NCT07048535 CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
| NCT ID | NCT07048535 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-10-24 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Aimee Talleur, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07048535 clinical trial?
This trial is open to participants of all sexes, studying B-Cell Acute Lymphoblastic Leukemia (B-ALL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07048535 currently recruiting?
Yes, NCT07048535 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07048535 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07048535 clinical trial?
NCT07048535 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Aimee Talleur, MD at St. Jude Children's Research Hospital. The trial plans to enroll 80 participants.
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