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Recruiting 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

Trial Parameters

Condition B-Cell ALL
Sponsor Arkansas Children's Hospital Research Institute
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 1 Year
Max Age 23 Years
Start Date 2026-01-13
Completion 2028-01

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

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