Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Sponsor
iOMEDICO AG
Study ID
NCT07240662
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    oral, first-in-class, dual inhibitor of mIDH 1 and 2

Study Details

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 Dates

Start date
Dec 8, 2025
Status verified
Jan 2026
Primary completion
Nov 30, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Evaluate Quality of Life (QoL) by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire over the course of treatment [ Time Frame: baseline, up to 72 months ]

Central Contacts

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