High-dose vs standard-dose flu vaccine in adults with blood cancers on B-cell-depleting therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center phase 2 randomized trial compares the humoral and cellular immune responses to high-dose versus standard-dose inactivated influenza vaccine in 60 adults with hematologic malignancies who recently received B-cell-depleting therapy. Participants are assigned 1:1 to receive one of the vaccines, with laboratory immunogenicity outcomes assessed in a blinded fashion while treatment teams know which vaccine was given. Humoral responses will be measured by hemagglutination inhibition, and cellular responses will be evaluated by intracellular cytokine staining of influenza-specific T cells. The primary setting is Asan Medical Center in Seoul, Korea, and the study uses blinded laboratory assessment to reduce bias in outcome measurement.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 19 years or older
* Confirmed diagnosis of hematologic malignancy
* Has received B-cell-depleting therapy (anti-CD20 antibody, bispecific antibody, or CAR-T cell therapy) within 2 years before vaccination
* Able and willing to provide written informed consent and comply with study procedures

Exclusion Criteria:

* Known hypersensitivity to influenza vaccine components
* Influenza vaccination within the preceding 6 months
* Difficulty with repeated venipuncture or blood sampling (e.g., poor vascular access or bleeding tendency)
* Cognitive or psychiatric impairment precluding understanding of or cooperation with study procedures
* Any other condition deemed clinically inappropriate for study participation at investigator discretion

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: So Yun Lim, MD, PhD
• Email: soyun_lim@amc.seoul.kr
• Phone: +82-2-3010-3303

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.