RECRUITING

Vaccine Responses in Patients With B Cell Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vaccine Responses in Patients With B Cell Malignancies

Quick Facts

Study Start:2022-09-14
Study Completion:2025-08-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05170399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM
  2. * Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:
  3. 1. Patients with CLL AND one of the following:
  4. 2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:
  5. * If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response
  6. * Age \>= 18 years
  7. * Able to comprehend the investigational nature of the protocol and provide informed consent
  1. 1. Female patients who are currently pregnant
  2. 2. History of severe allergic reaction to vaccines
  3. 3. Concomitant inherited immunodeficiency
  4. 4. 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.
  5. 5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination
  6. 6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination
  7. 7. Receive anti-CD20 and/or anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination
  8. 8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination
  9. 9. History of allogeneic stem cell transplantation

Contacts and Locations

Study Contact

Shellin Jose
CONTACT
(301) 529-7119
shellin.jose@nih.gov
Christopher MT Pleyer, M.D.
CONTACT
(510) 709-6649
christopher.pleyer@nih.gov

Principal Investigator

Christopher MT Pleyer, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Christopher MT Pleyer, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-14
Study Completion Date2025-08-16

Study Record Updates

Study Start Date2022-09-14
Study Completion Date2025-08-16

Terms related to this study

Keywords Provided by Researchers

  • CLL
  • SLL
  • Booster
  • Lymphoma
  • Vaccines

Additional Relevant MeSH Terms

  • Lymphoma