ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy

Recruiting

• Conditions: CAR T-Cell Therapy; Patient Reported Outcome Measures
• Interventions: Device: Consilium CareTM

• Registration Number: NCT05354973
• Lead Sponsor: Stiftung Swiss Tumor Institute

Brief Summary

This study is designed as a feasibility study implementing electronic Patient Reported Outcomes (ePRO) in CAR T treatment for hematological malignancies, in order to describe AE reporting. ePRO assessments will be explored for their feasibility to engage in monitoring and management of CAR T-related toxicities as well as using these digital ePRO tools may improve both, its safety and accessibility.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-05-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. Signed ICF
2. Patients > 18 years
3. Patients receiving CAR T cell treatment
4. Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions.

Exclusion Criteria

1. Patients, whose compliance to the studies' protocol, e.g. due to mental health problems, physical problems, or the private life situation, can be justifiably doubted.
2. Patients with insufficient knowledge about the use of a smartphone.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAR T Cell Treatment	Consilium CareTM	-

Primary Outcome Measures

Name	Time	Method
Response time	84 day +/- 6 days	Response time in seconds obtained during trail-making test (ePRO) according to daily administration via consilium careTM app, as a potential indicator for ICANS and other CAR T cell therapy-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Occurrence and type of therapy-associated unplanned consultations	84 day +/- 6 days	Occurrence and type of therapy-associated unplanned consultations. Unplanned consultations are defined as additional consultations outside of planned therapy or control visits at the treatment center or with the investigator, as well as unplanned visits to other physicians or emergency services.
Well-being	84 day +/- 6 days	Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.
Occurrence of CRS-related adverse events (ePRO)	84 day +/- 6 days	Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite
Adherence	84 day +/- 6 days	Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage
Number and severity of adverse events (AE) according to the CTCAE	84 day +/- 6 days	Number and severity of adverse events (AE) according to the Common Terminology Criteria for Adverse Events (CTCAE) after 12 weeks (ePRO).; CTCAE on a 5 point scale: Grade 1 is mild, grade 2 moderate, grade 3 severe, grade 4 life-threatening, and grade 5 corresponds to death. Grade 3 and higher correspond to the WHO definition of serious adverse drug reaction ("serious ADR").

Trial Locations

Locations (1)

Klinik für Hämatologie und Onkologie; 🇨🇭 Zürich, Switzerland