[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03501576":3,"trial-entities:NCT03501576":142,"trial-summary:NCT03501576":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":58,"sex":71,"minimum_age":72,"maximum_age":25,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":101,"locations":104,"central_contacts":134,"overall_officials":138,"references":140,"see_also_links":141},"NCT03501576","IRB00101067","Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma","RECRUITING","2028-05-26","2026-07","2026-07-06","2018-04-06","Emory University","OTHER",true,"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.","PRIMARY OBJECTIVE:\n\nI. To determine the seroprotection and seroconversion rates after influenza or SARS-CoV2 vaccination in patients with lymphoma receiving active treatment or in follow up observation.\n\nSECONDARY OBJECTIVES:\n\nI. To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.\n\nII. To investigate the longevity of viral-specific humoral immunity to influenza virus in patients with lymphoma receiving active treatment or in follow up observation.\n\nIII. To assess the timing and strength of the peak immune response to vaccination.\n\nIV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.\n\nOUTLINE:\n\nPatients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0.\n\nAfter completion of study treatment, patients are followed up at days 7, 28, 90, 180, and 365.",[18,19,20,21,22],"Chronic Lymphocytic Leukemia","Diffuse Large B-Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},200,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","Inactivated Influenza Vaccine","Given seasonal inactivated influenza vaccine IM",[33],[37,38,39,40,41],"Fluzone Quadrivalent","Fluzone Quadrivalent Influenza Vaccine","Quadrivalent Influenza Vaccine","Quadrivalent Inactivated Influenza Vaccine","Flu Vaccine",[43,47,50,54],{"measure":44,"description":45,"timeFrame":46},"Cohort 1: Percentage of subjects achieving seroprotection, defined as the percentage of subjects with a post-vaccination HI titer > 1:40","Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.","Up to 180 days after immunization",{"measure":48,"description":49,"timeFrame":46},"Percentage of subjects achieving seroconversion","Seroconversion is defined as the percentage of subjects with either a pre-vaccination HI titer \\\u003C 1:10 and a post-vaccination HI titer \\> 1:40 or a pre-vaccination HI titer \\> 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer (day 0, 28). Rates of seroconversion will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.",{"measure":51,"description":52,"timeFrame":53},"Cohort 2: Efficacy (immune response of COVID vaccines at least 7 days after the second dose.","Assessments will be performed 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.","Up to 365 days after immunization",{"measure":55,"description":56,"timeFrame":57},"Cohort 3: Efficacy (immune response) of COVID vaccines at least 7 days after each booster vaccine dose.","Assessments will be performed after each dose of SARS-CoV2 booster vaccine.","From baseline up to 365 days",[59,62,65,68],{"measure":60,"description":61,"timeFrame":46},"Measurement of virus-specific serum antibody levels after vaccination","For serum antibody responses directed against the vaccine epitopes, endpoint IgG titers after vaccination at each time point will be determined.",{"measure":63,"description":64,"timeFrame":46},"Measurement of virus-specific plasmablasts (PBs) after influenza vaccination","PBs responses against influenza or SARS-CoV2 will be determined by direct ex vivo enzyme-linked immunospot (ELISPOT). Changes in the PB population will be measured to assess the timing and strength of the peak immune response to vaccination.",{"measure":66,"description":67,"timeFrame":46},"Measurement of virus-specific memory B-cells (MBCs) after vaccination","The frequency of hemagglutinin (HA)-specific immunoglobulin G (IgG)-secreting MBCs per total IgG-secreting cells after vaccination will be determined. Changes in the MBC population will be measured to assess the timing and strength of the peak immune response to vaccination.",{"measure":69,"description":70,"timeFrame":46},"Maximum fold rise in antibody titer","Hemagglutination inhibition assays will be used to assess the timing and strength of the peak immune response to vaccination.","ALL","18 Years",false,{"inclusion":75,"exclusion":89,"raw_text":100},[76,77,78,79,80,81,82,83,84,85,86,87,88],"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\u002FdL","Platelet count: 10-600\u002FµL","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\u002FuL","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.",[90,91,92,93,94,95,96,97,98,99],"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\u002For 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:\n\n* Subjects with a diagnosis of lymphoma falling into the following categories:\n\n  * B-NHL who have received 1 cycle of chemotherapy\n  * B-NHL in complete remission and within 12 months after completion of chemotherapy\n  * Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month\n  * B-NHL in complete remission for over 12 months\n  * Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy\n* 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.\n\n  * Screening labs must be within the following ranges or considered to be not clinically significant by the investigator:\n\nHematology:\n\n* Hemoglobin: 7.0-16.1 gm\u002FdL\n* Platelet count: 10-600\u002FµL\n* 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\u002FuL\n\n  * 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.\n  * 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.\n\nExclusion Criteria:\n\n* Known infection with human immunodeficiency virus (HIV). This information will be obtained verbally from the patient\n* 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\n* 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\n* Subjects taking long-term systemic steroids defined as greater than 3 months in the past 12 months\n* Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the study vaccine\n* Have a history of Guillain-Barre syndrome (GBS)\n* Subjects who had or are suspected to have had an influenza infection in the current influenza season\n* Subjects who, at screening, have abnormal vital signs and\u002For 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\n* Subjects who have already received the seasonal influenza vaccine in the current influenza vaccination season\n* Subjects enrolled in hospice or whose life expectancy is less than 6 months",[102,103],"ADULT","OLDER_ADULT",[105,123],{"facility":106,"status":7,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":120},"Emory University Hospital Midtown","Atlanta","Georgia","30308","United States",[112,117],{"name":113,"role":114,"phone":115,"email":116},"Michael Churnetski","CONTACT","404-778-3703","michael.c.churnetski@emory.edu",{"name":118,"role":119},"Andres Chang, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},33.749,-84.38798,{"facility":124,"status":7,"city":107,"state":108,"zip":125,"country":110,"contacts":126,"geoPoint":133},"Emory University Hospital\u002FWinship Cancer Institute","30322",[127,129],{"name":128,"role":114,"phone":115,"email":116},"Mike Churnetski",{"name":130,"role":114,"phone":131,"email":132},"Vanessa Smith","404-778-2419","vanessa.smith@emory.edu",{"lat":121,"lon":122},[135],{"name":118,"role":114,"phone":136,"email":137},"404-778-3942","andres.chang@emory.edu",[139],{"name":118,"affiliation":12,"role":119},[],[],{"nct_id":4,"conditions":143,"biomarkers":144},[18,19,20,21,22],[],{"nct_id":4,"found":14,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It aims to enroll 200 participants.","completed","Observational Study of Immune Response to Vaccination in Lymphoma Patients","This observational study is looking at how well people with lymphoma respond to vaccines, specifically the seasonal inactivated influenza vaccine. Researchers want to understand how your immune system (your body's defense against illness) reacts to these vaccines while you are being treated for lymphoma or after your treatment. They will measure antibody levels, which are proteins your immune system makes to fight off infections. This study includes people with various types of lymphoma, such as Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma. The goal is to see how well your body builds protection after vaccination. The study aims to enroll 200 participants, but its current status is unclear.","Participants will be followed for up to 365 days after immunization to assess immune responses.",110,"You would receive the seasonal inactivated influenza vaccine. After vaccination, you would have follow-up visits at days 7, 28, 90, 180, and 365.","Not stated in the trial record.",[33],"v2"]