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NCT07048535 · ClinicalTrials.gov registry record
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
A clinical trial of B-cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT07048535: Recruiting study of B-cell Acute Lymphoblastic Leukemia (B-ALL), sponsored by St. Jude Children's Research Hospital.
NCT07048535 is a study of B-cell Acute Lymphoblastic Leukemia (B-ALL) that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 80 participants, below the 119-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07048535, a study of B-cell Acute Lymphoblastic Leukemia (B-ALL), is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Estimation of participation rate
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-24 |
| Est. Completion | 2029-07 |
What NCT07048535 shows while recruiting
NCT07048535 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 119-participant average among 6 other B-cell Acute Lymphoblastic Leukemia (B-ALL) trials with a reported enrollment target (33% lower).
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia (B-ALL) appearing as the primary indexed condition, and to 0 interventions.
NCT07048535 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT07048535 about?
NCT07048535 is a clinical study titled "CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions". 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 as...
What is the current status of trial NCT07048535?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2025-10-24. Estimated completion is 2029-07.
What conditions does trial NCT07048535 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL).
Who is sponsoring clinical trial NCT07048535?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07048535 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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