frame: Up to 180 days after immunization
Measurement of virus-specific memory B-cells (MBCs) after vaccination
Time frame: Up to 180 days after immunization
Maximum fold rise in antibody titer
Time frame: Up to 180 days after immunization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Andres Chang, MD, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Diffuse Large B-Cell Lymphoma, run by Emory University at 2 sites 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 14 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andres Chang, MD, PhD (404-778-3942, andres.chang@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40 (time frame: Up to 180 days after immunization). The study lists 4 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 6 Jul 2026.