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Minor2 versionsRe-verified since Sep 19, 2023, no change to tracked fieldsv189-v190
NotablePrimary completion date: Aug 9, 2023 to Aug 16, 2024v188
Minor7 versionsRe-verified since Nov 23, 2022, no change to tracked fieldsv181-v187
MinorEligibility criteria expanded, about 30 wordsv180
MinorStudy completion date: Aug 16, 2023 to Aug 16, 2024v179
MinorRe-verified, no change to tracked fieldsv178
MinorStart date changed from estimate of Sep 21, 2022 to Sep 14, 2022v177
MinorStart date: Sep 20, 2022 to Sep 21, 2022v176
MinorStart date: Sep 19, 2022 to Sep 20, 2022v175
MinorStart date: Sep 18, 2022 to Sep 19, 2022v174
MinorStart date: Sep 15, 2022 to Sep 18, 2022v173
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 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.
Participants 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.
Participants 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.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination.
Participants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.