Vaccine Responses in Patients With B Cell Malignancies
ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
About this trial
Background:
People 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.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM
If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
Age >= 18 years
Able to comprehend the investigational nature of the protocol and provide informed consent
Disqualifiers
Female patients who are currently pregnant
History of severe allergic reaction to vaccines
Concomitant inherited immunodeficiency
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Fluzone
Biological/VaccineAnnual Influenza Vaccine
Shingrix
Biological/VaccineRecombinant, adjuvanted Zoster Vaccine (RZV)
Flucelvax
Biological/VaccineAnnual Influenza Vaccine
Afluria
Biological/VaccineAnnual Influenza Vaccine
PREVNAR 13
Biological/VaccinePneumococcal Conjugate Vaccine (PCV13)
Heplisav -B
Biological/VaccineRecombinant, adjuvanted Hepatitis (HepB-CpG)
Pfizer-COVID-19 Vaccine
Biological/VaccineCOVID-19 Vaccine
FluLaval
Biological/VaccineAnnual Influenza Vaccine
Fluarix
Biological/VaccineAnnual Influenza Vaccine
PNEUMOVAX 23
Biological/VaccinePneumococcal Polysaccharide Vaccine (PPSV23)
PREVNAR 20
DrugPneumococcal 20-Valent Conjugate Vaccine (PCV20)
AREXVY, ABRYSVO
DrugRespiratory Syncytial Virus Vaccine
Treatment groups
350 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: Chronic Lymphocytic Leukemia Not Receiving Active TreatmentExperimental treatment 12 interventions
Group B: Chronic Lymphocytic Leukemia Treatment Break for BTKiExperimental treatment 12 interventions
Group C: Chronic Lymphocytic Leukemia Treatment NaiveExperimental treatment 12 interventions
Group D: Chronic Lymphocytic Leukemia Treatment with BTKiExperimental treatment 12 interventions
Group E: Follicular LymphomaExperimental treatment 12 interventions
Group F: Follicular Lymphoma Treatment NaiveExperimental treatment 12 interventions
Group G: Other Non-Hodgkin Lymphoma and Waldenstrom MacroglobulinemiaExperimental treatment 12 interventions
Group H: Other Non-Hodgkin Lymphoma and Waldenstrom Macroglobulinemia - Treatment with Targeted TherapiesExperimental treatment 12 interventions
Group I: Participants diagnosed with Chronic Lymphocytic Leukemia (CLL)Experimental treatment 12 interventions
Trial outcomes
Primary outcomes
1
Serologic response against each administered vaccine following completion of the vaccine series in each study arm
vaccine titer
Time frame
4 weeks after completing vaccine seriesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov