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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

NCT07422337 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-25

No results posted yet for this study

Summary

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.

Conditions

  • 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

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Lauren Appell, MD · Arkansas Children's Research Institute

Eligibility

Min Age
1 Year
Max Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2028-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07422337 on ClinicalTrials.gov