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

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 2, 2021

Primary Completion Date

December 8, 2023

Study Completion Date

December 8, 2023

Conditions
Large B-cell LymphomaDiffuse Large B-cell Lymphoma
Interventions
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

Trial Locations (1)

37232

Vanderbilt-Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

Kite, A Gilead Company

INDUSTRY

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT05108805 - Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting | Biotech Hunter | Biotech Hunter