Evaluating immune responses to influenza vaccination in lymphoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses how patients with various types of lymphoma respond to the influenza vaccine by measuring immune responses over time. The primary objective is to determine the rates of seroprotection and seroconversion after vaccination in patients undergoing treatment or in follow-up observation. Secondary objectives include characterizing specific immune cells and evaluating the longevity of the immune response. Patients will receive the inactivated influenza vaccine and will be monitored for immune response at multiple time points following vaccination.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University Hospital Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Andres Chang, MD, PhD — Emory University
• Study coordinator: Andres Chang, MD, PhD
• Email: andres.chang@emory.edu
• Phone: 404-778-3942

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.