Decitabine in Combination With Chidamide, Homoharringtonine and Ara-c (DCHA) as Postremission Therapy for Acute Myeloid Leukemia With t(8;21) :A Multicenter Prospective Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy. Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with （tyrosine kinase）KIT mutation. So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.
详细描述
Treatment regimen
HA:
homoharringtonine 2mg IV d1-5 cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h
DCHA:
Decitabine 20mg/m2 d8-12 Chidamide 30mg twice/week P.O. for two weeks per cycle (four doses totally) cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h d1,3,5 homoharringtonine 2mg IV d10-14
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Written informed consent provided.
- •The patients were diagnosed AML-M2 with t(8;21) (q22;q22) chromosomal changes and positive acute myeloid leukemia(AML1)-eight twenty one(ETO) fusion gene according to the 2008 World Health Organization (WHO) diagnostic criteria for malignant myeloid diseases.
- •Males or females aged ≥18 years, < 65 years.
- •Eastern Cooperative Oncology Group（ECOG） performance status 0-
- •Life expectancy ≥3 months.
- •The morphology was Complete remission (CR) or Cri after 2 cycles of anthracycline induced chemotherapy.
- •No serious disease with heart, lung, liver and kidney.
- •The ability to understand and be willing to sign the Informed Consent Form of the experiment.
- •Patient who can start the investigational therapy within 3-6 weeks after the complete resection
- •Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- •Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- •Female subjects should not be pregnant or breast-feeding.
排除标准
- •Known allergic to prior treatment with drugs contained by the trial programme or with a chemical structure similar medicine.
- •Pregnancy, breast-feeding women and childbearing age patients who do not want to take contraceptive measures.
- •Active serious infection.
- •Patients with extramedullary lesions.
- •Patients who use drugs or drink alcohol for a long time to influence the evaluation of results.
- •Patients with mental illness or other conditions are unable to obtain knowledge and consent, and can not cooperate with the requirements of the completion of the test treatment and examination steps.
- •Patients with a history of the clinical significance of Q and T interval（QTc） prolongation (male > 450ms, female >470ms), ventricular tachycardia (VT), atrial fibrillation (AF), degree of heart block, muscle infarction (MI) within 1 years, congestive heart failure (CHF), with symptoms and drug therapy in patients with coronary heart disease.
- •Patients with abnormal liver function (total bilirubin > 1.5 x ULN, ALT/AST > 2.5 x ULN, or liver invasion ALT/AST > 5x ULN ), renal function abnormality (serum creatinine > 1.5 x ULN).
- •The researchers decided that patient was not appropriate to take part in the experiment.
研究组 & 干预措施
t(8;21)AML
chemotherapy 5-Aza-2'-deoxycytidine IV 20mg/m2 d8-12 homoharringtonine IV 2mg d1-5 chidamide P.O. 30mg twice/W cytarabine IV 1000mg/m2(<60 year old) 500mg/m2(>60 year old) IV q12h d1,3,5
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years
To evaluate the disease progression free survival of DCHA as postremission therapy for acute myeloid leukemia with t(8;21) . Progression free survival (PFS)- defined as the time from remission for the first time to the first documented disease progression.
次要结局
- Overall survival(2 years)
研究者
Li Yu
MD. PH.D
Chinese PLA General Hospital