Long-Term Follow-Up Study on Quality of Life and Health After CD19-CAR T-Cell Therapy in Children, Adolescents, and Young Adults with B-Cell Acute Lymphoblastic Leukemia B-ALL

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.

CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions