A Phase 3, Randomized, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Decitabine Combined With HAAG Regimen in Newly Diagnosed Acute Myeloid Leukemia Patients Younger Than 60 Years
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of DAC combined with HAAG regimen in the induction treatment of newly diagnosed AML patients younger than 60 years.
详细描述
This is a phase 3, randomized, controlled, multi-center study in newly diagnosed AML patients younger than 60. The patients will be randomized to receive either DAC combined with HAAG or IA regimen in the induction treatment.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia.
- •ECOG score: 0-
- •Treatment related or secondary AML.
- •No history of previous chemotherapy or target therapy.
- •Provide informed consent.
排除标准
- •Patients are pregnant or lactating.
- •Patients have acute promylocytic leukemia or chronic myeloid leukemia in blast crisis.
- •Patients with another malignant disease.
- •Patients with uncontrolled active infection.
- •Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- •Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
- •Patients with creatinine clearance rate < 50ml/min.
- •Patients with active hepatitis B or hepatitis C infection.
- •Patients with HIV infection.
- •Patients with other commodities that the investigators considered not suitable for the enrollment.
研究组 & 干预措施
Decitabine combined with HAAG
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
干预措施: Decitabine plus HAAG regimen (Drug)
IA Regimen
This cohort will determine the safety and efficacy of decitabine combined with HAAG regimen in the newly diagnosed AML patients younger than 60.
干预措施: Idarubicine plus Cytarabine regimen (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Day 28-35 of induction course
ORR includes complete response (CR), CRi and PR. CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
次要结局
- Overall survival (OS)(3 years)
- Leukemia-free survival (LFS)(3 years)
- Cumulative incidence of relapse(CIR)(3 years)
- Number of adverse events(2 years)