A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
3상
조기 종료
NCT04161885
| 대상 질환 | Acute Myeloid Leukemia, Cancer |
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| 임상 단계 | 3상 |
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| 스폰서 | AbbVie |
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| 상태 | 조기 종료 |
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| 참여자 수 | 465 명 |
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| 중재(약물) | Venetoclax, Azacitidine, Best Supportive Care (BSC) |
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| 시작일 | 2020년 2월 26일 |
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| 완료일 | 2025년 9월 23일 |
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| 결과 공개일 | 2026년 6월 4일 |
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요약
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
Up to 28 days · Participants
| Part 1: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD | 3 Participants |
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| Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD | 0 Participants |
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Overall Survival (OS) (Part 2)
Up to approximately 41 months · months
| Part 2: Best Supportive Care | NA months |
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| Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD | NA months |
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| Stratified Hazard Ratio | 1.2 (95% CI 0.81–1.77) |
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