ChiCTR-TRC-13004054 版本V1.1 版本创建时间2016/6/19 21:09:31 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR-TRC-13004054 

最近更新时间:

Date of Last Refreshed on:

2016/6/19 21:08:09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

比较口服四硫化四砷+维甲酸和静脉三氧化二砷+维甲酸治疗非高危急性早幼粒细胞白血病的有效性性的随机对照III期临床试验 

Public title:

A Randomized Phase III Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

比较口服四硫化四砷+维甲酸和静脉三氧化二砷+维甲酸治疗非高危急性早幼粒细胞白血病的有效性性的随机对照III期临床试验 

Scientific title:

A Randomized Phase 3 Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

主鸿鹄 

研究负责人:

黄晓军 

Applicant:

Hong-Hu Zhu 

Study leader:

Xiao-Jun Huang 

申请注册联系人电话:

Applicant telephone:

+86 13671232272 

研究负责人电话:

Study leader's telephone:

+86 13701389625 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

zhuhhdoc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xjhrm@medmail.com.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京西直门南大街11号 

研究负责人通讯地址:

北京西直门南大街11号 

Applicant address:

11 South Xizhimen Street, Beijing 

Study leader's address:

11 South Xizhimen Street, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

北京大学人民医院 

Applicant's institution:

Peking University People's Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2013-11 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

北京大学人民医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Peking University People’s Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-11-22 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

北京大学人民医院 

Primary sponsor:

Peking University People's Hospital Address 

研究实施负责(组长)单位地址:

北京西直门南大街11号 

Primary sponsor's address:

11 South Xizhimen Street, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学人民医院

具体地址:

北京西直门南大街11号

Institution
hospital:

Peking University People's Hospital Address

Address:

11 South Xizhimen Street, Beijing

经费或物资来源:

自筹 

Source(s) of funding:

No 

研究疾病:

急性早幼粒细胞白血病 

Target disease:

Acute Promyelocytic Leukemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

III期临床试验 

Study phase:

III (Phase III study) 

研究目的:

比较口服复方黄黛片+维甲酸和静脉亚砷酸+维甲酸治疗非高危急性早幼粒细胞白血病的有效性 

Objectives of Study:

To compare the efficacy of oral tetra-arsenic tetra-sulphide formula plus ATRA versus intravenous ATO plus ATRA for newly diagnosed, non high-risk acute promyelocytic leukemia. 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1.初诊APL病人(WHO 2008诊断分类) 2.年龄18-70岁 3.体力评分为0-2(WHO) 4.治疗前WBC ≤ 10 x 109/L 5.肝功能:ALT和AST≤2.5倍正常值高限,胆红素≤2倍正常值高限 6.血肌酐 ≤ 3.0 mg/dL (≤ 260 μmol/L); 7. 签署知情同意书 

Inclusion criteria

1. Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis; 2. To be aged 18 to 71 years; 3. WHO performance status 0-2 included;4.white blood cell at diagnosis <=10*10^9/L; 5. Serum total bilirubin <=3.0 mg/dL (<=51umol/L); 6. Serum creatinine <=3.0 mg/dL (<=260 umol/L); 7.Signed written informed consent. 

排除标准:

1. 伴有脑出血 2.妊娠 3.不签署知情同意书 4.严重的心律失常,ECG异常(QT>500ms)。 5.患有精神疾病或其他情况无法按方案进行 

Exclusion criteria:

1. cerebral ischemic; 2. pregnancy; 3. Subjects who cannot sign written informed consent; 4. Significant arrhythmias, EKG abnormalities or neuropathy; 5. Subjects who cannot comply with the study. 

研究实施时间:

Study execute time:

From2013-12-11To 2016-12-31 

干预措施:

Interventions:

组别:

1

样本量:

72

Group:

study group

Sample size:

干预措施:

Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA

干预措施代码:

Intervention:

Oral Tetra-arsenic Tetra-sulphide Formula Plus ATR

Intervention code:

组别:

2

样本量:

37

Group:

control group

Sample size:

干预措施:

EFS

干预措施代码:

Intervention:

EFS

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲 

Institution
hospital:

Peking University People’s Hospita  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲 

Institution
hospital:

Peking University First Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

徐州医学院 

单位级别:

三甲 

Institution
hospital:

the Affiliated Hospital of Xuzhou Medical College  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

苏州 

市(区县):

 

Country:

China 

Province:

Suzhou 

City:

 

单位(医院):

苏州大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

First Affiliated Hospital of Soochow University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨血液肿瘤研究所 

单位级别:

国家药理临床试验基地 

Institution
hospital:

Harbin Institute of Hematology and Oncology  

Level of the institution:

The national drug clinical research base 

测量指标:

Outcomes:

指标中文名:

Rate of Event-free survival (EFS)

指标类型:

主要指标 

Outcome:

Rate of Event-free survival (EFS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Rate of cumulative incidence of relaps

指标类型:

主要指标 

Outcome:

Rate of cumulative incidence of relaps

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Rate of hematological complete remission

指标类型:

次要指标 

Outcome:

Rate of hematological complete remission

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Overall survival rate

指标类型:

次要指标 

Outcome:

Overall survival rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by National Cancer Institute Common Toxicity Criteria

指标类型:

次要指标 

Outcome:

Incidence of hematological and non-hematological toxicity episodes during treatment as assessed by National Cancer Institute Common Toxicity Criteria

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Quality of life at the end of induction therapy and at the end of the consolidation course

指标类型:

次要指标 

Outcome:

Quality of life at the end of induction therapy and at the end of the consolidation course

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Rate of cumulative incidence of relapse

指标类型:

主要指标 

Outcome:

Rate of cumulative incidence of relapse

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由中央随机系统的计算机产生随机号

Randomization Procedure (please state who generates the random number sequence and by what method):

computer generated

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

Not stated

Data management Institution:

Not stated

资料分析单位:

Not stated

Data analysis Institution:

Not stated

注册人:

Name on Registration:

 2013-12-27