The Multi-center Clinical Trials of Thalidomide in TI
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Effective Rate of Patients
研究概览
简要总结
This is an exploratory experiment, aims to explore the effective and safety of thalidomide in the treatment of TI to improve the hemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion,60~100 patients will be enrolled.
详细描述
The project is a single arm research of thalidomide in TI,patients volunteered to participate in this trial and met the following inclusion criteria will be enrolled: age from 18~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Subjects should take thalidomide 50mg per day. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions were closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were evaluated in screening-period visit,1-month visit, 3-months visit , 6-months visit ,9-months visit, 12-months visit and 15-months visit.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •Diagnosis of NTDT;
- •Ages 18-65 years;
- •ECOG: 0~2 scores;
- •If not blood transfusion,the level of HB<90g/dl, or blood transfusion to maintain the HB;
- •Sign an informed consent agreeing to the clinical trial participation.
排除标准
- •Patients presenting with any of the following criteria will not be included in the trial:
- •Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;
- •Women during Pregnancy, breastfeeding or those of childbearing age who do not want to take contraceptive measures;
- •Patients had comorbidities like severe heart or lung diseases, liver dysfunction, cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary diseases;
- •Patients Allergic to the drug ingredients;
- •Patients with any Mental problem;
- •Patients had Participated in other drug clinical trials in the past 1 month;
- •Patients had a history of venous or arterial thrombosis;
- •In certain circumstances that the researchers determined it was not suitable for the research.
研究组 & 干预措施
thalidomide thalassemia
thalidomide:50mg/d p.o
干预措施: Thalidomide (Drug)
结局指标
主要结局
The Effective Rate of Patients
时间窗: 24 months
All participants will complete the treatment for 24 months, the hemoglobin value will be observed during the treatment,the value increased more than 20g/L defined as the marked effect,increased to 10\~20g/L defined as effective, otherwise invalid.
次要结局
- The Marked Improvement Rate of Patients(24 months)
研究者
Xiao-Lin Yin
Director, NO.3 Hospital of the People's Liberation Army
303rd Hospital of the People's Liberation Army