Vaccine Immune Recovery After Leukemia (VIRAL)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Treatments: Other: Observational only: Serology and flow cytometry for ALL cohort participants; Other: Observational only: Infection rates

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05622682

61366 (Other Grant/Funding Number)

21-019426

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 3 to 31 years old

Volunteers: No Healthy Volunteers

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

Trial design

89 participants in 1 patient group

Children, adolescents, and young adults who recently completed ALL treatment

Description:

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.

Treatment:

Other: Observational only: Infection rates

Other: Observational only: Serology and flow cytometry for ALL cohort participants