RecruitingNCT07422337

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

Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination


Sponsor

Arkansas Children's Hospital Research Institute

Enrollment

300 participants

Start Date

Jan 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 YearMax Age: 23 Years

Inclusion Criteria4

  • 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 Criteria3

  • Relapsed/refractory disease at any time
  • Received or will require a bone marrow transplant and/or cellular therapy
  • Pregnancy

Locations(2)

Arkansas Children's

Little Rock, Arkansas, United States

Arkansas Children's Northwest

Springdale, Arkansas, United States

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NCT07422337


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