Vaccine protection after blinatumomab in children with B-ALL
Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 1 Year to 23 Years |
| Sex | All |
| 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) |
| Trial ID | NCT07422337 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Little Rock, Arkansas and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.