The Efficacy and Safety of Azacytidine Combined With HAG Regimen Versus Azacytidine for Elderly Patients With Newly Diagnosed Myeloid Malignancy: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
研究概览
简要总结
The primary objective is to explore the efficacy and safety of azacytidine and HAG regimen versus azacytidine for elderly patients with Newly Diagnosed MDS/AML/CMML in China. This is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with MDS/AML/CMML in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given azacytidine + HAG regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60;
- •Patients with newly diagnoised diseases including MDS/AML/CMML;
- •The ECOG behavior status score is less than 3 points;
- •Agree to sign informed consent
排除标准
- •Patients with a history of sever heart disease;
- •Patients with severe organ dysfunction;
- •Patients with other malignancies
- •Patients who are allergic to the treatment of drug ingredients
研究组 & 干预措施
Azacytidine
75mg/m2
干预措施: Azacytidine (Drug)
Azacytidine + HAG Regimen
Azacytidine（75mg/m2 ）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) , Cytarabine 10mg/(m2.d), G-CSF 200ug/(m2.d) )
干预措施: Azacytidine, HAG Regimen (Drug)
结局指标
主要结局
Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Fourth Cycle Treatments.
时间窗: 4 months
次要结局
未报告次要终点