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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

RECRUITINGSponsored by Arkansas Children's Hospital Research Institute
Actively Recruiting
SponsorArkansas Children's Hospital Research Institute
Started2026-01-13
Est. completion2028-01
Eligibility
Age1 Year – 23 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT07422337

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

Age: 1 Year – 23 YearsHealthy volunteers accepted
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

Conditions9

B Cell Acute Lymphoblastic Leukemia (B-ALL)B-Cell ALLB-Cell Acute Lymphoblastic LeukaemiaB-Cell LeukemiaB-Cell Lymphoblastic LeukemiaB-Cell Lymphoblastic Leukemia/LymphomaB-cell Acute Lymphoblastic LeukemiaB-cell Childhood Acute Lymphoblastic LeukemiaCancer

Locations2 sites

Arkansas Children's
Little Rock, Arkansas, 72202
Stephanie Thomas, RN501-364-3820chamnesssl@archildrens.org
Arkansas Children's Northwest
Springdale, Arkansas, 72762
Cristyn Branstetter, MD479-770-5921CBranstetter@uams.edu

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