Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Who is this study for? Patients with lymphoma
What treatments are being studied? Inactivated Influenza Vaccine
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Contact Information
Primary
Andres Chang, MD, PhD
andres.chang@emory.edu
404-778-3942
Time Frame
Start Date: 2018-04-06
Estimated Completion Date: 2026-05-26
Participants
Target number of participants: 200
Treatments
Inactivated Influenza Vaccine
Patients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine
Qualifying subjects to receive a SARS-CoV2 vaccine.
Patients receive a SARS-CoV2 vaccine.
Clinical Group Receiving SARS-CoV2 Booster Vaccines
Patients receive a SARS-CoV2 vaccine.
Sponsors
Leads: Emory University

This content was sourced from clinicaltrials.gov