Actively Recruiting
Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
Led by iOMEDICO AG · Updated on 2026-01-09
150
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with WHO grade 2 astrocytoma or oligodendroglioma
- Presence of IDH1- or IDH2-mutation
- Have undergone surgical intervention
- No immediate need for radiotherapy or chemotherapy as determined by the treating physician
- Decision to treat with vorasidenib according to current SmPC
- Signed written informed consent
- Willingness to participate in Patient-Reported Outcome assessments in German
- Other criteria according to current SmPC
- Enrollment allowed up to 6 weeks after first intake of vorasidenib but must still be on treatment at enrollment
You will not qualify if you...
- Participation in an interventional clinical trial
- Unable to provide consent
- Other contraindications according to current SmPC
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany
Actively Recruiting
Research Team
I
iOMEDICO
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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