Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
NCT05170399

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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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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