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JOURNAL ONKOLOGIE – STUDIE
CARTePRO

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

Rekrutierend

NCT-Nummer:
NCT05354973

Studienbeginn:
März 2022

Letztes Update:
19.04.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Stiftung Swiss Tumor Institute

Collaborator:
Klinik Hirslanden, Zurich, Palleos Healthcare GmbH,

Studienleiter

Panagiotis Samaras, PD.Dr.med
Principal Investigator
Klinik für Hämatologie und Onkologie

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Response time (Time Frame - 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:

1. Occurrence of CRS-related adverse events (ePRO) (Time Frame - 84 day +/- 6 days):
Occurrence of CRS-related adverse events (ePRO): fever, myalgia, rigors, fatigue, and loss of appetite

2. Number and severity of adverse events (AE) according to the CTCAE (Time Frame - 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").

3. Occurrence and type of therapy-associated unplanned consultations (Time Frame - 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.

4. Adherence (Time Frame - 84 day +/- 6 days):
Adherence, measured as percentage of days during intervention with electronically captured consilium careTM app usage

5. Well-being (Time Frame - 84 day +/- 6 days):
Well-being according to the ECOG Performance Status as daily ePRO before and after CAR T cell reinfusion.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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