Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how the immune system responds to the flu vaccine in people with lymphoma. It tracks antibodies (proteins that fight germs) and immune cells over time, and compares them with those in people without lymphoma.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have B-cell non-Hodgkin lymphoma (B-NHL) and have had 1 round of chemotherapy, or be in complete remission (no signs of cancer) after chemotherapy, either within or beyond 12 months.
- Or have chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) and have taken ibrutinib for at least 1 month.
- Or have aggressive peripheral T-cell lymphoma (PTCL), a fast-growing lymphoma, and have had 1 round of chemotherapy.
- Be able to give written or electronic consent, understand and follow study instructions, and attend all visits.
- Have hemoglobin (a protein in red blood cells) of 7.0–16.1 gm/dL and platelets (cells that help stop bleeding) of 10–600/µL, or have results the study doctor considers not medically important.
- Have not had this season’s flu vaccine or a known or suspected flu infection this season. The listing also states this rule specifically for group 1.
- For group 3, the listing says a prior COVID-19 vaccine dose is required, but also says people without a prior dose may enroll. Ask the study team to clarify.
Who can't join
- Have HIV infection or a history of Guillain-Barré syndrome, a condition that can cause nerve damage and muscle weakness.
- Have a medical condition that the study doctor believes makes the study unsafe or prevents you from following or finishing it.
- Have a short-term illness within 72 hours before the study vaccine. A nearly resolved illness may be allowed if it was not flu and the doctor approves.
- Have used steroids that affect the whole body for more than 3 months in the past year.
- Have an allergy to eggs, egg or chicken protein, or another ingredient in the study vaccine.
- Have had or may have had flu this season, or have already received this season’s flu vaccine.
- Have abnormal vital signs or exam findings at screening, including fever of 38°C or higher, top blood pressure number of 90 or lower or above 180, pulse of 60 or lower or above 130, a new rash, or signs of infection.
- Receive hospice care or be expected to live less than 6 months.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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) * 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
Study sites (2)
GA
- Emory University Hospital Midtown · Atlanta, GA 30308Michael Churnetski · Study contact · 404-778-3703 · michael.c.churnetski@emory.eduAndres Chang, MD, PhD · Principal investigatorMore trials in Atlanta
- Emory University Hospital/Winship Cancer Institute · Atlanta, GA 30322Mike Churnetski · Study contact · 404-778-3703 · michael.c.churnetski@emory.eduVanessa Smith · Study contact · 404-778-2419 · vanessa.smith@emory.eduMore trials in Atlanta