Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse 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

Inclusion Criteria:

* 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

Exclusion Criteria:

* Participation in an interventional clinical trial
* Patient unable to consent
* Other contraindications according to current SmPC.

Conditions2

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