Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorasidenib | Drug | Vorasidenib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate Quality of Life (QoL) by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire over the course of treatment
- timeFrame
- baseline, up to 72 months
- description
- Evaluate QoL by the FACT-Br questionnaire over the course of treatment. Change from baseline in the FACT-Br total score over time. The FACT-Br total score ranges from 0 to 200, with higher scores indicating better quality of life.
Secondary outcomes (30)
- measure
- Evaluate Quality of Life (QoL) by using the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire at start and during course of vorasidenib treatment
- timeFrame
- baseline, up to 72 months
- description
- Evaluate QoL by using the FACT-Br questionnaire at start and during course of vorasidenib treatment. Change from baseline over time for all other scales of the FACT-Br. For all scales, the higher the score the better quality of life.
- measure
- Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available