NCT07422337 A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
| NCT ID | NCT07422337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | B-Cell ALL |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-13 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. The main study aims are: * Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL/Ly who have received blinatumomab. * To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity. Researchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.
Eligibility 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
Contact & Investigator
Lauren Appell, MD
PRINCIPAL INVESTIGATOR
Arkansas Children's Research Institute
Frequently Asked Questions
Who can join the NCT07422337 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 23 Years, studying B-Cell ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07422337 currently recruiting?
Yes, NCT07422337 is actively recruiting participants. Contact the research team at leappell@uams.edu for enrollment information.
Where is the NCT07422337 trial being conducted?
This trial is being conducted at Little Rock, United States, Springdale, United States.
Who is sponsoring the NCT07422337 clinical trial?
NCT07422337 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is Lauren Appell, MD at Arkansas Children's Research Institute. The trial plans to enroll 300 participants.