ChiCTR2500111062尚未招募3 期
Maintenance Venetoclax Based Therapy Post Complete Remission In AML Fit Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
The aim of this study is to 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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 60（—）
- 性别
- All
入选标准
- •1-Age : 18 - 60 years .
- •2-Patients who are not eligible for immediate bone marrow transplantation.
- •3-Newly diagnosed AML patients who attained CR after 1st line.
- •4-Refractory / recurrant AML patients .
排除标准
- •1-Patients not on CR .
- •2-Age : younger than 18 or older than 60
- •3-Patients not eligible for bone marrow transplation
研究组 & 干预措施
venetoclax group
placebo group
结局指标
主要结局
disease free survival
时间窗: 12 months after treatment
次要结局
- overall survival
- quality of life and side effect
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of Venetoclax Co-Administered with Low Dose Cytarabine Versus Low Dose Cytarabine in Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive ChemotherapyAcute Myeloid Leukemia2024-513630-37-00AbbVie Deutschland GmbH & Co. KG1
尚未招募
2 期
PreVent-ACaLLChronic Lymphocytic Leukemia2024-511072-33-00Rigshospitalet50
招募中
2 期
Venetoclax plus azacitidine versus standard intensive chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML) and NPM1 mutations eligible for intensive treatment (VINCENT)Acute myeloid leukemia2024-515267-59-00Technische Universitaet Dresden146
进行中（未招募）
不适用
Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in ND Int-and H-risk MDS or CMMLCMMLNCT07318662Guangdong Provincial People's Hospital224
招募中
3 期
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy2023-507221-42-00AbbVie Deutschland GmbH & Co. KG41