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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
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.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Number of Participants That Received YESCARTA
The number of participants that received YESCARTA as outpatient therapy
Time frame: Approximately 6 weeks
Participants That Required Hospitalization at 72 Hours Post Infusion
Number of subjects that were admitted to hospital at 72 hours post infusion
Time frame: at 72 hours
Participants That Required Hospitalization at 7 Days Post Infusion
Number of subjects that were admitted to the hospital at 7 days post infusion
Time frame: at 7 days
Participants That Required Hospitalization at 14 Days Post Infusion
Number of subjects that were admitted to the hospital at 14 days post infusion
Time frame: at 14 days
Participants That Required Hospitalization at 30 Days Post Infusion
Number of subjects that were admitted to hospital at 30 days post infusion
Time frame: at 30 days
Count of Risk Factors That Preclude Out-patient Administration of YESCARTA
Reasons as to why a participant did not receive YESCARTA in the out-patient setting
Time frame: Approximately 30 days
Participants That Experienced Cytokine Release Syndrome Events
Count of participants that had cytokine release syndrome events
Time frame: Approximately 30 days
Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events
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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
Count of participants that had an immune effector cell-associated neurotoxicity syndrome event
Time frame: Approximately 30 days
Incidence of Steroid Administration During YESCARTA
Count of participants that were administered steroids during treatment
Time frame: Approximately 30 days
Cost Per Patient of Administering YESCARTA in the Out-patient Setting
Cost includes hospital clinic charges and CAR-T acquisition. It was pre-specified to report a single dollar amount that every participant was changed. The amount entered was the amount that each patient was charged. It was not planned to assess this amount separately for each participant.
Time frame: Approximately 30 days