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

Recruiting now

Conditions studied: B-Cell Acute Lymphoblastic Leukemia (B-ALL)

In brief

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.

Key facts

Study ID

NCT07048535

Run by

St. Jude Children's Research Hospital

People needed

80

Starts

2025-10-24

Expected to finish

2029-07-01

Last updated by the study team

2026-04-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≤ 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

You may not qualify if…

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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