Single Arm,Open Label,Phase I Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.
详细描述
Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are able to understand and willing to sign the informed consent form (ICF).
- •All patients should aged 14 to75 years,no gender limitation.
- •Patients who are newly diagnosed with AML.
- •Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
- •Renal function: creatinine ≤the upper limit of normal;
- •Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
- •The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
- •Patients without severe allergic constitution.
排除标准
- •Patients with allergy or contraindication to the study drug;
- •Female patients who are pregnant or breast-feeding.
- •Patients with active infection
- •Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
- •Patients with mental illness or other states unable to comply with the protocol;
- •Less than 6 weeks after surgical operation of important organs.
- •Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin>2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
- •The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
研究组 & 干预措施
treatment group
Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.
干预措施: azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 month after study treatment
Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).
次要结局
- Rate of Minimal Residual Disease (MRD)-Negative Response:(after two courses of chemotherapy (each course is 28 days))
- Progression Free Survival (PFS)(180 days after study treatment)
- Overall Survival (OS)(180 days after study treatment)
- Rate of Participants With Adverse Events(Through 28 days post last study medication administration)
- Partial Remission (PR) Rate:(1 month after study treatment)
- Complete Remission (CR) Rate(1 month after study treatment)
- CR with Incomplete Blood Count Recovery Rate(1 month after study treatment)
研究者
Daihong Liu
doctor
Chinese PLA General Hospital