NCT07422337 · Arkansas Children's Hospital Research Institute
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
(BOOSTER)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Proportion of participants with protective serum antibody titers
Time frame: >/= 6 months following the completion of blinatumomab therapy
Participants will have antibody titers evaluated as standard of care. Titers evaluated include: tetanus, Haemophilus influenzae type b \[Hib\], Hepatitis B, Streptococcus pneumoniae \[pneumococcal\], Varicella Zoster Virus, and Measles
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Little Rock, Arkansas
- Springdale, Arkansas
Collaborators
Columbia University
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations