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Trial Title:
Vaccine Immune Recovery After Leukemia
NCT ID:
NCT05622682
Condition:
Acute Lymphoblastic Leukemia, Pediatric
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
acute lymphoblastic leukemia
chemotherapy
antineoplastic agents
varicella vaccine
chickenpox vaccine
pneumococcal vaccines
measles vaccine
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational only: Serology and flow cytometry for ALL cohort participants
Description:
Blood samples from ALL cohort participants will be tested to measure antibodies to
vaccine-preventable diseases and immune recovery
Arm group label:
Children, adolescents, and young adults who recently completed ALL treatment
Intervention type:
Other
Intervention name:
Observational only: Infection rates
Description:
Number of infections during the study period will be obtained from both ALL cohort and
healthy control participants and captured for comparison and evaluation of infection
rates during the first year off-chemotherapy.
Arm group label:
Children, adolescents, and young adults who recently completed ALL treatment
Arm group label:
Healthy age- and sex-matched controls
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
3 Years
Maximum age:
31 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ann & Robert H. Lurie Children's Hospital of Chicago
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Helen DeVos Children's Hospital
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Monroe Carell Jr. Children's Hospital at Vanderbilt
Address:
City:
Nashville
Zip:
37232
Country:
United States
Facility:
Name:
CHRISTUS Children's (Affiliate of Baylor College of Medicine)
Address:
City:
San Antonio
Zip:
78207
Country:
United States
Facility:
Name:
Seattle Children's Hospital
Address:
City:
Seattle
Zip:
98105
Country:
United States
Start date:
September 28, 2022
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Children's Hospital of Philadelphia
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Children's Hospital of Philadelphia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05622682
