Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
第3相
実施中（募集終了）
NCT03173248
| 対象疾患 | Newly Diagnosed Acute Myeloid Leukemia, Untreated AML, AML Arising From Myelodysplastic Syndrome, Leukemia, Myeloid, Acute |
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| 相 | 第3相 |
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| スポンサー | Institut de Recherches Internationales Servier |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 146 名 |
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| 介入（薬剤） | AG-120, Azacitidine |
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| 開始日 | 2017年6月26日 |
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| 完了日 | 2021年3月18日 |
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| 結果公開日 | 2023年3月23日 |
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概要
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Event-Free Survival (EFS)
Up to Week 24 · months
| AG-120 + Azacitidine | 0.03 months |
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| Placebo + Azacitidine | 0.03 months |
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| p-value | 0.0011 |
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| Hazard Ratio (HR) | 0.33 (95% CI 0.16–0.69) |
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