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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) (VICTORIA)
Code de protocole Servier:
S095032-235
Sponsor:
Servier (Tianjin) Pharmaceutical Co. LTD.
Identifiant Clinicaltrials.gov:
NCT06969352
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Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Nom:
Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone:
+33 1 55 72 60 00
L'étude a 3 centres
Description de l'étude
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).
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).
Titre officiel: 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)
Indications
Gliomas
Interventions / Traitements
Le ou les traitements administrés aux participants à l'étude.
- Vorasidenib
Autres numéros d'identification
Autres numéros d'identification sous lesquels l'étude peut être connue.
- S095032-235
Critères d'éligibilité
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Ceux-ci comprennent les critères d'inclusion et les critères d'exclusion. Parmi ces critères, on peut citer l'état de santé général d'une personne ou les traitements antérieurs qu'elle a suivis.
Age éligible pour l’étude
12 ans et plus
(Enfant, Adulte, Adulte plus âgé)
Sexe
Homme/FemmeAccepte les volontaires en bonne santé
Non- 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.
- 1. Patients who received radiotherapy, chemotherapy or other IDH inhibitor for Glioma before enrolment.
- 2. Patients with any contrindications to Vorasidenib
- 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.
- 1) Patients who received radiotherapy, chemotherapy or other IDH inhibitors for Glioma before the index date.
Comment l'étude est-elle conçue ?
Allocation
Comment les participants sont répartis dans différents groupes. La répartition peut être aléatoire (randomisée) ou prédéterminée (non randomisée). Randomisée signifie que les participants sont répartis de manière aléatoire dans leur groupe/branche.
Modèle d'étude interventionnelle
Comment les traitements sont administrés et testés dans le cadre d'une étude.
Parallèle
Une étude parallèle compare deux groupes ou plus en même temps, chaque groupe recevant un traitement différent. Les chercheurs comparent ensuite les résultats afin de déterminer quel traitement est le plus efficace.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Expérimental:
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.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Traitement:
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.
Groupe de participants / Bras de traitement
Un groupe de participants à l'étude qui reçoivent le même traitement ou la même intervention.
Pas d'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.
Intervention / Traitement
Le ou les traitements administrés aux participants à l'étude.
Mots clés
Autres termes
Glioma
Glossaire
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