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)

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	12 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06969352
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Servier (Tianjin) Pharmaceutical Co. LTD.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gliomas

Arms & Interventions

Arms

: 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.

: 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.

Interventions

Drug: - Vorasidenib

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Address

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing,

Site Contact

Xiaohui Ren

[email protected]

+8618500350333

Qionghai, Hainan, China

Status

Address

West China Lecheng Hospital Sichuan University

Qionghai, Hainan,

Site Contact

Yanhui Liu

[email protected]

+8618500350333

West China Hospital Sichuan University, Chengdu, Sichuan, China

Status

Address

West China Hospital Sichuan University

Chengdu, Sichuan,

Site Contact

Yanhui LIU

[email protected]

+8618500350333

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