Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma (VIOLETA)

iOMEDICO

Status: Enrolling

Conditions: Glioma

Treatments: Drug: Vorasidenib

Study type: Observational

Funder types: Industry

Identifiers

NCT07240662

IOM-120529

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.