Evaluation of Human Immune Responses to Vaccination in Patients with Lymphoma
Hematopoietic Malignancies
Leukemia
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
Winship4236-17 (primary)
NCI-2017-02313
IRB00101067
Summary
This study evaluates the effect of vaccination on 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.
Objectives
PRIMARY OBJECTIVE:
I. To determine the seroprotection and seroconversion rates after influenza or severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination in patients with lymphoma receiving active treatment or in follow up observation.
SECONDARY OBJECTIVES:
I. To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.
II. To investigate the longevity of virus-specific humoral immunity in patients with lymphoma receiving active treatment or in follow up observation.
III. To assess the timing and strength of the peak immune response to vaccination.
IV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1: Patients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0. Patients undergo collection of blood samples at baseline, and 7, 14, 28, 90, and 180 days after vaccination.
COHORT 2: Patients receive SARS-CoV-2 vaccine per standard of care. Patients undergo collection of blood samples at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 8 after second dose of vaccine, and days 90, 180, and 365.
Eligibility
- Subjects 18 years of age or above with a diagnosis of lymphoma falling into the following categories:
* B-cell non-Hodgkin lymphoma (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 Mature T-Cell and NK-Cell Non-Hodgkin 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
- Hemoglobin: 7.0-16.1 gm/dL
- Platelet count: 10-600/uL
- 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
- 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 2
Treatment Sites in Georgia
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