Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- Composite complete remission (CRc)
研究概览
简要总结
To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
详细描述
Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);
- •Age ≥18 years old;
- •The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.
排除标准
- •Known history of allergy to the investigational drug;
- •Resistance to azacytidine, azacitidine, Venetoclax;
- •Inability to take oral medication;
- •Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
- •Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
- •Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
研究组 & 干预措施
ABC-14 regimen
AZA,Venetoclax,Chidamide
干预措施: Chidamide (Drug)
ABC-14 regimen
AZA,Venetoclax,Chidamide
干预措施: Venetoclax (Drug)
ABC-14 regimen
AZA,Venetoclax,Chidamide
干预措施: azacitidine (Drug)
3+7 chemotherapy regimen
Daunorubicin/idarubicin/mitoxantrone and cytarabine
干预措施: Anthracyclines or anthraquinones (Drug)
3+7 chemotherapy regimen
Daunorubicin/idarubicin/mitoxantrone and cytarabine
干预措施: cytarabine (Drug)
AB-14 regimen
AZA,Venetoclax
干预措施: Venetoclax (Drug)
AB-14 regimen
AZA,Venetoclax
干预措施: azacitidine (Drug)
结局指标
主要结局
Composite complete remission (CRc)
时间窗: 2 months
composite complete remission，CRc: CR + CRi + MLFS
次要结局
- RFS(1 year)
- DoR(2 year)
- the rate of MRD turn negative(6 months)
- OS(1 year)
- AE(Throughout the study until the end, up to 2 years)