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)
3期
提前终止
NCT04161885
| 适应症 | Acute Myeloid Leukemia, Cancer |
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| 分期 | 3期 |
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| 申办方 | AbbVie |
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| 状态 | 提前终止 |
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| 受试者人数 | 465 人 |
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| 干预（药物） | Venetoclax, Azacitidine, Best Supportive Care (BSC) |
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| 开始日期 | 2020年2月26日 |
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| 完成日期 | 2025年9月23日 |
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| 结果公布日 | 2026年6月4日 |
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摘要
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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