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CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * ≤ 26-years old at the time of the first CAR treatment * 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: * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
About the study
To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19)
-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.
Sponsor: St. Jude Children's Research Hospital · Participants: 80 · Started: Oct 24, 2025
Contact the study team
- Aimee Talleur, MD · Phone: 888-226-4343
Official record on ClinicalTrials.gov — NCT07048535
Locations in the U.S.
| Tennessee | St. Jude Children's Research Hospital, Memphis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.