CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- 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
Outcomes
Primary Outcomes
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Time Frame: Through study completion, approximately 5 years
Estimation of participation rate
Secondary Outcomes
No secondary outcomes reported