Maintenance Venetoclax Based Therapy Post Complete Remission in AML Fit Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Disease free survival DFS
研究概览
简要总结
this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.
详细描述
this study is a prospective,phase III , randomized ,open , interventional study include young fit patients who will receive maintenance venetoclax +subcutaneous cytarabine as bridge for BMT or if BMT will be delayed
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 18 - 60 years . Patients who are not eligible for immediate bone marrow transplantation. Newly diagnosed AML patients who attained CR after 1st line. Refractory / recurrant AML patients who attained CR after 2nd line .
排除标准
- •Patients not on CR . Age : younger than 18 or older than 60 . Patients not eligible for bone marrow transplation
研究组 & 干预措施
Arm A
will receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC
干预措施: SC cytarabine +Venetoclax (Drug)
结局指标
主要结局
Disease free survival DFS
时间窗: 24 months
time from complet remission to relapse or death from any cause in AML fit patients receiving maintenance SC cytarabine plus venetoclax after intensive chemotherapy
次要结局
未报告次要终点
研究者
Eman Ibrahim Abdelshakour
Assistant lecturer
Sohag University