Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
400 participants
OBSERVATIONAL
2022-09-28
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children, adolescents, and young adults who recently completed ALL treatment
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.
Observational only: Serology and flow cytometry for ALL cohort participants
Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery
Observational only: Infection rates
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.
Healthy age- and sex-matched controls
Healthy control patients matched to ALL cohort patient on age and sex will be selected for comparison of infection rates during the same calendar year as each ALL cohort participant's study period. Healthy controls will be matched to ALL participants 3:1, with up to a total of 300 controls selected.
Observational only: Infection rates
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.
Interventions
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Observational only: Serology and flow cytometry for ALL cohort participants
Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery
Observational only: Infection rates
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* For participants enrolled after 1/1/2025, received blinatumomab as part of up-front chemotherapy protocol
Exclusion Criteria
* 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
3 Years
31 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Brian T Fisher, DO MSCE MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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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
CHRISTUS Children's (Affiliate of Baylor College of Medicine)
San Antonio, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Other Identifiers
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61366
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
21-019426
Identifier Type: -
Identifier Source: org_study_id
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