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Recruiting NCT07240662

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

— Observational Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vorasidenib.
Who it may be relevant to
Registry conditions: Glioma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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 [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: event rate of seizures [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures with loss of consciousness [Time frame: baseline, up to 72 months]
  • Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures [Time frame: max. 72 months; from patient-specific study start to end of study (during vorasidenib treatment and follow-up)]
  • Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures with loss of consciousness [Time frame: baseline, up to 72 months]
  • Assess effectiveness in routine treatment: Progression-free survival [Time frame: baseline, up to 72 months]
  • Assess effectiveness in routine treatment: Overall Survival (OS) [Time frame: baseline, up to 72 months]
  • Assess effectiveness in routine treatment: Objective response rate (ORR) [Time frame: max. 72 months; from patient-specific study start to end of study (during vorasidenib treatment and follow-up)]
  • Assess effectiveness in routine treatment: Disease Control Rate (DCR) [Time frame: baseline, up to 72 months]

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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg — Heidelberg

Identifiers

NCT: NCT07240662 · IOM-120529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗