Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
The purpose of this study is to compare the efficacy of CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming) to decitabine in the treatment of higher-risk myelodysplastic syndromes(MDS).
详细描述
Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2 years as well as a high risk of their disease progressing to acute myeloid leukemia (AML). The only treatment with a curative potential is allogeneic stem cell transplantation. However, in the majority of patients, this treatment is not applicable, mainly due to the age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine (decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases, irreversibly inhibiting their function, leading to the progressive loss of methylation and reversal of gene silencing. The purpose of this study is to compare the efficacy and safety of CHG regimen to Decitabine in higher-risk MDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age rang from 16 to 80 years;
- •diagnosis of higher-risk MDS (with≥ 5% blast in bone marrow);
- •a performance status of 0-3 according to the Eastern Cooperative Oncology Group (ECOG);
- •no evidence of severe concurrent cardiac, pulmonary, neurologic, or metabolic diseases;
- •adequate hepatic (serum bilirubin level <2×upper normal limit) and renal (serum creatinine <2×upper normal limit) function tests.
排除标准
- •Female with pregnancy;
- •a performance of 4-5 according to ECOG score;
- •HIV positive;
- •uncontrolled severe fungal infection or tuberculosis;
- •with other progressive malignant diseases.
研究组 & 干预措施
CHG regimen
one course of CHG regimen (low-dose cytarabine, homoharringtonine and G-CSF priming)
干预措施: CHG regimen (Drug)
Decitabine
one course of Decitabine (5-aza-deoxycytidine,Dacogen)
干预措施: 5-aza-deoxycytidine (Drug)
结局指标
主要结局
complete remission rate
时间窗: four weeks after one course of CHG or two courses of Decitabine
次要结局
- non-hematologic toxicities(within the first 4 weeks after CHG or Decitabine)
- overall survival(two years)
- overall remission rate(four weeks after one course of CHG or two courses of Decitabine)
- disease free survival(two years)
- hematology toxicities(within the first 4 weeks after CHG or Decitabine regimen)
研究者
Xiao Li
Doctor
Shanghai 6th People's Hospital