CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions

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.

NCT Number	NCT07048535
Lead Sponsor	St. Jude Children's Research Hospital
Conditions	B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Enrollment	80 participants
Start Date	2025-10-24
Primary Completion	2028-07 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-04-29