CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt. Jude Children's Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≤ 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)
Disqualifiers
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Trial population
All participants who meet eligibility criteria and consent to enrollment on the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To evaluate the feasibility of conducting standardized clinical assessments of pediatric and AYA B-ALL survivors post CD19-CAR T-cell therapy
Estimation of participation rate
Time frame
Through study completion, approximately 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov