Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-08

Study Completion Date

2032-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vorasidenib

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

Intervention Type DRUG

Eligibility Criteria

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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