NCT06162325Enrolling By Invitation不适用
The Efficacy and Safety of Venetoclax in Combination With Standard Induction and Consolidation Chemotherapy in Newly Diagnosed Young Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
The goal of this observational study is to to evaluate the efficacy and safety of Venetoclax in combination with DA60(daunorubicin 60 mg/m2/d for 3 days, and cytarabine 100 mg/m2 every 12 h for 7 days) induction and HD-AraC(cytarabine 3 g/m2 every 12 h for 3 days) consolidation, in young patients with newly diagnosed acute myeloid leukemia (AML).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, morphologically documented AML based on the World Health Organization (WHO) 2016 classification.
- •Age ≥ 18 years and ≤ 59 years
- •Have been treat with the "venetoclax in combination with standard induction and consolidation chemotherapy" therapy, and in follow-up.
- •Be comprehensive of the research, and able to provide informed consent.
排除标准
- •Diagnosis of acute promyelocytic leukemia (APL).
- •Prior treatment for AML, except for: leukapheresis, hydroxyurea, and growth factor/cytokine.
- •Unable to understand or participate.
结局指标
主要结局
Disease-free survival (DFS)
时间窗: Assess up to 24 months.
DFS is calculated from the date of remission (inclusive of CR and CRi) to the date of relapse, death from any cause, or last follow-up.
次要结局
- Complete remission (CR) rate(On Day 21 (window Day 21 to Day 35), a bone marrow aspirate specimen will be collected for morphology and pathology.)
- Rate of minimal residual disease (MRD) negativity(MRD will be tested after every cycle of therapy and during follow-up.)
- Overall survival (OS)(Assess up to 24 months.)
研究者
研究点 (1)
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