GliomaVIOLETANCT07240662
Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma
An observational study of Glioma, run by iOMEDICO AG at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Vorasidenib
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2025to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- Participation in an interventional clinical trial
- Patient unable to consent
- Other contraindications according to current SmPC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg
Wolfgang Wick, Prof. Dr., +496221567075, nct.neuroonko@med.uni-heidelberg.de
About this study
Official title: Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany
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
- Being tested
- Vorasidenib
- Keywords
- WHO Grade 2, IDH-mutant, diffuse
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VorasidenibDrug
oral, first-in-class, dual inhibitor of mIDH 1 and 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: baseline, up to 72 months
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
Measured: baseline, up to 72 months
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)
Measured: baseline, up to 72 months
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)
Measured: baseline, up to 72 months
Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures
Exposure adjusted incidence rate of seizures according to patient-recorded outcome
Measured: baseline, up to 72 months
Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures with loss of consciousness
Exposure adjusted incidence rate of seizures according to patient-reported outcome
Measured: baseline, up to 72 months
Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures
Change from baseline of seizures reported by the patients during course of treatment
Measured: 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
Change from baseline of seizures with loss of consciousness reported by the patients during course of treatment
Measured: baseline, up to 72 months
Assess effectiveness in routine treatment: Progression-free survival
PFS ist defined as time interval measured from the day of first vorasidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.
Measured: baseline, up to 72 months
Assess effectiveness in routine treatment: Overall Survival (OS)
OS is defined as the time interval measured form the day of first vorasidenib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.
Measured: baseline, up to 72 months
Assess effectiveness in routine treatment: Objective response rate (ORR)
ORR is defined as the proportion of patients achieving Complete Response (CR), Partial Response (PR), or Minor Response (MR) as best response.
Measured: 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)
DCR is defined as proportion of patients with Complete Response, Partial Response, Minor Response or Stable Disease as best response.
Measured: baseline, up to 72 months
Assess effectiveness in routine treatment: Best response
Best response is defined as Complete Response (CR), Partial Response (PR), Minor Response (MR), Stable Disease (SD), or Progressive Disease (PD))
Measured: baseline, up to 72 months
Assess effectiveness in routine treatment: Time to next intervention (TTNI)
Time to next intervention is defined as time from first administration of vorasidenib until initiation of next intervention (i.e., subsequent antineoplastic treatment, surgery, chemotherapy or radiotherapy) or death, whichever comes first.
Measured: baseline, up to 72 months
Assess drug safety: Incidence of (serious) adverse events ((S)AEs)
Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.
Measured: Baseline up to 30 days after vorasidenib treatment
Assess drug safety: Incidence of (serious) adverse drug reactions ((S)ADRs)
Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.
Measured: Baseline up to 30 days after vorasidenib treatment
Assess drug safety: Incidence of seizures reported as treatment-emergent adverse events (TEAEs)
Treatment-emergent adverse events (TEAE) are adverse events that were not present before medical treatment, or a pre-existing event that worsens in intensity or frequency during vorasidenib treatment and the following 30 days.
Measured: Baseline up to 30 days after vorasidenib treatment
Assess parameters of physicians' treatment decision making using a questionnaire
Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.
Measured: Baseline
Duration of treatment with vorasidenib
Describe treatment reality in detail: Duration of treatment with vorasidenib
Measured: baseline, up to 72 months
Frequency of treatment modifications with reasons
Describe treatment reality in detail: Frequency of treatment modifications with reasons
Measured: baseline, up to 72 months
Time to start of vorasidenib treatment after initial diagnosis
Describe treatment reality in detail: Time to start of vorasidenib treatment after initial diagnosis
Measured: Baseline
Time to start of vorasidenib treatment after surgery
Describe treatment reality in detail: Time to start of vorasidenib treatment after surgery
Measured: Baseline
Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)
Describe treatment reality in detail: Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)
Measured: baseline, up to 72 months
Anti-epileptic medication: Proportion of patients with anti-epileptic drug (AED) treatment at baseline
Proportion of patients with anti-epileptic drug treatment at baseline (i.e. 30 days prior treatment)
Measured: baseline, up to 72 months
Anti-epileptic medication: Proportion of patients with AED treatment during treatment
Proportion of patients with anti-epileptic drug treatment during treatment
Measured: baseline, up to 72 months
Anti-epileptic medication: Type of AED
Anti-epileptic medication during course of treatment
Measured: baseline, up to 72 months
Anti-epileptic medication: Doses of AED
Doses of anti-epileptic medication over the course of time
Measured: baseline, up to 72 months
Anti-epileptic medication: AED modifications
Type of anti-epileptic medication modifications
Measured: baseline, up to 72 months
Anti-epileptic medication: Reasons for AED modifications
Anti-epileptic medication modifications with reasons thereof
Measured: baseline, up to 72 months
Anti-epileptic medication: Frequency of patients under AED treatment after End of Treatment (EOT) of vorasidenib
Frequency of patients under AED treatment after EOT of vorasidenib (incl. dose)
Measured: from end of treatment to end of study, up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start8 Dec 2025
- Primary completionNov 2031 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240662
- Sponsor's protocol ID
- IOM-120529
- Acronym
- VIOLETA
- Status last verified
- Jan 2026
- First submitted
- 29 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany
- ClinicalTrials.gov ID
- NCT07240662
- Acronym / sponsor ID
- VIOLETA / IOM-120529
- Conditions
- Glioma
- Keywords
- WHO Grade 2, IDH-mutant, diffuse
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Participation in an interventional clinical trial
- Patient unable to consent
- Other contraindications according to current SmPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vorasideniboral, first-in-class, dual inhibitor of mIDH 1 and 2 | Drug | – |
Primary outcome
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
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.
30 secondary outcomes
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
Assess effectiveness in routine treatment: Best response
Time frame: baseline, up to 72 months
Assess effectiveness in routine treatment: Time to next intervention (TTNI)
Time frame: baseline, up to 72 months
Assess drug safety: Incidence of (serious) adverse events ((S)AEs)
Time frame: Baseline up to 30 days after vorasidenib treatment
Assess drug safety: Incidence of (serious) adverse drug reactions ((S)ADRs)
Time frame: Baseline up to 30 days after vorasidenib treatment
Assess drug safety: Incidence of seizures reported as treatment-emergent adverse events (TEAEs)
Time frame: Baseline up to 30 days after vorasidenib treatment
Assess parameters of physicians' treatment decision making using a questionnaire
Time frame: Baseline
Duration of treatment with vorasidenib
Time frame: baseline, up to 72 months
Frequency of treatment modifications with reasons
Time frame: baseline, up to 72 months
Time to start of vorasidenib treatment after initial diagnosis
Time frame: Baseline
Time to start of vorasidenib treatment after surgery
Time frame: Baseline
Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)
Time frame: baseline, up to 72 months
Anti-epileptic medication: Proportion of patients with anti-epileptic drug (AED) treatment at baseline
Time frame: baseline, up to 72 months
Anti-epileptic medication: Proportion of patients with AED treatment during treatment
Time frame: baseline, up to 72 months
Anti-epileptic medication: Type of AED
Time frame: baseline, up to 72 months
Anti-epileptic medication: Doses of AED
Time frame: baseline, up to 72 months
Anti-epileptic medication: AED modifications
Time frame: baseline, up to 72 months
Anti-epileptic medication: Reasons for AED modifications
Time frame: baseline, up to 72 months
Anti-epileptic medication: Frequency of patients under AED treatment after End of Treatment (EOT) of vorasidenib
Time frame: from end of treatment to end of study, up to 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact iOMEDICO (+49761152420, information@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.