Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

NCT07240662 | Recruiting

• 1 other identifier: IOM-120529
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Glioma

Keywords

WHO Grade 2; IDH-mutant; diffuse

Outcome Measures

Primary Outcomes (1)

• Evaluate Quality of Life (QoL) by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire over the course of treatment

  Evaluate QoL by the FACT-Br questionnaire over the course of treatment. Change from baseline in the FACT-Br total score over time. The FACT-Br total score ranges from 0 to 200, with higher scores indicating better quality of life.

  baseline, up to 72 months

Secondary Outcomes (30)

• Evaluate Quality of Life (QoL) by using the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire at start and during course of vorasidenib treatment

  baseline, up to 72 months

• Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity

  baseline, up to 72 months

• Assess seizure activity and severity at baseline and during treatment: event rate of seizures

  baseline, up to 72 months

• Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness

  baseline, up to 72 months

• Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures

  baseline, up to 72 months

Interventions

Vorasidenib DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (at least 40 kg) with predominantly non-enhancing grade 2 astrocytoma or oligodendroglioma with an IDH1 or IDH2 mutation who only had surgical intervention and are not in immediate need of radiotherapy or chemotherapy.

You may qualify if:

• 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

You may not qualify if:

• Participation in an interventional clinical trial
• Patient unable to consent
• Other contraindications according to current SmPC.

Sponsors & Collaborators

• iOMEDICO AG: lead

Study Sites (1)

Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

Heidelberg, Germany

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

vorasidenib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

iOMEDICO

CONTACT

+49761152420; information@iomedico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 21, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): January 1, 2032
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

DE (1)