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| Name | Class |
|---|---|
| Klinik Hirslanden, Zurich | OTHER |
| Palleos Healthcare GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR T Cell Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consilium CareTM | Device | This is an observational study using the Consilium CareTM smartphone ePRO application. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years or older receiving CAR T Cell therapy and congnitive ability to utilitze a smartphone.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Trojan, Prof.Dr.med | Contact | +41 76 343 02 00 | trojan@1st.ch |
| Name | Affiliation | Role |
|---|---|---|
| Panagiotis Samaras, PD.Dr.med | Klinik für Hämatologie und Onkologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Hämatologie und Onkologie | Recruiting | Zurich | 8032 | Switzerland |
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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 |