Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
ConditionGlioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsoriOMEDICO AG
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
WHO grade 2 astrocytoma or oligodendroglioma
Presence of IDH1- or IDH2-mutation
Surgical intervention
Disqualifiers
Participation in an interventional clinical trial
Patient unable to consent
Other contraindications according to current SmPC.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vorasidenib
Drugoral, first-in-class, dual inhibitor of mIDH 1 and 2
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
baseline, up to 72 monthsSecondary outcomes
1
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
Evaluate QoL by using the FACT-Br questionnaire at start and during course of vorasidenib treatment. Change from baseline over time for all other scales of the FACT-Br. For all scales, the higher the score the better quality of life.
Time frame
baseline, up to 72 months2
Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity
Proportion of patients with baseline seizure activity is defined as at least 1 seizure in the previous 30 days prior to vorasidenib treatment start
Time frame
baseline, up to 72 months3
Assess seizure activity and severity at baseline and during treatment: event rate of seizures
Exposure adjusted event rate of seizures according to patient-reported outcome (patient diary)
Time frame
baseline, up to 72 months4
Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness
Exposure adjusted event rate of seizures with loss of consciousness according to PRO (patient diary)
Time frame
baseline, up to 72 monthsSponsors and contacts
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Source ClinicalTrials.gov