Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
Recruiting now
Conditions studied: Glioma
In brief
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.
Key facts
- Study ID
- NCT07240662
- Run by
- iOMEDICO AG
- People needed
- 150
- Starts
- 2025-12-08
- Expected to finish
- 2032-01-01
- Last updated by the study team
- 2026-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Participation in an interventional clinical trial
- Patient unable to consent
- Other contraindications according to current SmPC.
Where it is running
- Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg, Germany (enrolling)
Full record on ClinicalTrials.gov
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