Actively Recruiting
Study of Blinatumomabs Impact on Vaccine Immunity and Revaccination in Children and Young Adults with B-Cell Acute Lymphoblastic Leukemia or Lymphoma
Led by Arkansas Children's Hospital Research Institute · Updated on 2026-02-25
300
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Arkansas Children's Hospital Research Institute
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how well routine childhood vaccinations protect pediatric patients under 21 years old who have been treated for B-cell Acute Lymphoblastic Leukemia or Lymphoma B-ALLLy, especially those who have received the immunotherapy drug blinatumomab. The study compares patients treated with blinatumomab to those who have not, to see if immunotherapy affects the lasting protection from vaccines. It also seeks to establish clear vaccination guidelines for these patients, since chemotherapy and immunotherapy may weaken their immune defenses. Participants are observed in two groups those who have received blinatumomab and those who have not. The study evaluates whether patients maintain protective antibody levels at least six months after completing blinatumomab therapy. For patients with low immunity, the study will assess if revaccination restores protective antibody levels within six months. The study does not involve new treatments but monitors immune responses over time to routine vaccinations. During the study, participants will have blood tests to measure their antibody levels against common vaccine-preventable diseases. Researchers will track who maintains immunity and who responds to revaccination. The primary measurement is the proportion of patients with protective antibody levels six months post-treatment. The study will continue to monitor participants immune status and response to boosters, helping to inform future vaccination protocols. Participation may last through follow-up visits over several months after therapy completion.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of B-lineage acute lymphoblastic leukemia or lymphoma
- Age 1 year and up to 21 years at diagnosis
- Informed consent provided, and if applicable, child assent provided
- Must have received all vaccinations routinely administered during first year of life
You will not qualify if you...
- Relapsed or refractory disease at any time
- Received or will require a bone marrow transplant and/or cellular therapy
- Pregnancy
Research Team
L
Lauren Appell, MD
S
Stephanie Thomas, RN
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