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

NCT07048535 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Sponsors & Collaborators

Principal Investigators

  • Aimee Talleur, MD · St. Jude Children's Research Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2028-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07048535 on ClinicalTrials.gov