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靶向CD19 CAR-T细胞治疗复发难治B淋巴细胞白血病/淋巴瘤的实验性临床研究

  • 发布时间:2018-02-02
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靶向CD19 CAR-T细胞治疗复发难治B淋巴细胞白血病/淋巴瘤的实验性临床研究...

注册号:

Registration number:

ChiCTR1800014248 

最近更新日期:

Date of Last Refreshed on:

2018-01-02 

注册时间:

Date of Registration:

2018-01-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

靶向CD19 CAR-T细胞治疗复发难治B淋巴细胞白血病/淋巴瘤的实验性临床研究 

Public title:

Experimental and clinical research of targeted CD19 CAR - T cells treatment for refractory or recurrence B lymphocyte leukemia/lymphoma 

注册题目简写:

 

English Acronym:

ECRTCCTCTRRBLL 

研究课题的正式科学名称:

靶向CD19 CAR-T细胞治疗复发难治B淋巴细胞白血病/淋巴瘤的实验性临床研究 

Scientific title:

Experimental and clinical research of targeted CD19 CAR - T cells treatment for refractory or recurrence B lymphocyte leukemia/lymphoma 

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:

郑润辉 

研究负责人:

谭获 

Applicant:

ZHENG RUNHUI 

Study leader:

TAN HUO 

申请注册联系人电话:

Applicant telephone:

+86 13828455028 

研究负责人电话:

Study leader's telephone:

+86 02034293776 

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:

jackeny@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tanhuo.2008@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:

广州海珠区康大路1号11楼血液内科办公室 

研究负责人通讯地址:

广州海珠区康大路1号11楼血液内科办公室 

Applicant address:

1 Kangda Road, Haizhu District, Guangzhou, Guangdong, China 

Study leader's address:

1 Kangda Road, Haizhu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510230 

研究负责人邮政编码:

Study leader's postcode:

510230 

申请人所在单位:

广州医科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Guangzhou Medical 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:

2017-85 

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:

广州医科大学附属第一医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of The First Affiliated Hospital of Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-27 

伦理委员会联系人:

余达加 

Contact Name of the ethic committee:

YU DAJIA 

伦理委员会联系地址:

广州越秀区沿江西路151号 

Contact Address of the ethic committee:

151 Yanjiangxi road, Yuexiu district, Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-83062938 

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:

广州医科大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Guangzhou Medical University 

研究实施负责(组长)单位地址:

广州医科大学附属第一医院 

Primary sponsor's address:

151 Yanjiangxi road, Yuexiu district, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州医科大学附属第一医院

具体地址:

广州越秀区沿江西路151号

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University

Address:

151 Yanjiangxi road, Yuexiu district, Guangzhou, Guangdong, China

经费或物资来源:

武汉金益肽生物有限公司 

Source(s) of funding:

Wuhan jinyi peptide biology co. LTD 

研究疾病:

急慢性B淋巴细胞白血病、淋巴瘤 

Target disease:

B cell leukemia/lymphoma 

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)评估CD19CART细胞治疗复发/难治CD19阳性淋巴瘤/白血病的有效性; 2)评估CD19CART细胞治疗的安全性。  

Objectives of Study:

1) evaluate the effectiveness of CD19CART cell therapy for recurrence/refractory CD19 positive lymphoma/leukemia; 2) evaluate the safety of CD19CART cell therapy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

1, 疾病诊断:1). 复发难治B细胞淋巴瘤(CD19阳性);2). 复发难治慢性淋巴细胞白血病(CD19阳性)。3)复发难治急性B淋巴细胞白血病(CD19阳性) 2,年龄:16-80周岁; 3,预测生存期>12周; 4,患者无心肝肾功能不全; 5,患者可进行外周血抽取,且分离出来的外周血单个核细胞(PBMCs)能被CD3 /CD28抗体激活并能在体外很好地扩增; 6,患者如接受过同种异体造血干细胞移植,需在6个月的恢复期之后;无明显移植物抗宿主疾病发生,以及依赖免疫抑制剂治疗; 7,患者无明显CD19阳性B-ALL导致的中枢神经系统症状(如脑膜白血病); 8,无不可控制的活动期感染,无活动期HBV,HCV及HIV感染; 9,患者若为生殖期女性,需排除怀孕可能,且在治疗期间有效避孕; 10,三个月内未全身使用过类固醇类药物(如激素)治疗; 11,未接受过任何其他基因治疗药物和制剂。 

Inclusion criteria

1. disease diagnosis: (1) Recurrent refractory B cell lymphoma (CD19 positive); (2) Recurrent refractory chronic lymphocytic leukemia (CD19 positive); (3) recurrent refractory acute B lymphocytic leukemia (CD19 positive). 2. Aged 16-80 years old; 3. Predict the survival period > 12 weeks; 4. Patients with unintentional liver and renal insufficiency; 5. Peripheral blood extraction can be performed and isolated peripheral blood cell (PBMCs) can be activated by CD3 /CD28 antibody and can be amplified in vitro; 6. Patients who have received allogeneic hematopoietic stem cell transplantation should be after the recovery period of 6 months. No obvious graft versus host disease, and dependence on immunosuppressive therapy; 7. Patients with no significant CD19 positive b-all caused central nervous system symptoms (such as meningeal leukemia); 8. No uncontrollable activity period infection, no active period HBV, HCV and HIV infection; 9. If a patient is a woman of reproductive period, she should be excluded from pregnancy and effective contraception during treatment; 10. Untreated steroids (such as hormone) were not used in three months; 11. No other gene therapy drugs or agents have been received. 

排除标准:

1,预测生存期<12周; 2,患者心肝肾功能不全; 3,明显CD19阳性B-ALL导致的中枢神经系统症状(如脑膜白血病); 4,活动期感染,HBV,HCV及HIV感染; 5,接受过任何其他基因治疗药物和制剂。 

Exclusion criteria:

1. Prediction of survival <12 weeks; 2. Patients with cardiac renal insufficiency; 3. The symptoms of central nervous system (such as meningeal leukemia) caused by the obvious CD19 positive b-all. 4. Active stage infection, HBV, HCV and HIV infection; 5. Have received any other gene therapy drugs and preparations. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

30

Group:

Case series

Sample size:

干预措施:

CART治疗

干预措施代码:

 

Intervention:

therapy by CART

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of GuangZhou Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

缓解率

指标类型:

主要指标 

Outcome:

Response 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:

 

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 16  years
最大 Max age 80  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):

单臂试验

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

One-armed test

盲法:

 

Blinding:

 

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):

2020-6-1公开数据

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

2020-6-1 public data

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表

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

CRF form

数据管理委员会:

Data Managemen Committee:

有/Yes