Long-term health follow-up of young people treated with CAR T-cell therapy for leukemia
Studies long-term health of young patients with B-cell acute lymphoblastic leukemia after CAR T-cell therapy.
Key facts
- Who runs it
- St. Jude Children's Research Hospital
- Where
- Memphis, United StatesSee the site
- Trial code
- Registry title
- CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 24 Oct 2025
- Expected to end
- Jul 2029
- Type of study
- Observational
- Record updated
- 29 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people treated for B-cell acute lymphoblastic leukemia (B-ALL) with CD19 CAR T-cells, at least 2 years after the last infusion. It follows their long-term health.
- Age
- 26 years old or younger at the time of the first CAR treatment.
- Sex
- All sexes can join.
- Disease stage
- B-cell acute lymphoblastic leukemia (B-ALL) in sustained remission without further therapy after the CAR T-cells (except a consolidative transplant, HCT, after CAR).
- Earlier treatment
- Must have received one CD19-containing CAR T-cell product (investigational or commercial); reinfusion of the same product is allowed. At least 2 years since the last CAR T-cell infusion. Only one prior HCT (before or after CAR).
Main reasons for not taking part
- Cannot or does not want to give written informed consent (participant or legal guardian/representative)
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- ≤ 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
Who cannot take part
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Where in United States
- St. Jude Children's Research HospitalMemphis, United StatesContact: Aimee Talleur, MDTaking people
About the trial
What the trial wants to find out
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)
Read full original descriptionShow less
-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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
- Plain-language title
- Long-term health follow-up of young people treated with CAR T-cell therapy for leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 April 2026