Clinical trial NCT05362331: Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy
Official title: Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphoma
Leukemia
Plasma Cell Dyscrasia
Keywords: Web Application
CAR-T Therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of participants who access all four CC web application modules at least once
timeFrame: Up to 6 months
measure: Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application.
timeFrame: 1 day
Secondary outcomes:
measure: Number of times that temperature >= 38. degrees Celsius (°C) is reported
timeFrame: Up to 26 days
measure: Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported
timeFrame: Up to 26 days
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Rahul Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References: