Phase II Trial of Venetoclax in Combination With Azacitidine and CAG as Induction Therapy in Patients With Refractory/Relapse Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and CAG as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia.
详细描述
This is an open-label, multicenter, phase II clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (VA) and CAG (G-CSF priming, low dose cytarabine, and aclarubicin) as induction regimen in Patients with Refreactory/Relapse Acute Myeloid Leukemia(AML).
Previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo AML patients with high complete remission rates and good tolerance. Our preliminary results suggest that venetoclax in combination with azacitidine and CAG are well tolerated and effective for patients who were diagnosed with refreactory/relapse AML. Thus, this phase II clinical trial is going to further explore its efficacy and safety. It is expected that about 42 patients will take part in this trial.
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
盲法说明
Open lable
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
- •Patients ≥ 18 years old and ≤ 65 years old
- •Refractory/Relapse AML patients according to 2016 World Health Organization (WHO) classification;
- •Eastern Cooperative Oncology Group (ECOG) Performance status score less than 3;
- •Liver function: Total bilirubin ≦2 upper limit of normal (ULN); aspartate aminotransferase (AST) ≦3 ULN; alanine aminotransferase (ALT)≦3 ULN
- •Renal function：Ccr（Creatinine Clearance Rate） ≧30 ml/min; Scr (serum creatinine) ≦2 ULN
- •Heart function: left ventricular ejection fraction ≧45%
- •Patients must participate in this clinical trial voluntarily and sign an informed consent form.
排除标准
- •Other diseases；
- •AML with central nervous system (CNS) infiltration；
- •Patients have received prior CAG or VA regimen before；
- •Patients with a life expectancy <3 months
- •Patients with uncontrolled active infection;
- •HIV infection;
- •Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. b) An active second cancer that requires treatment within 6 months of study entry
- •Female who are pregnant, breast feeding or childbearing potential.
- •Patients deemed unsuitable for enrollment by the investigator;
研究组 & 干预措施
VACAG（Venetoclax Combined with Azacitidine and CAG）regimen
Participants will receive induction as azacitidine on days 1-7, venetoclax aily on days 1-28, cytarabine q12h on days 1-7, aclacinomycin on days 1,3,5,7, and granulocyte colony-stimulating factor on days 0-8. Participants will receive second induction if not reach complete remission.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 2 cycles from the start of VACAG regimen (each cycle is 28 days)
The overall remission rate (ORR) was defined as the percentage of patients who achieved complete remission (CR), complete remission with incomplete count recovery (CRi), or morphologic leukemia free state (MLFS) per the International Working Group criteria for AML.
次要结局
- Rate of Minimal Residual Disease (MRD) negativity(up to 2 years)
- Overall survival(up to 2 years)
- Duration of myelosuppression(up to 2 years)
- Incidence of Treatment-Emergent Adverse Events(up to 2 years)
- Leukaemia-free survival(up to 2 years)