Vaccine protection after blinatumomab in children with B-ALL
Official title: Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
Run by Arkansas Children's Hospital Research Institute · NCT07422337 · Data updated 2026-11-12
This project will see if children and young adults (ages 1–21) with B-cell acute lymphoblastic leukemia who received blinatumomab keep protective immunity from routine childhood vaccines and whether revaccination restores immunity when levels are low.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 23 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Drugs / interventions | blinatumomab, immunotherapy, CAR T, chemotherapy |
| Locations | 2 sites (Little Rock, Arkansas and 1 other locations) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | January 2028 |
| Study ends | January 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07422337 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and young adults aged 1 to 21 with B-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma who completed routine infant vaccinations, are not relapsed/refractory, and have not received nor require bone marrow transplant or other cellular therapy.
✕Probably not a fit
Patients with relapsed or refractory disease, those who have received or will require bone marrow transplant or other cellular therapies, pregnant patients, or those without documented routine infant vaccinations are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multi-site project measures antibody levels to routine childhood vaccines in pediatric and young adult patients with B-cell acute lymphoblastic leukemia who have been treated with blinatumomab. Participants with non-protective antibody titers will be offered revaccination and retested to determine whether humoral immunity is restored. Results from blinatumomab-treated participants will be compared with participants who received other chemotherapy but not blinatumomab to understand the specific impact of CD19-targeted immunotherapy. The data aim to inform practical revaccination timing and protocols for this vulnerable population.
Why it matters
Potential benefit: If successful, the findings could guide when and how to revaccinate children after blinatumomab to reduce their risk of vaccine-preventable infections.
How similar studies have gone: Prior work with B-cell–targeting therapies such as rituximab has shown reduced vaccine antibody levels and that revaccination can restore immunity in many cases, but data specifically on pediatric blinatumomab recipients remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of B-lineage acute lymphoblastic leukemia/lymphoma * ≥1 year old and up to 21 years old at diagnosis * Informed consent provided, and if applicable, child assent provided * Must have received all vaccinations routinely administered during first year of life Exclusion Criteria: * Relapsed/refractory disease at any time * Received or will require a bone marrow transplant and/or cellular therapy * Pregnancy
Where it's running
-
Arkansas Children's
Little Rock, Arkansas, United States Recruiting -
Arkansas Children's Northwest
Springdale, Arkansas, United States Recruiting
Study contacts
- Principal investigator: Lauren Appell, MD — Arkansas Children's Research Institute
- Study coordinator: Lauren Appell, MD
- Email: leappell@uams.edu
- Phone: 501-364-1494
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.