CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedStudy Start
First participant enrolled
October 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
April 29, 2026
April 1, 2026
2.7 years
June 24, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Estimation of participation rate
Through study completion, approximately 5 years
Eligibility Criteria
All participants who meet eligibility criteria and consent to enrollment on the study.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
Blood and urine: The collected blood and urine samples will be stored according to the clinical and research infrastructure of the institutional tissue bank - SJLIFE. The samples will be tagged accordingly and will be only released to fulfill future objectives of the CONQUER protocol.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Talleur, MD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 2, 2025
Study Start
October 24, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04