Vaccine Immune Recovery After Leukemia
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Interventions
- Other: Observational only
- Registration Number
- NCT05622682
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
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 90 pediatric participants and up to 270 healthy control patients. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 360
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Children, adolescents, and young adults who recently completed ALL treatment Observational only This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery.
- Primary Outcome Measures
Name Time Method Incident infection rate in subjects one year post acute lymphoblastic leukemia therapy compared to the incident infection rate in healthy controls 1 year Infections will include clinical and/or microbiologically confirmed infections. 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 1000 follow-up days. All infection rates will be reported as a post estimate with 95 percent confidence intervals. Patients will be censored at time of loss to follow-up or death.
- Secondary Outcome Measures
Name Time Method Proportion of patients with seroprevalence of pneumococcus antibodies at each study timepoint 1 year 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.
B lymphocyte recovery in a subset of patients 1 year B lymphocyte subsets will be measured for a subset of the 75 enrolled subjects. These measurements will be reported for each subject at approximately 3, 6, and 12 months. The trajectory of these measurements will be displayed graphically across the three timepoints of interest to assess relative recovery of lymphocyte quantities after completion of ALL chemotherapy.
T lymphocyte recovery in a subset of patients 1 year T lymphocyte subsets will be measured for a subset of the 75 enrolled subjects. These measurements will be reported for each subject at approximately 3, 6, and 12 months. The trajectory of these measurements will be displayed graphically across the three timepoints of interest to assess relative recovery of lymphocyte quantities after completion of ALL chemotherapy.
Proportion of patients with seroprevalence of measles antibodies at each study timepoint 1 year 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.
Proportion of patients with seroprevalence of varicella antibodies at each study timepoint 1 year 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.
Trial Locations
- Locations (6)
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
CHRISTUS Children's (Affiliate of Baylor College of Medicine)
🇺🇸San Antonio, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States