Actively Recruiting

Age: 1Year - 23Years
All Genders
ID07422337

Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination

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-ALL/Ly), 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

Age: 1Year - 23Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Trial Site Locations

Total: 2 locations

1

Arkansas Children's

Little Rock, Arkansas, United States, 72202

Actively Recruiting

2

Arkansas Children's Northwest

Springdale, Arkansas, United States, 72762

Actively Recruiting

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Research Team

L

Lauren Appell, MD

S

Stephanie Thomas, RN

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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