Revaccination of children after completion of standard chemotherapy for acute lymphoblastic leukaemia: a pilot study comparing different schedules.
Thomas Lehrnbecher, Ralf Schubert, Regina Allwinn...
https://pubmed.ncbi.nlm.nih.gov/21250973/Actively Recruiting
Led by Arkansas Children's Hospital Research Institute · Updated on 2026-02-25
300
Participants Needed
2
Research Sites
52 weeks
Total Duration
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
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
L
Lauren Appell, MD
S
Stephanie Thomas, RN
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Arkansas Children's Hospital Research Institute
Lead Sponsor
Columbia University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months after completion of blinatumomab therapy
Participants undergo blood tests to measure protective antibody levels following blinatumomab therapy or no blinatumomab exposure.
1 to 2 visits depending on cohort assignment
Duration - Up to 6 months following revaccination
Participants are observed to assess persistence of protective immunity and response to revaccination if applicable.
Follow-up visits as needed for antibody titer assessments
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor
Columbia University
Collaborating Sponsor