CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
NCT ID: NCT07048535
Last Updated: 2025-11-12
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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RECRUITING
80 participants
OBSERVATIONAL
2025-10-24
2029-07-31
Brief Summary
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-redirected chimeric antigen receptor (CAR) T-cells.
Primary Objective:
To evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure.
Exploratory Objectives:
* To describe the prevalence of persistent and new/late-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL.
* To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy.
* To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy.
* To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.
Detailed Description
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The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.
The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.
Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL
* Receipt of one unique CAR product (reinfusion of same product allowed)
* Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)
* Receipt of only one prior HCT (inclusive of pre- or post-CAR)
* ≥ 2-years post last CAR T-cell infusion
Exclusion Criteria
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Aimee Talleur, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Aimee Talleur, MD
Role: primary
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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CONQUER
Identifier Type: -
Identifier Source: org_study_id