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NCT05170399 · ClinicalTrials.gov registry record · Phase 4
Vaccine Responses in Patients With B Cell Malignancies
A Phase 4 study of Lymphoma, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT05170399: Recruiting Phase 4 study of Lymphoma, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05170399 is a Phase 4 study of Lymphoma that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 500 participants, roughly in line with the 482-participant average among 299 other Lymphoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05170399, a Phase 4 study of Lymphoma, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
vaccine titer
Conditions Studied
Interventions
- BIOLOGICAL Shingrix
- BIOLOGICAL Fluzone
- BIOLOGICAL Flucelvax
- BIOLOGICAL Afluria
- BIOLOGICAL PREVNAR 13
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2026-08-16 |
| Phase | Phase 4 |
What NCT05170399 shows while recruiting
NCT05170399 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 482-participant average among 299 other Lymphoma trials with a reported enrollment target.
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Shingrix is the first listed.
NCT05170399 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05170399 about?
NCT05170399 is a clinical study titled "Vaccine Responses in Patients With B Cell Malignancies". 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 ...
What is the current status of trial NCT05170399?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2022-09-14. Estimated completion is 2026-08-16.
What conditions does trial NCT05170399 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT05170399?
The interventions under investigation include: Shingrix (BIOLOGICAL), Fluzone (BIOLOGICAL), Flucelvax (BIOLOGICAL), Afluria (BIOLOGICAL), PREVNAR 13 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05170399?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05170399 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05170399's enrollment target sits among peer trials
500 16th of 299 higher than 282 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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