RECRUITING

Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Conditions

Chronic Lymphocytic Leukemia Diffuse Large B-Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Quick Facts

Study Start:2018-04-06

Study Completion:2024-10-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03501576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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

Inclusion Criteria

Exclusion 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:
* 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.

* 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

Contacts and Locations

Study Contact

Andres Chang, MD, PhD

CONTACT

404-778-3942

andres.chang@emory.edu

Principal Investigator

Andres Chang, MD, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Andres Chang, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

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

Study Start Date2018-04-06

Study Completion Date2024-10-22

Study Record Updates

Study Start Date2018-04-06

Study Completion Date2024-10-22

Terms related to this study

Additional Relevant MeSH Terms

Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma