Идёт набор NCT07240662

Vorasidenib in CNS WHO Grade 2 IDH-mutant Diffuse Glioma

— Наблюдательное Glioma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Vorasidenib.
Кому может быть актуально: Состояния в реестре: Glioma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Вмешательства

Препарат Vorasidenib
oral, first-in-class, dual inhibitor of mIDH 1 and 2

Первичные конечные точки

Evaluate Quality of Life (QoL) by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire over the course of treatment [Срок оценки: baseline, up to 72 months]

Вторичные конечные точки (12)

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 [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: Proportion of patients with baseline seizure activity [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: event rate of seizures [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: event rate of seizures with loss of consciousness [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: incidence rate of seizures with loss of consciousness [Срок оценки: baseline, up to 72 months]
Assess seizure activity and severity at baseline and during treatment: Change from baseline of seizures [Срок оценки: 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 [Срок оценки: baseline, up to 72 months]
Assess effectiveness in routine treatment: Progression-free survival [Срок оценки: baseline, up to 72 months]
Assess effectiveness in routine treatment: Overall Survival (OS) [Срок оценки: baseline, up to 72 months]
Assess effectiveness in routine treatment: Objective response rate (ORR) [Срок оценки: 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) [Срок оценки: baseline, up to 72 months]

Критерии участия

Критерии включения

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