Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
3期
进行中（已停止招募）
NCT03173248
| 适应症 | Newly Diagnosed Acute Myeloid Leukemia, Untreated AML, AML Arising From Myelodysplastic Syndrome, Leukemia, Myeloid, Acute |
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| 分期 | 3期 |
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| 申办方 | Institut de Recherches Internationales Servier |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 146 人 |
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| 干预（药物） | AG-120, Azacitidine |
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| 开始日期 | 2017年6月26日 |
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| 完成日期 | 2021年3月18日 |
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| 结果公布日 | 2023年3月23日 |
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摘要
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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