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

简要总结

主要结局

次要结局

• 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(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: event rate of seizures(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures with loss of consciousness(baseline, up to 72 months)
• Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures(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(baseline, up to 72 months)
• Assess effectiveness in routine treatment: Progression-free survival(baseline, up to 72 months)
• Assess effectiveness in routine treatment: Overall Survival (OS)(baseline, up to 72 months)
• Assess effectiveness in routine treatment: Objective response rate (ORR)(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)(baseline, up to 72 months)
• Assess effectiveness in routine treatment: Best response(baseline, up to 72 months)
• Assess effectiveness in routine treatment: Time to next intervention (TTNI)(baseline, up to 72 months)
• Assess drug safety: Incidence of (serious) adverse events ((S)AEs)(Baseline up to 30 days after vorasidenib treatment)
• Assess drug safety: Incidence of (serious) adverse drug reactions ((S)ADRs)(Baseline up to 30 days after vorasidenib treatment)
• Assess drug safety: Incidence of seizures reported as treatment-emergent adverse events (TEAEs)(Baseline up to 30 days after vorasidenib treatment)
• Assess parameters of physicians' treatment decision making using a questionnaire(Baseline)
• Duration of treatment with vorasidenib(baseline, up to 72 months)
• Frequency of treatment modifications with reasons(baseline, up to 72 months)
• Time to start of vorasidenib treatment after initial diagnosis(Baseline)
• Time to start of vorasidenib treatment after surgery(Baseline)
• Frequency of distinct subsequent antineoplastic therapies (systemic therapies including substances, surgeries, radiotherapies)(baseline, up to 72 months)
• Anti-epileptic medication: Proportion of patients with anti-epileptic drug (AED) treatment at baseline(baseline, up to 72 months)
• Anti-epileptic medication: Proportion of patients with AED treatment during treatment(baseline, up to 72 months)
• Anti-epileptic medication: Type of AED(baseline, up to 72 months)
• Anti-epileptic medication: Doses of AED(baseline, up to 72 months)
• Anti-epileptic medication: AED modifications(baseline, up to 72 months)
• Anti-epileptic medication: Reasons for AED modifications(baseline, up to 72 months)
• Anti-epileptic medication: Frequency of patients under AED treatment after End of Treatment (EOT) of vorasidenib(from end of treatment to end of study, up to 72 months)