Status:
NOT_YET_RECRUITING
A Multicentre, Retrospective-prospective Real-world Study: to Evaluate the Effectiveness and Safety of Vorasidenib in Patients With Isocitrate Dehydrogenase IDH1/2 Mutant Grade 2 Astrocytoma or Oligodendroglioma (VICTORIA Study)
Lead Sponsor:
Servier (Tianjin) Pharmaceutical Co. LTD.
Collaborating Sponsors:
Institut de Recherches Internationales Servier (I.R.I.S.)
Hainan Boyan Medical Research Co. Ltd.
Conditions:
Gliomas
Eligibility:
All Genders
12+ years
Brief Summary
The goal of this Study is to evaluate the effectiveness and safety of Vorasidenib in Patients with Isocitrate dehydrogenase IDH1/2 mutant Grade 2 astrocytoma or oligodendroglioma, primary purposeis to...
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.
- 6\) 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:
- 1\) Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06969352
Start Date
June 1 2025
End Date
February 1 2027
Last Update
May 13 2025
Active Locations (3)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
West China Lecheng Hospital Sichuan University
Qionghai, Hainan, China
3
West China Hospital Sichuan University
Chengdu, Sichuan, China