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复方黄黛片联合地西他滨/CAG(HAG)方案治疗高风险MDS的多中心临床研究
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注册号:

Registration number:

ChiCTR1900027826 

最近更新日期:

Date of Last Refreshed on:

2019-11-30 

注册时间:

Date of Registration:

2019-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

复方黄黛片联合地西他滨/CAG(HAG)方案治疗高风险MDS的多中心临床研究 

Public title:

A multicenter clinical study for compound Huangdai tablet combined with Decitabine / CAG (HAG) regimen in the treatment of high risk MDS 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中西医结合治疗高风险MDS的多中心临床研究 

Scientific title:

Multicenter clinical study for integrated traditional Chinese and Western medicine in the treatment of high risk MDS 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

ChiMCTR1900025381 

申请注册联系人:

沈英英 

研究负责人:

林圣云 

Applicant:

Shen Yingying 

Study leader:

Lin Shengyun 

申请注册联系人电话:

Applicant telephone:

+86 18072946912 

研究负责人电话:

Study leader's telephone:

+86 13588887285 

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:

413808426@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

lsyww2003@163.com 

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:

浙江省杭州市上城区邮电路54号 

研究负责人通讯地址:

浙江省杭州市上城区邮电路54号 

Applicant address:

54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China 

Study leader's address:

54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China 

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:

浙江省中医院 

Applicant's institution:

Zhejiang Provincial Hospital of traditional Chinese medicine 

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:

2019-KL-016-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

浙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

First Hospital Ethics Committee, Zhejiang Chinese Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

夏冰 

Contact Name of the ethic committee:

XiaBing 

伦理委员会联系地址:

浙江省杭州市上城区邮电路54号 

Contact Address of the ethic committee:

54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

浙江中医药大学附属第一医院 

Primary sponsor:

The First affiliated Hospital of Zhejiang Chinese Medical University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区邮电路54号 

Primary sponsor's address:

54 Youdian Road, Shangcheng District, Hangzhou, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江中医药大学附属第一医院

具体地址:

浙江省杭州市上城区邮电路54号

Institution
hospital:

The First affiliated Hospital of Zhejiang Chinese Medical University

Address:

54 Youdian Road, Shangcheng District, Hangzhou

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

骨髓增生异常综合征 

Target disease:

MDS 

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:

探索性研究/预试验 

Study phase:

研究目的:

比较复方黄黛片联合地西他滨/CAG(HAG)方案治疗高风险MDS患者完全缓解率、长期生存率和副作用 

Objectives of Study:

to compare the complete remission rate, long-term survival rate and side effects of compound Huangdai tablet combined with Decitabine / CAG(HAG) regimen in high risk patients with MDS 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1)获得患者或其家属签署的知情同意书 2)经WHO诊断分型,IPSS-R预后评分确诊中高危MDS患者 3)年龄18-75岁 4)入选时体力评分(ECOG 评分)为 0-3 分 5)肝、肾功能:血胆红素≤2mg/dL(35 μmol/L),AST/ALT在正常值上限2倍以下, 血肌酐≤177μmol/L 6)心功能尚可:EF>50% 7)预计患者生存期≥3月 

Inclusion criteria

1) informed consent was obtained from the patient or his family; 2) according to WHO classification, IPSS-R prognosis was confirmed in high-risk MDS patients; 3) aged between 18 to 75 years; 4) Physical Strength Score (ECOG score 0-3; 5) liver and renal function: Bilirubin <=2 mg/dL 35 mol/L, AST/ALT less than 2 times the upper limit of the normal value, creatinine <=177 mol/l; 6) Cardiac function was acceptable: EF >50%; 7) predicted survival >=3 months. 

排除标准:

1)ECOG 评分在4分以上 2)血清胆红素>2mg/dL(35 μmol/L);ALT或AST >2倍正常值上限;碱性磷酸酶>3 倍正常值上限;血清肌酐>177 μmol/L 3)HIV等传染病检测结果阳性 4)其他严重的可能限制患者参加此试验的疾病(例如进展期感染、不能控制的糖尿病、严重的心功能不全或心绞痛等) 5)怀孕或哺乳期妇女或伴有全身情况不佳不适合化疗的人员 6)不能理解或遵从研究方案的人员 

Exclusion criteria:

1) ECOG score>4; 2) serum Bilirubin > 2 Mgdl 35 Mol/L; ALT or AST > 2 x Upper limit of normal; Alkaline phosphatase > 3 ULN; Serum Creatinine > 177 Mol/L; 3) HIV test positive; 4) other serious diseases that may limit patients from participating in the trial (e.g. progressive infection, uncontrolled diabetes, severe cardiac insufficiency or Angina); 5) pregnant or lactating women or persons with General Conditions Not Suitable for chemotherapy; 6) who do not understand or follow the protocol. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

地西他滨联合HAG/CAG

干预措施代码:

Intervention:

Decitabine / CAG (HAG)

Intervention code:

组别:

治疗组

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

复方黄黛片+地西他滨联合HAG/CAG

干预措施代码:

Intervention:

compound Huangdai tablet combined with Decitabine / CAG (HAG)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江中医药大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First affiliated Hospital of Zhejiang Chinese Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省立同德医院 

单位级别:

三甲 

Institution
hospital:

Zhejiangprovincial Tongde Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Wenzhou Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

金华人民医院 

单位级别:

三甲 

Institution
hospital:

Jinhua People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

绍兴第二人民医院 

单位级别:

三乙 

Institution
hospital:

Shaoxing Second People's Hospital  

Level of the institution:

Tertiary B Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

绍兴人民医院 

单位级别:

三甲 

Institution
hospital:

Shaoxing People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

完全缓解率

指标类型:

主要指标 

Outcome:

CR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3年无事件生存率

指标类型:

主要指标 

Outcome:

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:

3年的总生存率

指标类型:

主要指标 

Outcome:

OS

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:

标本中文名:

骨髓

组织:

Sample Name:

Bone Marrow

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

外周血

组织:

Sample Name:

Peripheral blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 75 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):

非随机

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

None randomization

盲法:

No

Blinding:

No

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

http://218.75.123.194/portal/root/lsy_rnaseq/index.jsp

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

http://218.75.123.194/portal/root/lsy_rnaseq/index.jsp

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

一为病例记录表,二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

First Case Record Form, CRF),Electronic Data Capture.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-30
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