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)

Sponsor
Servier (Tianjin) Pharmaceutical Co. LTD.
Study ID
NCT06969352
Status
Active Not Recruiting

Conditions

  • Gliomas

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorasidenib — DRUG
    Treatment group: recommended dosage in adults and paediatric patients 12 years of age and older: * For patients weighing at least 40 kg: 40 mg, orally, once daily. * For patients weighing less than 40 kg: 20 mg, orally, once daily.

Study Details

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 evaluate the efficectiveness of Vorasidenib in glioma patients treated in routine clinical practice in In China, patients aged 12 and above with grade II or higher astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. The main question it aims to answer is: if this trend is consistent with the efficacy observed in the INDIGO study, and there is not any new safety signal compared to previous research data? Researchers will compare to no treatment. Participants is not mandatory for a formal visit as it is a real-word study.However, due to the fact that patients will be treated with new drugs and need to collect data on major efficacy, regular visits should be performed in routine clinical practice. This study is a multicenter, retrospective-and prospective real-world study, There are treatment group (Vorasidenib) and external control group (untreated after surgery).

Key Dates

First listed
May 13, 2025
Start date
Sep 2, 2025
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
62 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment group(Vorasidenib)
    As a real-world study, in principle, a formal visit is not mandatory. However, due to the fact that patients will be treated with new drugs and need to collect data on major efficacy, regular visits should be performed in routine clinical practice.
  • No Intervention: external control group (untreated after surgery)
    Eligible patients are those who have MRI data available for analysis after glioma surgery (including biopsy, subtotal resection, or total resection) and at least one additional MRI scan available for analysis within the following 6 months after the index data During this period, the eligible patients who have not undergone radiotherapy or chemotherapy after resection will be included in the external control arm.

Primary Outcome Measure

Primary efficacy endpoint [ Time Frame: at 6 months after the index date ]

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