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
Recruiting now
Conditions studied: B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia, B-Cell Lymphoblastic Leukemia, B-Cell Lymphoblastic Leukemia/Lymphoma, B-cell Acute Lymphoblastic Leukemia (B-ALL), B-cell Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Leukemia
In brief
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.
Key facts
- Study ID
- NCT07422337
- Run by
- Arkansas Children's Hospital Research Institute
- People needed
- 300
- Starts
- 2026-01-13
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2026-02-25
Who can join
Age: 1 and older, up to 23. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Relapsed/refractory disease at any time
- Received or will require a bone marrow transplant and/or cellular therapy
- Pregnancy
Where it is running
- Arkansas Children's — Little Rock, Arkansas, United States (enrolling)
- Arkansas Children's Northwest — Springdale, Arkansas, United States (enrolling)
Full record on ClinicalTrials.gov
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