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)

Last updated: May 7, 2025
Sponsor: Servier (Tianjin) Pharmaceutical Co. LTD.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Gliomas

Oligodendroglioma

Astrocytoma

Treatment

Vorasidenib

Clinical Study ID

NCT06969352
S095032-235
  • Ages > 12
  • All Genders

Study 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 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).

Eligibility Criteria

Inclusion

Inclusion and exclusion criteria for treatment group

Patients will be included if they meet all the following criteria:

  1. Patients (female and male) aged ≥ 12 years at enrolment.

  2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation

  3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection).

  4. 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.

  5. The PI evaluates based on the Vorasidenib label and patients is willing plan to receive Vorasidenib

  6. 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:

  1. Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.

  2. 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:

  1. Patients (female and male) aged ≥ 12 years at the index date.

  2. Patients with tissue-confirmed diagnoses of Grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutation

  3. Have undergone at least one prior glioma surgery (biopsy, subtotal resection, or complete resection) before the index date.

  4. 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.

  1. 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.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Vorasidenib
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • West China Lecheng Hospital Sichuan University

    Qionghai, Hainan
    China

    Site Not Available

  • West China Hospital Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.