Condition: Glioma · Sponsor: iOMEDICO AG
The goal of this prospective, observational study VIOLETA is to collect real-world data on vorasidenib treatment in a broad patient population. Though vorasidenib can be administered from 12 years old, VIOLETA focuses on adult patients with IDH1- or IDH2-mutant WHO grade 2 glioma who receive vorasidenib following surgery according to the current SmPC. Thus, VIOLETA will evaluate for the first-time treatment with vorasidenib in German clinical routine. To gain knowledge about how vorasidenib treatment affects patients' well-being, the primary objective of the study is to assess patients' quality of life. Further patient-relevant endpoints addressed by this study will include seizure burden, PFS, Objective Response Rate (ORR), TTNI, safety as well as factors affecting treatment decision making.
This description comes directly from the study's public registry record.
iOMEDICO · +49761152420 · information@iomedico.com
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| Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg | Heidelberg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07240662