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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05362331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rahul Banerjee, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lymphoma, Leukemia, Plasma Cell Dyscrasia
Additional 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.

Arms & Interventions

Arms

Experimental: Companion for CAR-T Web Application (CC)

Enrolled participants and caregivers will receive access to the CC web application during the participants Chimeric Antigen Receptor T-cell (CAR-T) therapy. Key components include (1) educational videos and materials, (2) appointment calendars and 'Appointment Companion' features to prepare for clinical appointments, and (3) tools to assist with vital sign and neurological monitoring at home.

Interventions

Other: - Web Application

Internet based application

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Laurel Brechtel

Laurel.Brechtel@ucsf.edu

415-502-1564