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)
Фаза 3
Прекращено
NCT04161885
| Заболевание | Acute Myeloid Leukemia, Cancer |
|---|
| Фаза | Фаза 3 |
|---|
| Спонсор | AbbVie |
|---|
| Статус | Прекращено |
|---|
| Участники | 465 участн. |
|---|
| Вмешательство | Venetoclax, Azacitidine, Best Supportive Care (BSC) |
|---|
| Дата начала | 26.02.2020 |
|---|
| Дата завершения | 23.09.2025 |
|---|
| Публикация результатов | 4.06.2026 |
|---|
Кратко
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 |
|---|
| Part 1: Venetoclax 200 mg QD 14 Days + Azacitidine 20 mg/m^2 QD | 0 Participants |
|---|
Overall Survival (OS) (Part 2)
Up to approximately 41 months · months
| Part 2: Best Supportive Care | NA months |
|---|
| Part 2: Venetoclax 200 mg QD 28 Days + Azacitidine 20 mg/m^2 QD | NA months |
|---|
| Stratified Hazard Ratio | 1.2 (95% CI 0.81–1.77) |
|---|
Открыть в BENITIONS
Открыть на ClinicalTrials.gov
Все исследования
Страница обобщает открытые данные ClinicalTrials.gov. Это не медицинская и не инвестиционная рекомендация. Обратитесь к врачу.