Evaluation of Human Immune Responses Vaccination in Patients With 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.
Conditions:
๐Ÿฆ  Chronic Lymphocytic Leukemia ๐Ÿฆ  Diffuse Large B-Cell Lymphoma ๐Ÿฆ  Follicular Lymphoma ๐Ÿฆ  Mantle Cell Lymphoma ๐Ÿฆ  Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
๐Ÿ—“๏ธ Study Start (Actual) 6 April 2018
๐Ÿ—“๏ธ Primary Completion (Estimated) 22 October 2024
โœ… Study Completion (Estimated) 22 October 2024
๐Ÿ‘ฅ Enrollment (Estimated) 200
๐Ÿ”ฌ Study Type OBSERVATIONAL
๐Ÿ“Š Phase N/A
Locations:
๐Ÿ“ Atlanta, Georgia, United States
๐Ÿ“ Atlanta, Georgia, United States

๐Ÿ“‹ Eligibility Criteria

Description

    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/ยตL
    • * 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 โ‰ฅ 38.0 C, systolic blood pressure โ‰ค 90 or \> 180 mmHg, pulse โ‰ค 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 April 2018
  • First Submitted that Met QC Criteria 16 April 2018
  • First Posted 18 April 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 February 2024
  • Last Update Posted 23 February 2024
  • Last Verified February 2024