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

• ClinicalTrials.gov Identifier: NCT05362331
• Recruitment Status: Not yet recruiting
• First Posted: May 5, 2022
• Last Update Posted: May 6, 2022
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Lymphoma; Leukemia; Plasma Cell Dyscrasia	Other: Web Application	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy
• Estimated Study Start Date: July 1, 2022
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm

Intervention/treatment

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.

Other: Web Application; Internet based application; Other Names: Companion for CAR-T Web Application; CAR-T Web Application (CC); CAR-T Web App

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants who access all four CC web application modules at least once [ Time Frame: Up to 6 months ]
   The percentage of participants who access all four CC web application modules at least once from the date of study enrollment through Day +100 after CAR-T therapy will be reported. To meet the acceptability criteria, a threshold of 70% of participant engagement or higher must be met.
2. Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application. [ Time Frame: 1 day ]
   Percentage of participants agreeing or strongly agreeing with the statement, "The Companion for CAR-T web app was helpful during my experience with CAR-T therapy." from a one time assessment administered between Day +29 and Day +100 following CAR-T therapy will be reported. This question ranks the helpfulness of the CC application on a scale of 1 (strongly disagree) to 5 (strongly agree). Participants must select an item score of 4 (agree) or 5 (strongly agree). To meet the feasibility criteria, a threshold of 70% of participant agreement or higher must be met.

Secondary Outcome Measures :

1. Number of times that temperature >= 38. degrees Celsius (°C) is reported [ Time Frame: Up to 26 days ]
   The number of times (pooled across all patients) that an internal body temperature >= 38.0°C is reported by the participants via the CC web application between Day +2 to Day +28 following CAR-T therapy.
2. Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported [ Time Frame: Up to 26 days ]
   The number of times (pooled across all patients) that a new eICE deficit is recorded via the CC web application between Day +2 to Day +28 following CAR-T therapy.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Kate Rafanova; (415) 502-4751; kate.rafanova@ucsf.edu

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

Contact: Kate Rafanova 415-502-4751 kate.rafanova@ucsf.edu

Contact 877-827-3222 cancertrials@ucsf.edu

Principal Investigator: Rahul Banerjee, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Rahul Banerjee, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05362331
• Other Study ID Numbers: 212527; NCI-2022-03845 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
• First Posted: May 5, 2022
• Last Update Posted: May 6, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Web Application; CAR-T Therapy

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders