[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611444":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":37,"collaborators":7,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":7,"enrollmentInfo":49,"targetDuration":7,"studyType":52,"phases":7,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"iOMEDICO AG","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","Vorasidenib","oral, first-in-class, dual inhibitor of mIDH 1 and 2",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"iOMEDICO","CONTACT","+49761152420","information@iomedico.com",[20],{"facility":21,"status":22,"city":23,"state":7,"zip":7,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg","RECRUITING","Heidelberg","Germany","DE",{"type":27,"coordinates":28},"Point",[29,30],8.69079,49.40768,{"lat":30,"lon":29},[33],{"name":34,"role":16,"phone":35,"phoneExt":7,"email":36},"Wolfgang Wick, Prof. Dr.","+496221567075","nct.neuroonko@med.uni-heidelberg.de",{"type":38,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100611444","vorasidenib-in-cns-who-grade-2-idh-mutant-diffuse-glioma-100611444",false,"NCT07240662","Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma","Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma: A Multicenter, Prospective, Non-interventional Study in Germany","VIOLETA","Inclusion Criteria:\n\n* Age ≥18 years\n* WHO grade 2 astrocytoma or oligodendroglioma\n* Presence of IDH1- or IDH2-mutation\n* Surgical intervention\n* No immediate need of radiotherapy or chemotherapy according to the treating physician\n* Decision for treatment with vorasidenib as per current SmPC\n* Signed written informed consent\\*\n* Willingness to participate in Patient-Reported Outcome (PRO) assessment in German language\n* 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\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial\n* Patient unable to consent\n* Other contraindications according to current SmPC.","ALL","18 Years",{"count":50,"type":51},150,"ESTIMATED","OBSERVATIONAL","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.",[55],"Glioma",[57,58,59],"WHO Grade 2","IDH-mutant","diffuse","2026-01-07",{"date":62,"type":63},"2026-01-09","ACTUAL",{"date":65,"type":63},"2025-12-08",{"date":67,"type":51},"2032-01",{"name":5,"class":6},1]