Phase
Condition
Gliomas
Oligodendroglioma
Astrocytoma
Treatment
Vorasidenib
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion and exclusion criteria for treatment group
Patients will be included if they meet all the following criteria:
Patients (female and male) aged ≥ 12 years at enrolment.
Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation
Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection).
Patients with evaluable disease based on the most recent MRI in the opinion of the treating physician. A measurable non-enhanced lesion is defined as at least one target lesion with dimensions of ≥1 cm × ≥1 cm (in two dimensions). Confirmed by a centralized IRC as minimal, non-nodular, and non-measurable enhancement.
The PI evaluates based on the Vorasidenib label and patients is willing plan to receive Vorasidenib
Be able to understand and provide written informed consent if the patient is 18 years or older, or if the patient is a minor (12 years or older and under 18 years), both the patient and their legal representative must sign the informed consent.
Patients who meet at least one of the following exclusion criteria will not be included in the study:
Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.
Patients with any contrindications to Vorasidenib
Inclusion and exclusion criteria for the external control group
Patients will be included if they meet all the following criteria:
Patients (female and male) aged ≥ 12 years at the index date.
Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation
Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection) before the index date.
Since the index date, the patient must have undergone at least two magnetic resonance imaging (MRI) scans with an interval of at least 6 months (±30 days), showing measurable or evaluable non-enhancing lesions. Measurable non-enhancing lesions are defined as at least one target lesion that is ≥1 cm × ≥1 cm (two-dimensional). These lesions must be centrally confirmed by the IRC (Independent Review Committee) as small, non-nodular, and nonmeasurable enhancing lesions.
- Must have at least 6 months (±30 days) follow-up historical data since the index date without any treatment in this period.
Patients who meet at least one of the following exclusion criteria will not be included in the study:
- Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.
Study Design
Connect with a study center
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing
ChinaSite Not Available
West China Lecheng Hospital Sichuan University
Qionghai, Hainan
ChinaSite Not Available
West China Hospital Sichuan University
Chengdu, Sichuan
ChinaSite Not Available

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