Status:
WITHDRAWN
Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy
Lead Sponsor:
University of California, San Francisco
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 Objective...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05362331
Start Date
January 1 2023
End Date
June 30 2025
Last Update
February 9 2023
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