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Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

NCT07240662 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vorasidenib

oral, first-in-class, dual inhibitor of mIDH 1 and 2

Sponsors & Collaborators

  • iOMEDICO AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2031-11-30
Completion
2032-01-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07240662 on ClinicalTrials.gov