Gliomas
Conditions
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 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).
Interventions
DRUGVorasidenib
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.
Sponsors
Institut de Recherches Internationales Servier (I.R.I.S.)
Hainan Boyan Medical Research Co. Ltd.
Fantastic Bioimaging Co., Ltd.
Clinical TrialService (Guangzhou) Co.,Ltd
Servier (Tianjin) Pharmaceutical Co. LTD.
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint | at 6 months after the index date | TGR at 6 months after the index date\*. TGR is defined as percentage change in tumour volume from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy endpoint | 12 months after the index date of the last required sample patient | TTNI, TTNI is defined as the time from enrolment to the initiation of the first subsequent anticancer therapy or death due to any causes whichever occurs earlier. |
Countries
China
Contacts
Primary ContactQiaohui KANG
Outcome results
None listed