RecruitingNCT07240662

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

Sponsor

iOMEDICO AG

Enrollment

150 participants

Start Date

Dec 8, 2025

Study Type

OBSERVATIONAL

Conditions

Glioma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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