Actively Recruiting
Vaccine Responses in Patients With B Cell Malignancies
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-02-05
500
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vaccine Responses in Patients With B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphomas (MZL), non-Hodgkin lymphoma not otherwise specified (NHL NOS), or Waldenstrom macroglobulinemia (WM)
- For CLL patients: must be treatment naive, not receiving active treatment, receiving Bruton tyrosine kinase inhibitor (BTKi) treatment, willing to pause BTKi treatment for up to 7 weeks if eligible, or receiving BCL-2 inhibitor treatment
- For FL, MCL, MZL, NHL NOS, or WM patients: must not be receiving active treatment or must be receiving targeted therapies such as BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, or proteasome inhibitors
- If previously vaccinated for hepatitis B, must have documentation of a negative serologic response
- Age 18 years or older
- Able to understand the study and provide informed consent
You will not qualify if you...
- Currently pregnant female patients
- History of severe allergic reaction to vaccines
- Inherited immunodeficiency
- Any life-threatening illness or organ dysfunction that could risk safety or study outcomes
- Received cytotoxic chemotherapy within 2 weeks before vaccination
- Received intravenous immunoglobulin (IVIG) within 2 months before vaccination
- Received anti-CD20 or anti-CD19 monoclonal antibody therapy within 6 months before vaccination
- Received cellular therapy such as CAR-T cells within 12 months before vaccination
- History of allogeneic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
R
Rachel A Adams
CONTACT
A
Adrian U Wiestner, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
9
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