Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany
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.
• Age ≥18 years
• WHO grade 2 astrocytoma or oligodendroglioma
• Presence of IDH1- or IDH2-mutation
• Surgical intervention
• No immediate need of radiotherapy or chemotherapy according to the treating physician
• Decision for treatment with vorasidenib as per current SmPC
• Signed written informed consent\*
• Willingness to participate in Patient-Reported Outcome (PRO) assessment in German language
• Other criteria according to current SmPC \* Patients are allowed to be enrolled up to 6 weeks after their first intake of vorasidenib but must still be on treatment at the time of enrollment