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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Reported Outcome Measures; CAR T-Cell Therapy
• Intervention / Treatment: Device: Consilium CareTM

• Study Type: Observational
• Enrollment (Estimated): 11

Contacts and Locations

• Study Contact: Name: Andreas Trojan, Prof.Dr.med; Phone Number: +41 76 343 02 00; Email: trojan@1st.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • Klinik für Hämatologie und Onkologie
    • Contact: Panogiotis Samaras, PD. Dr.med.; Phone Number: +0762323819; Email: panagiotis.samaras@kho.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CAR T Cell Treatment	Device: Consilium CareTM; This is an observational study using the Consilium CareTM smartphone ePRO application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adherence	Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage	84 day +/- 6 days
Well-being	Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.	84 day +/- 6 days

Collaborators and Investigators

• Sponsor: Stiftung Swiss Tumor Institute
• Collaborators: Klinik Hirslanden, Zurich; Palleos Healthcare GmbH
• Investigators: Principal Investigator: Panagiotis Samaras, PD.Dr.med, Klinik für Hämatologie und Onkologie

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; PRO; ePRO; Patient Reported Outcome Measure; CAR T-Cell Therapy
• Other Study ID Numbers: KEK ZH: 2021-D0077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO