CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
St. Jude Children's Research Hospital
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.
Description
Advances in cancer immunotherapies, including CD19-redirected chimeric antigen receptor (CAR) T-cells, are changing the long-term outcome for B-ALL cancer patients. The late effects of these treatments have not been investigated and the impact of this therapy on survivors' long-term outcomes and overall well-being is unknown. The purpose of this study is to determine the feasibility of studying late effects following CAR T-cell therapy through a prospective, observational study for children, adolescent, and young adult (AYA) survivors who are ≥2-years post CD19-CAR T-cell infusion. The study…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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
Location
- St. Jude Children's Research HospitalMemphis, Tennessee