A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation
3期
进行中（已停止招募）
NCT03182244
| 适应症 | AML With FLT3 Mutation |
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| 分期 | 3期 |
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| 申办方 | Astellas Pharma Inc |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 276 人 |
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| 干预（药物） | Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF |
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| 开始日期 | 2017年10月25日 |
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| 完成日期 | 2023年12月25日 |
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| 结果公布日 | 2025年1月14日 |
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摘要
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Overall Survival (OS)
From the date of randomization up to the date of death (up to approximatley 74 months) · months
| Gilteritinib | 10.3 months |
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| Salvage Chemotherapy | 5.4 months |
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| p-value | 0.00152 |
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| Hazard Ratio (HR) | 0.612 (95% CI 0.451–0.832) |
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