NCT07240662

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: iOMEDICO AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	Vorasidenib	oral, first-in-class, dual inhibitor of mIDH 1 and 2

Timeline

• Start date: 2025-12-08
• Primary completion: 2031-11-01
• Completion: 2032-01-01
• First posted: 2025-11-21
• Last updated: 2026-01-09

Locations

1 site across 1 country: Germany