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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05362331
• Other study ID #: 212527
• Secondary ID: NCI-2022-03845
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Dyscrasia

Intervention

Other:
• Web Application
Internet based application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who access all four CC web application modules at least once	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.	Up to 6 months
Primary	Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application.	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.	1 day
Secondary	Number of times that temperature >= 38. degrees Celsius (°C) is reported	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.	Up to 26 days
Secondary	Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported	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.	Up to 26 days