NCT05362331

Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy

Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The complex logistics and unique toxicities of chimeric antigen receptor T-cell (CAR-T) therapy require intensive patient education and careful monitoring. The Companion for CAR-T (CC) web app may be able to assist with patient education and preparation, communication between patients and their multidisciplinary teams, and home-based toxicity monitoring.

Detailed description

This is a single-arm pilot study assessing the feasibility and acceptability of the Companion for CAR-T (CC) web app among patients receiving commercially available CAR-T therapies. Primary Objectives: I. To evaluate the feasibility of the CC web app. II. To evaluate the acceptability of the CC web app to patients. Secondary Objectives: I. To quantify the incidence of fevers being reported via the CC web app. II. To quantify the incidence of electronic Immune Effector Cell-Associated Encephalopathy (eICE) deficits being recorded via the CC web app. Exploratory Objectives: I. To explore patient perceptions regarding the CC web app. II. To explore usage patterns regarding the CC web app. III. To explore trends in patient-reported quality of life (QOL), values, and stressors over time during CAR-T therapy. IV. To explore responses to abnormal findings reported or recorded using the CC web app Participants will be given access to the web application from beginning at the day of study enrollment through Day +100 following CAR-T therapy.

Conditions

• Lymphoma
• Leukemia
• Plasma Cell Dyscrasia

Interventions

Type	Name	Description
OTHER	Web Application	Internet based application

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-05-05
• Last updated: 2023-02-09