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

Study Overview
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Brief Summary
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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.

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

Conditions
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CAR T-Cell Therapy, Patient Reported Outcome Measures

Intervention / Treatment
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* Device: Consilium CareTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed ICF Patients > 18 years Patients receiving CAR T cell treatment Personal smartphone with iOS or Android system. The operating system must be updated to one of the two newest main versions. Exclusion Criteria: 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. Patients with insufficient knowledge about the use of a smartphone.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAR T Cell Treatment<br> | Device: Consilium CareTM<br>* This is an observational study using the Consilium CareTM smartphone ePRO application.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR T-Cell Therapy, ePRO, PRO, Patient Reported Outcome Measure, Immunotherapy