NCT07264010尚未招募2 期
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 87
- 主要终点
- Molecular response rate after three courses of treatment
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of sorafenib combined with venetoclax as pre-emptive therapy strategy for measurable residual disease persisting acute myeloid leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of informed consent form;
- •Liver and kidney function: Blood bilirubin ≤ 35 μ mol/L, AST/ALT < 2 times the upper limit of normal, blood creatinine ≤ 150 μ mol/L;
- •Normal heart function (EF ≥ 50%, NYHA I/II);
- •Physical condition score 0-2 (ECOG score);
- •Non pregnant and lactating women. For all women of childbearing age, a pregnancy test must be conducted to determine hCG levels in order to exclude pregnancy status;
- •For all men of childbearing age, contraceptive measures must be taken during sorafenib treatment until 3 months after discontinuation.
排除标准
- •Acute promyelocytic leukemia;
- •Hematological non-remisssion or recurrence;
- •Uncontrolled infection or grade 3-4 graft-versus-host disease (GVHD);
- •Allergies or contraindications to any of the drugs involved in the protocol;
- •Severe organ dysfunction such as heart, liver, kidneys, lungs, etc.
研究组 & 干预措施
SORA+VEN
Experimental
sorafenib combined with venetoclax
干预措施: Sorafenib (SORA) (Drug)
SORA+VEN
Experimental
sorafenib combined with venetoclax
干预措施: Venetoclax (VEN) (Drug)
结局指标
主要结局
Molecular response rate after three courses of treatment
时间窗: 1 year
After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
次要结局
- MRD negative rates after three courses of treatment(1 year)
- Event-free survival (EFS)(3 year)
- Overall survival (OS)(3 year)
- Cumulative incidence of relapse (CIR)(3 year)
- Adverse events (AEs)(3 year)
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