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)
第3相
早期終了
NCT04161885
| 対象疾患 | Acute Myeloid Leukemia, Cancer |
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| 相 | 第3相 |
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| スポンサー | AbbVie |
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| ステータス | 早期終了 |
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| 参加者数 | 465 名 |
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| 介入（薬剤） | Venetoclax, Azacitidine, Best Supportive Care (BSC) |
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| 開始日 | 2020年2月26日 |
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| 完了日 | 2025年9月23日 |
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| 結果公開日 | 2026年6月4日 |
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概要
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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BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
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