Actively Recruiting

All Genders
NCT07048535

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

Led by St. Jude Children's Research Hospital · Updated on 2026-04-29

80

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 26 years old or younger at the time of the first CAR treatment
  • Received a CD19-containing CAR T-cell product for B-ALL
  • Received one unique CAR product (reinfusion of the same product is allowed)
  • In sustained remission without additional therapy after CAR treatment (except post-CAR transplant)
  • Received only one prior hematopoietic cell transplant before or after CAR therapy
  • At least 2 years have passed since the last CAR T-cell infusion
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide written informed consent by the participant or legal guardian

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

A

Aimee Talleur, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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