At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
In Brief
A Phase 4 clinical trial evaluating Telemedicine Visit, Vital sign measurements, and 5 other interventions for Large B-cell Lymphoma and Diffuse Large B-cell Lymphoma. Completed, enrolled 25 participants across 1 site.
Detailed Summary
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria
Study Details
Timeline
Interventions
A remote telemedicine visit with audio and video, using the internet with a nurse practitioner (NP) located elsewhere. The participant and NP will activate the telemedicine App in their electronic device. Family will obtain vital signs (BP, heart rate (HR), respiration rate (RR), SPO2) and provide NP with the information. NP will also review the previous vital signs. Review of system questions are asked, and the answers given by subject recorded. Neurological assessment done, and ICE score calculated.
Participant and their family will record and measure vital signs using a wearable device and will place a call to the covering nurse practitioner to report the vital signs prior to reporting to the out patient visit.
Physical exam and review of all available data
Participant and their family take their blood pressure and pulse oximeter
Axicabtagene Ciloleuce given by IV
Given IV
Given IV