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

Not yet recruiting

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

• Registration Number: NCT07048535
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed Description

Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients.

The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown.

The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States.

Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.

Study Timeline

• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• Primary Completion: 2028-07
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy	Through study completion, approximately 5 years	Estimation of participation rate

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States