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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07048535
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Oct 24, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
80 participants (estimated)

Primary Outcome Measure

To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy [ Time Frame: Through study completion, approximately 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Aimee Talleur, MD
[email protected]
888-226-4343

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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