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Official Title
Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
Sponsor
Emory University
Enrollment
200
Timeline
Apr 2018 → May 2026
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.
Eligibility Criteria
Inclusion Criteria
- 1Subjects with a diagnosis of lymphoma falling into the following categories:
- 2B-NHL who have received 1 cycle of chemotherapy
- 3B-NHL in complete remission and within 12 months after completion of chemotherapy
- 4Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month
- 5B-NHL in complete remission for over 12 months
- 6Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy
- 7Subject 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.
- 8Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:
- 9Hematology:
- 10Hemoglobin: 7.0-16.1 gm/dL
- 11Platelet count: 10-600/µL
- 12Subjects 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
- 13For 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.
- 14For 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
- 1Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient
- 2Have 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
- 3Have 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
- 4Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months
- 5Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine
- 6Have a history of Guillain-Barre syndrome (GBS)
- 7Subjects who had or are suspected to have had an influenza infection in the current influenza season
- 8Subjects 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
- 9Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season
- 10Subjects enrolled in hospice or whose life expectancy is less than 6 months
Locations
2 sites participating in this study
Emory University Hospital Midtown
Atlanta, Georgia 30308
Andres Chang, MD, PhD
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Mike Churnetski
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →