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

NCT05108805 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-27

Study results available
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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

Conditions

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

Sponsors & Collaborators

  • Kite, A Gilead Company

    collaborator INDUSTRY

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Olalekan Oluwole, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-02
Primary Completion
2023-12-08
Completion
2023-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108805 on ClinicalTrials.gov