Vorasidenib treatment for adults with 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
This study will try vorasidenib in adults with IDH1- or IDH2-mutant WHO grade 2 diffuse glioma after surgery to see if it affects quality of life and clinical outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT07240662 on ClinicalTrials.gov |
What this trial studies
VIOLETA is a prospective, observational real-world study collecting data on adults treated with vorasidenib for IDH‑mutant WHO grade 2 diffuse glioma in routine German clinical practice. Eligible patients have undergone surgery, do not need immediate radiotherapy or chemotherapy, and are started on vorasidenib according to the current SmPC; enrollment is allowed up to six weeks after the first dose provided treatment is ongoing. The study focuses on patient-reported outcomes in German, with primary emphasis on quality of life and secondary endpoints including seizure burden, progression-free survival, objective response rate, time to next intervention, and safety. Data will be collected from the treating center (NCT Heidelberg) following local practice patterns to describe how vorasidenib is used and tolerated outside of interventional trials.
Who should consider this trial
Good fit: Adults (≥18) with WHO grade 2 astrocytoma or oligodendroglioma carrying an IDH1 or IDH2 mutation who have had surgery, do not require immediate radiotherapy or chemotherapy, and are starting vorasidenib per the product label are the ideal candidates.
Not a fit: Patients who need immediate radiotherapy or chemotherapy, who are enrolled in interventional trials, who cannot provide informed consent, or who have contraindications per the vorasidenib label are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, vorasidenib could help maintain quality of life and delay disease progression in adults with IDH‑mutant WHO grade 2 glioma.
How similar studies have performed: Early-phase clinical studies of vorasidenib have shown promising activity in IDH‑mutant gliomas, but larger and real-world data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Heidelberg
- Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: iOMEDICO
- Email: information@iomedico.com
- Phone: +49761152420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.