About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years
WHO grade 2 astrocytoma or oligodendroglioma
Presence of IDH1- or IDH2-mutation
Surgical intervention
Disqualifiers
Participation in an interventional clinical trial
Patient unable to consent
Other contraindications according to current SmPC.
Trial design
Treatments tested in this trial
- Vorasidenib