今天是:2019-09-17 星期二

CAR-T细胞联合半相合造血干细胞移植治疗难治复发急性淋巴细胞白血病
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注册号:

Registration number:

ChiCTR1900023957 

最近更新日期:

Date of Last Refreshed on:

2019-06-19 

注册时间:

Date of Registration:

2019-06-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

CAR-T细胞联合半相合造血干细胞移植治疗难治复发急性淋巴细胞白血病 

Public title:

CAR-T therapy followed by haploidentical HSCT have prominent therapeutic efficacy for patients with relapsed/refractory acute lymphoblastic leukemia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CAR-T细胞联合半相合造血干细胞移植治疗难治复发急性淋巴细胞白血病 

Scientific title:

CAR-T therapy followed by haploidentical HSCT have prominent therapeutic efficacy for patients with relapsed/refractory acute lymphoblastic leukemia 

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:

 

申请注册联系人:

胡永仙 

研究负责人:

黄河 

Applicant:

Yongxian Hu 

Study leader:

He Huang 

申请注册联系人电话:

Applicant telephone:

+86 15957162012 

研究负责人电话:

Study leader's telephone:

+86 13605714822 

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:

huyongxian2000@aliyun.com 

研究负责人电子邮件:

Study leader's E-mail:

huanghe@zju.edu.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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院骨髓移植中心 

Applicant's institution:

Bone Marrow Transplantation Center, the First Affiliated Hospital, School of Medicine, Zhejiang University 

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:

853 

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:

浙江大学医学院附属第一医院伦理委员会 

Name of the ethic committee:

Research ethics of the First Affiliated Hospital, School of Medicine,Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-24 

伦理委员会联系人:

殷琳 

Contact Name of the ethic committee:

Lin Yin 

伦理委员会联系地址:

浙江大学医学院附属第一医院 

Contact Address of the ethic committee:

the First Affiliated Hospital, School of Medicine, Zhejiang University, 79 Qingchun Road, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

the First Affiliated Hospital, School of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海儿童医院

具体地址:

上海市北京西路

Institution
hospital:

Shanghai Children's Medical Center

Address:

Beijing Road West, Shanghai

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省第二人民医院

具体地址:

广州市海珠区新港中路

Institution
hospital:

Guangdong Second Provincial General Hospital

Address:

Xinxiangzhong Road, Zhuhai District, Guangzhou

国家:

上海

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第一人民医院

具体地址:

上海市武进路85号

Institution
hospital:

Shanghai General Hospital

Address:

85 Wujin Road

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海同济医院

具体地址:

上海市新村路389号

Institution
hospital:

Shanghai Tongji Hospital

Address:

389 Xincun Road

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

Natural science foundation of China 

研究疾病:

难治复发急性淋巴细胞白血病 

Target disease:

refractory/relapsed acute lymphoblastic leukemia 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

评估CAR-T细胞治疗联合半相合造血干细胞移植治疗难治复发急性淋巴细胞白血病的安全性及有效性研究 

Objectives of Study:

To evaluate the safety and efficacy of CAR-T therapy followed by haplo-HSCT for relapsed/refractory acute lymphocytic leukemia 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.难治复发急性淋巴细胞白血病 2.接受CAR-T联合半相合造血干细胞移植治疗 3.年龄小于70岁 

Inclusion criteria

1. refractory/relapsed acute lymphoblastic leukemia; 2. received CAR-T followed by haplo-HSCT; 3. younger than 70 years old. 

排除标准:

1.合并重要脏器功能不全者 2.合并重症感染 3.合并传染性疾病 

Exclusion criteria:

1. complicated with organs dysfunction; 2. complicated with severe infection; 3. complicated with infectious disease. 

研究实施时间:

Study execute time:

From2015-07-01To 2019-06-06 

干预措施:

Interventions:

组别:

Case series

样本量:

31

Group:

Case series

Sample size:

干预措施:

CAR-T联合半相合造血干细胞移植

干预措施代码:

Intervention:

CAR-T followed by haploHSCT

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三甲 

Institution
hospital:

the First Affiliated Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海儿童医学中心 

单位级别:

三甲 

Institution
hospital:

Shanghai Children's Medical Center  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省第二人民医院 

单位级别:

三甲 

Institution
hospital:

Guangdong Second Provincial General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海同济医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Tongji Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总体生存

指标类型:

主要指标 

Outcome:

Overall survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无病生存

指标类型:

主要指标 

Outcome:

leukemia free survival

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急性移植物抗宿主病

指标类型:

次要指标 

Outcome:

acute graft versus host disease

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

感染率

指标类型:

次要指标 

Outcome:

infection rate

Type:

Secondary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 65 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):

N/A

盲法:

N/A

Blinding:

N/A

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020年1月,网络录入ResMan

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

web,January/2020; ResMan

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-06-19
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