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Clinical and basic research on BCMA-CAR T cells in the treatment of multiple myeloma
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注册号:

Registration number:

ChiCTR1800017404 

最近更新日期:

Date of Last Refreshed on:

2018-07-28 

注册时间:

Date of Registration:

2018-07-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

BCMA-CAR T 细胞治疗多发性骨髓瘤的临床与基础研究 

Public title:

Clinical and basic research on BCMA-CAR T cells in the treatment of multiple myeloma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

BCMA-CAR T 细胞治疗多发性骨髓瘤的临床与基础研究 

Scientific title:

Clinical and basic research on BCMA-CAR T cells in the treatment of multiple myeloma 

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:

Hu Yongxian 

Study leader:

Huang He 

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:

hehuangyu@126.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 

Applicant's institution:

the First Affiliated Hospital of Zhejiang University School of 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:

747-8 

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科研伦理审查委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-13 

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:

浙江省杭州市庆春路79号 

Contact Address of the ethic committee:

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 of Zhejiang University School of Medicine 

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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市庆春路79号

Institution
hospital:

the First Affiliated Hospital of Zhejiang University School of Medicine

Address:

79 Qingchun Road, Hangzhou, Zhejiang, China

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:

多发性骨髓瘤 

Target disease:

Multiple Myeloma 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1,观察BCMA-CART治疗多发性骨髓瘤的缓解率(CR、PR)和总生存期(OS)、无病生存期(EFS)。 2,评估BCMA-CART治疗多发性骨髓瘤的安全性、CRS 发生率、中枢神经系统毒性发生率、复发率。 3,观察CART病人治疗前后的粪便菌群变化。 

Objectives of Study:

The remission rate (CR and PR), total survival(OS) and disease- free survival( EFS) of BCMA-CART in the treatment of multiple myeloma were observed.The safety, CRS rate, relapse rate and Neurotoxicity rate were evaluated of BCMA-CART in the treatment of multiple myeloma.Changes in fecal flora before and after treatment in patients with CART. 

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)BCMA阳性恶性血液病伴有复发难治、耐药病例。 2)预期生存>12周; 3)育龄妇女在给药开始前尿妊娠试验阴性; 4)自愿参加本试验并签署知情同意书。  

Inclusion criteria

1. Relasped or refractory hematological malignancies with BCMA positive; 2. Expected life time is more than 12 weeks; 3. urine pregnancy test negative; 4. Voluntarily participate in the trial and sign the informed consent form.  

排除标准:

1)具有癫痫病史或其他中枢神经系统疾病者; 2)具有移植物抗宿主反应,需要使用免疫抑制剂者; 3)既往有QT期间延长或严重心脏疾病者;: 4)活动性乙型肝炎或丙型肝炎病毒感染者; 5)艾滋病病毒感染者;  

Exclusion criteria:

1. patients with the history of epilepsy or other CNS disease; 2. patiets with GVHD who need immunosuppressive agents; 3. Patients with prolonged QT interval time or severe heart disease; 4. Patients with active hepatitis B or C infection; 5. patients with HIV infection.  

研究实施时间:

Study execute time:

From2018-07-31To 2023-07-31 

干预措施:

Interventions:

组别:

Case series

样本量:

100

Group:

Case series

Sample size:

干预措施:

BCMA-CART治疗

干预措施代码:

Intervention:

BCMA-CART therapy

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):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

the First Affiliated Hospital of Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

CART治疗反应率

指标类型:

主要指标 

Outcome:

the response of CART

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

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:

无病生存期

指标类型:

主要指标 

Outcome:

disease-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:

复发率

指标类型:

主要指标 

Outcome:

recurrence rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRS 发生率

指标类型:

主要指标 

Outcome:

CRS rate

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:

血液

组织:

Sample Name:

blood

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:

粪便

组织:

Sample Name:

fecal

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

N/A

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 ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

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

no

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:

有/Yes

注册人:

Name of Registration:

 2018-07-28
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