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

Patient Reported Outcome Measures Clinical Trial

— CARTePRO  

Official title:

ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study (CARTePRO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354973
• Other study ID #: KEK ZH: 2021-D0077
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Stiftung Swiss Tumor Institute
• Contact: Andreas Trojan, Prof.Dr.med
• Phone: +41 76 343 02 00
• Email: trojan[@]1st.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Reported Outcome Measures

Intervention

Device:
• Consilium CareTM
This is an observational study using the Consilium CareTM smartphone ePRO application.

Locations

Country	Name	City	State
Switzerland	Klinik für Hämatologie und Onkologie	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
Stiftung Swiss Tumor Institute	Klinik Hirslanden, Zurich, Palleos Healthcare GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response time	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.	84 day +/- 6 days
Secondary	Occurrence of CRS-related adverse events (ePRO)	Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite	84 day +/- 6 days
Secondary	Number and severity of adverse events (AE) according to the CTCAE	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").	84 day +/- 6 days
Secondary	Occurrence and type of therapy-associated unplanned consultations	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.	84 day +/- 6 days
Secondary	Adherence	Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage	84 day +/- 6 days
Secondary	Well-being	Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.	84 day +/- 6 days