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
Фаза 3
Идёт, набор закрыт
NCT03182244
| Заболевание | AML With FLT3 Mutation |
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| Фаза | Фаза 3 |
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| Спонсор | Astellas Pharma Inc |
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| Статус | Идёт, набор закрыт |
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| Участники | 276 участн. |
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| Вмешательство | Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF |
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| Дата начала | 25.10.2017 |
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| Дата завершения | 25.12.2023 |
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| Публикация результатов | 14.01.2025 |
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Кратко
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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