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

Stiftung Swiss Tumor Institute11 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Patient Reported Outcome Measures CAR T-Cell Therapy

Interventions

Consilium CareTMDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Klinik für Hämatologie und Onkologie

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 84 day +/- 6 days

Secondary Outcomes

Occurrence of CRS-related adverse events (ePRO)

Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite

Time frame: 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").

Time frame: 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.

Time frame: 84 day +/- 6 days

Adherence

Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage

Time frame: 84 day +/- 6 days

Well-being

Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.

Central Contacts

Andreas Trojan, Prof.Dr.med

CONTACT

+41 76 343 02 00 trojan@1st.ch

Data from ClinicalTrials.gov

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