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Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

Recruitingn/aAges 18 Years - anyAlliOMEDICO AG
NCT07240662 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vorasidenib
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Where

1 site
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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