Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
3상
진행 중(모집 완료)
NCT03173248
| 대상 질환 | Newly Diagnosed Acute Myeloid Leukemia, Untreated AML, AML Arising From Myelodysplastic Syndrome, Leukemia, Myeloid, Acute |
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| 임상 단계 | 3상 |
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| 스폰서 | Institut de Recherches Internationales Servier |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 146 명 |
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| 중재(약물) | AG-120, Azacitidine |
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| 시작일 | 2017년 6월 26일 |
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| 완료일 | 2021년 3월 18일 |
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| 결과 공개일 | 2023년 3월 23일 |
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요약
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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