A Multi-center Prospective Single Arm Clinical Study of Reduced Intensive 3 + 5 Idarubicin and Cytarabine Chemotherapy Plus Venetoclax as First-line Treatment for Adults With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- CR
研究概览
简要总结
Reduced intensive 3 + 5 idarubicin and cytarabine chemotherapy plus venetoclax as first-line treatment for adults with acute myeloid leukaemia and high-risk myelodysplastic syndrome
详细描述
Multiple clinical trials about chemotherapy plus venetoclax in primary diagnosed AML or relapsed/refractly AML were ongoing to attempt the facility of the combination. Zu et al demostrated that full dose of 3 + 7 daunorubicin and cytarabine chemotherapy plus 8 days escalated venetoclax acheived 91% of CR/CRi with 97% 1-year overall survival and 72% 1-year event-free survival. In this trial , we try to reduced the intensive of 3 + 5 idarubicin and cytarabine chemotherapy, but prolong venetoclax to two weeks in the induction therapy in adults AML/MDS. We expect to increase the induced remission rate by extending the dosage of targeted drug venetoclax, and minimize the side effects by reducing the dose of 3 + 7 induction chemotherapy, so as to achieve the goal of high efficiency and low toxicity.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-60 years
- •had a confirmed diagnosis of previously untreated de novo acute myeloid leukaemia or high risk myelodysplastic syndrome by bone marrow examination according to the criteria presented by WHO.
- •Eastern Cooperative Oncology Group performance status of 0-
- •adequate renal and hepatic function (appendix 2 p 45), and left ventricular ejection fraction of at least 45% by echocardiography.
排除标准
- •younger than 18 years old, or older than 60 years old.
- •Diagnosed as acute promyelocytic leukaemia.
- •Pretreated with anthracycline.
- •CNS involvement.
- •Positive for HIV, hepatitis B virus, or hepatitis C virus.
- •New York Heart Association cardiovascular disability status higher than grade 2 (grade 2 is defined as cardiac disorder that is asymptomatic at rest, but ordinary physical activity might result in fatigue, palpitations, dyspnoea, or angina), chronic respiratory diseases requiring continuous supplementary oxygen, inability to take oral medication or malabsorption syndrome
- •Uncontrollable systemic infection (viral, bacterial, or fungal),
- •Inability to sign the informed consent form.
研究组 & 干预措施
treatment group
Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy
干预措施: idarubicin (Drug)
treatment group
Reduced intensive of 3 + 5 Idarubicin and Cytarabine plus Venetoclax as induction therapy
干预措施: Cytarabine (Drug)
结局指标
主要结局
CR
时间窗: Week 6
assessment of the composite complete remission rate (CR=CR+CRi)
次要结局
- adverse events(at any time)
- MRD(Week 6)
- EFS(2 years)
- OS(2 years)
研究者
Weiyan Zheng
Clinical Professor
First Affiliated Hospital of Zhejiang University