Clinical trial NCT05622682: Vaccine Immune Recovery After Leukemia
Official title: A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Keywords: acute lymphoblastic leukemia
chemotherapy
antineoplastic agents
varicella vaccine
chickenpox vaccine
pneumococcal vaccines
measles vaccine
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-11-18
Enrollment: 360
Sex: ALL
Minimum age (years): 3
Maximum age (years): 31
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, adolescents, and young adults receiving care at a participating pediatric oncology/hematology center who recently completed or will soon complete treatment for acute lymphoblastic leukemia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incident infection rate in subjects one year post acute lymphoblastic leukemia therapy compared to the incident infection rate in healthy controls
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients with seroprevalence of measles antibodies at each study timepoint
timeFrame: 1 year
measure: Proportion of patients with seroprevalence of varicella antibodies at each study timepoint
timeFrame: 1 year
measure: Proportion of patients with seroprevalence of pneumococcus antibodies at each study timepoint
timeFrame: 1 year
measure: B lymphocyte recovery in a subset of patients
timeFrame: 1 year
measure: T lymphocyte recovery in a subset of patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: San Antonio
country: United States
facility: CHRISTUS Children's (Affiliate of Baylor College of Medicine)
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Brian T Fisher, DO MSCE MPH
role: PRINCIPAL_INVESTIGATOR
References: