Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
Recruiting
Observational Study
Glioma
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 150 (estimated)
- Sponsor
- iOMEDICO AG · Industry
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About This Trial
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…
Trial Locations
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Eligibility 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
* Sig…
Contacts