NCT05108805

Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

Primary Objectives * To explore the feasibility of treating subjects with YESCARTA in the outpatient setting and guide the development of a subsequent, larger study that will determine the tolerability and safety profile of YESCARTA in the outpatient setting. * To determine the time to specific interventions post infusion and the number of subjects who remain outpatient through 72 hours, 7, 14, and 30 days. Secondary Objectives: * Identify risk factors that preclude outpatient administration, and to obtain clinical data that will guide the development of guidelines by which YESCARTA treatment in the outpatient setting can be done safely. * Assess the impact of close monitoring with telemedicine and twice-daily physical exam on specific outcomes including CRS and ICANS in subjects treated with YESCARTA in the outpatient setting. * Cumulative steroid exposure within 28 days post YESCARTA infusion. * To calculate the estimated cost of YESCARTA administered in the outpatient setting. Exploratory Objectives: * Time from YESCARTA infusion to the following: fever, fever with neutropenia, fever without neutropenia. * Time from fever to Tocilizumab, fever to ICU admission, fever to low BP, fever to IV Fluid, fever to vasopressor, fever to onset to arrhythmias and fever to hospitalization. * Calculate modified Neutropenic Fever Symptom Burden (NFSB) score for days 1-3 for each subject. Appendix D * Obtain subject reported outcomes measured by Subject-Reported Outcomes Measurement Information System (PROMIS; Appendix F) \[16, 17\] * Feasibility of using wearable devices to monitor vital signs in the outpatient setting. Data collected are for research only

Conditions

• Large B-cell Lymphoma
• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Telemedicine Visit	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.
PROCEDURE	Vital sign measurements	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.
PROCEDURE	Out-Patient Clinic Visit	Physical exam and review of all available data
PROCEDURE	Blood pressure and pulse oximeter	Participant and their family take their blood pressure and pulse oximeter
BIOLOGICAL	Axicabtagene Ciloleucel	Axicabtagene Ciloleuce given by IV
DRUG	Cyclophosphamide	Given IV
DRUG	Fludarabine	Given IV

Timeline

• Start date: 2021-12-02
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2021-11-05
• Last updated: 2025-03-27
• Results posted: 2025-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study