A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 788
- 主要终点
- Disease-Free Survival
研究概览
简要总结
This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg/m²/day on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML per WHO 2022 or ICC criteria, or MDS/AML (10-20% blasts) per ICC
- •Age ≥14 and <75 years
- •ECOG performance status 0-2
- •First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation
- •Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g/m² per cycle)
- •Time from first CR/CRi to enrollment ≤10 months, and time from last treatment to enrollment ≤3 months
- •MRD-negative or low-level MRD detectable; MRD-positive patients are excluded
- •Signed informed consent
排除标准
- •Acute promyelocytic leukemia with PML-RARA
- •AML with BCR-ABL
- •Active central nervous system involvement
- •Prior allogeneic hematopoietic stem cell transplantation
- •Planned allogeneic HSCT within 6 months
- •Deemed unsuitable by investigator
研究组 & 干预措施
VA
Azacitidine 50 mg/m²/day on days 1-5 + Venetoclax 400 mg on days 1-7, every 6 weeks for 12 cycles
干预措施: Azacitidine (Drug)
VA
Azacitidine 50 mg/m²/day on days 1-5 + Venetoclax 400 mg on days 1-7, every 6 weeks for 12 cycles
干预措施: Venetoclax (Drug)
AZA
Azacitidine 50 mg/m²/day on days 1-5, every 6 weeks for 12 cycles
干预措施: Azacitidine (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: up to 2 years
次要结局
- Relapse-Free Survival (RFS)(up to 2 years)
- DFS-MRD(Up to 2 years)
- RFS-MRD(Up to 2 years)
- Complete Remission Duration (CRd)(up to 1 year)
- Overall Survival (OS)(up to 2 years)
- Cumulative Incidence of Relapse (CIR)(Up to 5 years)
- CIR-MRD(up to 5 years)
- MRD Negativity Conversion Rate(up to 5 years)