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

Diffuse Large B-cell Lymphoma Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT05108805
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2021
• Completion date: December 31, 2024