Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

ConditionGlioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG

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

Treatment groups

No treatment groups listed

Sponsors and collaborators