Observational Study on Immunity After Blinatumomab for B-ALL

This study is looking at how well children and young adults (ages 1 to 23) with B-cell Acute Lymphoblastic Leukemia/Lymphoma (B-ALL/Ly) keep their protection from routine childhood vaccinations after being treated with blinatumomab. Blinatumomab is an immunotherapy that targets CD19 on cancer cells. Researchers want to see if your body still has enough protective antibodies from your childhood vaccines at least six months after finishing blinatumomab. They also want to know if getting revaccinated helps restore this protection if your antibody levels are low. The study will compare results from those who received immunotherapy to those who didn't, to understand if immunotherapy affects vaccine protection differently than other chemotherapy drugs. This is an observational study, meaning you won't receive new treatments as part of the study, but your health information will be collected. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure protective antibody levels at least six months after you complete blinatumomab therapy.

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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

Recruiting
Not specifiedAges 1–23Observational
Arkansas Children's Hospital Research Institute
~300 participants
Updated 2026-02-25 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with protective serum antibody titers
Measured over >/= 6 months following the completion of blinatumomab therapy
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
2 sites across 1 states
Arkansas2
  • Lauren Appell, MD · PRINCIPAL_INVESTIGATOR · Arkansas Children's Research Institute

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Eligibility criteria

Inclusion

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

Relapsed/refractory disease at any time
Received or will require a bone marrow transplant and/or cellular therapy
Pregnancy
  • Proportion of participants with protective serum antibody titers>/= 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