A Single-center, Single-arm, Prospective Clinical Study on the Efficacy and Safety of Venetoclax and Azacitidine Combined With HAAG in the Induction Treatment of Intermediate and High-risk Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Composite complete response rate (CRc; CR+CRi)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.
详细描述
This is a single-center, single-arm, prospective clinical study in newly diagnosed intermediate and high-risk AML patients. The patients will receive venetoclax, azacitidine combined with HAAG regimen in the induction treatment.
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
- •Newly diagnosed intermediate and high-risk AML according to the WHO (2022) classification of acute myeloid leukemia (non-APL).
- •ECOG score: 0-
- •No history of previous chemotherapy or target therapy.
- •Serum total bilirubin <= 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) <= 1.5 times ULN, aspartate aminotransferase (AST) <=1.5 times ULN;
- •Creatinine clearance rate >=30 mL/min;
- •Serum lipase <= 1.5 times ULN, amylase <= 1.5 times ULN;
- •Capable to understand and willing to participate in this study, signed the informed consent form.
排除标准
- •AML transformed with chronic myelogenous leukemia.
- •Acute promyelocytic leukemia (type M3).
- •Patients with a second malignancy requiring treatment.
- •Patients with uncontrolled active infection.
- •Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- •Patients with hepatic and renal inadequacy: total serum bilirubin >=2.0 mg/dl, AST >=3 times ULN, serum creatinine clearance (Ccr) <50 ml / min.
- •Patients with arterial oxygen saturation (SpO 2) was <95%.
- •Patients with HIV infection.
- •Patients with active hepatitis B or hepatitis C infection.
- •Patients with other commodities that the investigators considered not suitable for the enrollment.
研究组 & 干预措施
VA combined with HAAG
This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.
干预措施: venetoclax, azacitidine and HAAG regimen (Drug)
结局指标
主要结局
Composite complete response rate (CRc; CR+CRi)
时间窗: Day 28-35 of induction course
CRc includes complete response CR and CRi; CR was defined as \< 5% bone marrow blasts in an aspirate with spicules, no blasts with Auer rods or persistence of extramedullary disease, and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia.
次要结局
- Partial remission (PR)(Day 28-35 of induction course)
- Relapse-free survival (RFS)(3 years)
- Number of adverse events(2 years)
- Overall survival (OS)(3 years)