Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Rahul Banerjee, MD
Headshot of Rahul Banerjee
Rahul Banerjee

Description

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.

Official Title

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

Details

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.

Keywords

Lymphoma Leukemia Plasma Cell Dyscrasia Web Application CAR-T Therapy Multiple Myeloma Neoplasms, Plasma Cell Paraproteinemias Companion for CAR-T Web Application (CC)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of a hematologic malignancy (including any plasma cell dyscrasia, any type of lymphoma, or any type of leukemia).
  • Planned receipt of an FDA-approved CAR-T therapy at University of California, San Francisco (UCSF) as standard of care.
  • Patient proficiency in spoken and written English.
  • Caregiver proficiency in spoken and written English.
  • Age >= 18 years old

You CAN'T join if...

  • FDA-approved CAR-T therapy being administered as part of a prospective industry-sponsored trial, for example registrational trials of CAR-T therapy versus salvage chemotherapy or CAR-T therapy as an off-label line of therapy.

*However, patients who receive an FDA-approved CAR-T therapy through an Expanded Access Program for non-conforming products (or any observational, non-interventional analysis of CAR-T products) are eligible.

  • Lack of ownership of a personal computing device, tablet device, or smartphone.
  • Refusal of patient and/or caregiver to sign up for a UCSF MyChart account.

*Participants and caregivers who do not have a MyChart account at enrollment but are willing to create one will receive assistance from the study team to do so.

  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could - in the opinion of the study's Principal Investigator (PI) - interfere with provision of informed consent or compliance with study procedures.

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Rahul Banerjee, MD
    Clinical Instructor Volunteer, Medicine, School of Medicine. Authored (or co-authored) 45 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05362331
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated