A Study of Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy in Patients With Acute Myeloid Leukemia Who Had Relapsed/Refractory Disease or Positive Minimal Residual Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 52
- 主要终点
- Complete remission rate
研究概览
简要总结
Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.
详细描述
Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. To date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory AML are scarce and heterogenous. In this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
- •The toxic and side effects caused by the last treatment should be recovered.
- •Eastern Cooperative Oncology Group score of 0 to 3 points.
- •The organ function is intact.
- •Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (Upper Limit of Normal).
- •Creatinine≤1.5×ULN.
- •Bilirubin≤1.5×ULN.
- •The expected survival period is at least 12 weeks.
- •Non-pregnant, non-breastfeeding women.
排除标准
- •Suffering from other untreated or unrelieved malignant tumors within 2 years.
- •Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
- •Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association [NYHA] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
- •Patients who are unwilling or unable to comply with the protocol.
- •Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
venetoclax + Hypomethylation agent + low-dose cytarabine treatment group
patients treated with venetoclax combined with decitabine/azacytidine and low-dose cytarabine
干预措施: Venetoclax, Decitabine, Azacytidine, Cytarabine (Drug)
结局指标
主要结局
Complete remission rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Complete minimal residual disease (MRD) Response Rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD negative or MRD \< 0.01%
MRD Response Rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with MRD \< 0.1% detectable by multicolor flow cytometry
次要结局
- Adverse events(start of treatment to 2 weeks after end of treatment)
- Relapse-Free Survival(24 months)
- Overall Survival(24 months)
- Duration of response(24 months)
研究者
Xiao-Ning Gao
Principal Investigator
Beijing 302 Hospital