CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
Purpose
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.
Condition
- B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Memphis, Tennessee 38105
More Details
- Status
- Recruiting
- Sponsor
- St. Jude Children's Research Hospital
Detailed 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 will be the first study of late effects following CAR T-cell therapy recruiting B-ALL survivors from across the United States. Eligible study participants will participate in a comprehensive health assessment. These assessments will include history and physical examination, laboratory studies, a brain MRI, physical performance testing, and neurocognitive testing. The CONQUER study will focus specific attention on data relevant to CD19-CAR T-cell therapy, including immune function.