Actively Recruiting
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions in Pediatric and Young Adult B-Cell Acute Lymphoblastic Leukemia Survivors
Led by St. Jude Children's Research Hospital · Updated on 2026-04-29
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the long-term health outcomes of pediatric, adolescent, and young adult survivors of B-Cell Acute Lymphoblastic Leukemia (B-ALL) who have been treated with CD19-redirected chimeric antigen receptor (CAR) T-cell therapy. The study aims to evaluate the feasibility of standardized clinical assessments across multiple institutions using the St Jude Lifetime Cohort (SJLIFE) infrastructure. It also explores the prevalence of ongoing and new health conditions, neurocognitive and neurologic function, immune health, and functional status at least two years after CAR T-cell therapy. Participants will undergo comprehensive health evaluations including medical history review, physical exams, laboratory tests, brain MRI, physical performance assessments, and neurocognitive testing. This observational study focuses on data related to CD19-CAR T-cell therapy and its effects on immune function. The assessments are designed to gather detailed information on the survivors' health and quality of life long after treatment. During the study, researchers will monitor participants for approximately five years, assessing their health status and any late effects of therapy. Evaluations will include standardized clinical assessments and various tests to measure physical, neurological, and immune function. The study is observational, involving no additional treatments, and aims to improve understanding of long-term outcomes for B-ALL survivors treated with CAR T-cell therapy.
CONDITIONS
Brief Title
CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 26 years old or younger at the time of first CAR treatment
- Received a CD19-containing CAR T-cell product for B-Cell Acute Lymphoblastic Leukemia
- Received only one unique CAR T-cell product (reinfusion of the same product allowed)
- In sustained remission without additional therapy after CAR treatment (except post-CAR consolidative transplant)
- Received only one prior hematopoietic cell transplant (before or after CAR therapy)
- At least 2 years have passed since last CAR T-cell infusion
You will not qualify if you...
- Inability or unwillingness to provide written informed consent by participant or legal guardian
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At enrollment
Participants undergo comprehensive health assessments including history and physical examination, laboratory studies, brain MRI, physical performance testing, and neurocognitive testing to evaluate late effects following CAR T-cell therapy.
1 visit (in-person)
Duration - Up to approximately 5 years
Participants are observed over time to assess long-term health outcomes and overall well-being following CAR T-cell therapy.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
A
Aimee Talleur, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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