[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452353":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":68,"centralContacts":73,"locations":82,"responsibleParty":103,"collaborators":46,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":46,"eligibilityCriteria":110,"healthyVolunteers":107,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":46,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":85,"whyStopped":46,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,19,23,27,30,34,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Chronic Lymphocytic Leukemia (CLL) - Treatment with BCL-2 Inhibitor","EXPERIMENTAL","Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO, and receive assessment of serologic and cellular response following completion of each vaccine series.",[13,14,15,16,17,18],"Drug: AREXVY, ABRYSVO","Drug: PREVNAR 20","Biological: PNEUMOVAX 23","Biological: Heplisav -B","Biological: PREVNAR 13","Biological: Shingrix",{"label":20,"type":10,"description":21,"interventionNames":22},"Chronic Lymphocytic Leukemia Not Receiving Active Treatment","Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.",[13,14,15,16,17,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Chronic Lymphocytic Leukemia Treatment Break for BTKi","Participants may receive one or more of the following vaccine types: Shingrix, Heplisav -B, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.",[13,14,15,16,17,18],{"label":28,"type":10,"description":25,"interventionNames":29},"Chronic Lymphocytic Leukemia Treatment Naive",[13,14,15,16,17,18],{"label":31,"type":10,"description":32,"interventionNames":33},"Chronic Lymphocytic Leukemia Treatment with BTKi","Participants may receive one or more of the following vaccine types: Shingrix, PREVNAR 13, PNEUMOVAX 23, PREVNAR 20, AREXVY, ABRYSVO and receive assessment of serologic and cellular response following completion of each vaccine series.",[13,14,15,16,17],{"label":35,"type":10,"description":25,"interventionNames":36},"Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Not receiving active treatment",[13,14,15,16,17,18],{"label":38,"type":10,"description":11,"interventionNames":39},"Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted Therapies",[13,14,15,16,17,18],[41,47,51,56,60,64],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","AREXVY, ABRYSVO","Respiratory Syncytial Virus Vaccine",[9,20,24,28,31,35,38],null,{"type":42,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"PREVNAR 20","Pneumococcal 20-Valent Conjugate Vaccine (PCV20)",[9,20,24,28,31,35,38],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":46},"BIOLOGICAL","PNEUMOVAX 23","Pneumococcal Polysaccharide Vaccine (PPSV23)",[9,20,24,28,31,35,38],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":46},"Heplisav -B","Recombinant, adjuvanted Hepatitis (HepB-CpG)",[9,20,24,28,31,35,38],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":46},"PREVNAR 13","Pneumococcal Conjugate Vaccine (PCV13)",[9,20,24,28,31,35,38],{"type":52,"name":65,"description":66,"armGroupLabels":67,"otherNames":46},"Shingrix","Recombinant, adjuvanted Zoster Vaccine (RZV)",[9,20,24,28,35,38],[69],{"name":70,"affiliation":71,"role":72},"Adrian U Wiestner, M.D.","National Heart, Lung, and Blood Institute (NHLBI)","PRINCIPAL_INVESTIGATOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":46,"email":78},"Ingrid C Frey","CONTACT","(301) 402-0797","ingrid.frey@nih.gov",{"name":70,"role":76,"phone":80,"phoneExt":46,"email":81},"(301) 594-6855","wiestnera@mail.nih.gov",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-77.10026,38.98067,{"lat":95,"lon":94},[98],{"name":99,"role":76,"phone":100,"phoneExt":101,"email":102},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":104,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100452353","phase-4-vaccine-responses-in-patients-with-b-cell-malignancies-100452353",false,"NCT05170399","Vaccine Responses in Patients With B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM\n* Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:\n\n  1. Patients with CLL AND one of the following:\n\n     i. Arm 1: Must be treatment naive (no prior cancer directed therapy)\n\n     ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment\n\n     iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine\n\n     iv. Arm 4: Must be receiving treatment with a BTKi for \\>= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.\n\n     v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor\n\n     Or\n  2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:\n\n     i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)\n\n     ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)\n* If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response\n* Age \\>= 18 years\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1. Female patients who are currently pregnant\n2. History of severe allergic reaction to vaccines\n3. Concomitant inherited immunodeficiency\n4. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk.\n5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination\n6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination\n7. Receive anti-CD20 and\u002For anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination\n8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination\n9. History of allogeneic stem cell transplantation","ALL","18 Years","90 Years",{"count":115,"type":116},350,"ESTIMATED","INTERVENTIONAL",[119],"PHASE4","Background:\n\nPeople with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.\n\nObjective:\n\nTo learn how well vaccines work in people who have certain types of blood cancers.\n\nEligibility:\n\nAdults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.\n\nDesign:\n\nParticipants will get one or more vaccines for illnesses, such as vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses.\n\nParticipants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series.\n\nParticipants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response.\n\nParticipants will have pregnancy tests, if needed.\n\nParticipants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination.\n\nParticipants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional.\n\nParticipation will last for up to 5 years after each vaccine series is received.",[122],"Lymphoma",[124,125,126,122,127],"CLL","SLL","Booster","Vaccines","2026-08-01",{"date":130,"type":131},"2026-08-04","ACTUAL",{"date":133,"type":131},"2022-09-14",{"date":135,"type":116},"2036-11-15",{"name":71,"class":6},1]