Vaccine Immune Recovery After Leukemia

Children's Hospital of Philadelphia89 enrolled

Overview

This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 100 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

Observational only: Serology and flow cytometry for ALL cohort participantsOTHER

Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery

Observational only: Infection ratesOTHER

Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 31 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older * Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months * Three years of age or older at time of enrollment Exclusion Criteria: * Diagnosis of infant ALL * Evidence of disease relapse * History of primary immunodeficiency (except related to Down Syndrome) * History of a stem cell transplant or cellular immunotherapy * History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis

Locations (6)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy

Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death.

Time frame: 1 year

Secondary Outcomes

Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint

The seroprevalence proportions for measles antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

Time frame: 1 year

Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint

The seroprevalence proportions for varicella antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

Time frame: 1 year

Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint

The seroprevalence proportions for pneumococcal antibodies (23 serotypes) will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

Data from ClinicalTrials.gov

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