To Evaluate Safety and Efficacy of Azacitidine Combination With Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients：A Multicenter, Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.
详细描述
The Study Drug:
Azacitidine is a DNA Demethylated drug, which is approvd for treatment of elderly AML patients Venetoclax targets the anti-apoptotic protein Bcl-2 and the process of oxidative phosphorylation to induce apoptosis of leukemia cells and exhibits anti-tumor activity.
Study Group:
single arm: AZA plus Venetoclax
Study Drug Administration:
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age 45 to 65 years old,both male and female
- •2.Be able to understand and sign informed consent
- •3.Untreated AML patients (non-APL) diagnosed according to the 2016 World Health Organization (WHO) classification and diagnostic criteria for acute myeloid leukemia
- •4.Patients with an ECOG performance status 0,1,2 or 3
- •5.Expected survival time≥3 months
- •6.Laboratory indicators meet the following standards:
- •Bilrubin, ALT and AST were all less than 3 times the upper limit of normal within 7 days before the first day of treatment
- •Serum creatinine clearance rate is greater than 30ml/min
排除标准
- •1.patients participating in other interventional or observational clinical studies currently
- •2.Patients has a history of myeloproliferative neoplasm [MPN]
- •3.Patients with acute promyelocytic leukemia
- •4.Active CNS involvement in patients with acute myeloid leukemia
- •5.Patients with active hepatitis B or C, HIV infection before enrollment
- •6.Cardiovascular status of patients evaluate by NYHA classification method > 2
- •7.Patients have chronic respiratory disease requiring continuous oxygen treatment, or any sitiuation investigator believes will adversely affect this study (including renal, neurological, psychiatric, endocrine, metabolic, immune, hepatic, cardiovascular disease and known history of allergy to any study drug)
- •8.Patients suffering from malabsorption syndrome or other diseases that prevent the enteral route of administration
- •9.patients present with an uncontrolled systemic infection (viral, bacterial, or fungal)
- •10.Patients with a history of other malignancies within 2 years before enrollment, except for the following cases:
- •Adequately treated carcinoma in situ of the cervix or carcinoma of the breast
- •Basal cell carcinoma or localized squamous cell carcinoma of skin
研究组 & 干预措施
Azacitidine combined with Venetoclax
Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission.
Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.
干预措施: Azacitidine (Drug)
Azacitidine combined with Venetoclax
Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission.
Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to 36 months
ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator.
次要结局
- Duration of Remission (DOR)(Up to 36 months)
- Allogeneic Hematopoietic Stem Cell Transplantation Rate(Up to 36 months)
- Minimal residual disease (MRD) negative response rate(Up to 36 months)
- Overall Survival (OS)(Up to 36 months)
- Event-Free Survival (EFS)(Up to 36 months)