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CAR-T细胞治疗临床试验
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注册号:

Registration number:

ChiCTR-OCC-15007008 

最近更新日期:

Date of Last Refreshed on:

2015-09-04 

注册时间:

Date of Registration:

2015-08-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

CAR-T细胞治疗临床试验 

Public title:

A clinical trial of CAR-T cell therapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CAR-T细胞疗法治疗复发难治性CD19阳性急性白血病临床研究 

Scientific title:

A clinical trial of CAR-T cell therapy for relapsed and refractory CD19+ acute 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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun 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:

浙江大学医学院附属第一医院 

Applicant's institution:

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:

(2015)伦审(医疗)第7号 

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:

浙江大学医学院附属第一医院医疗伦理委员会 

Name of the ethic committee:

Medical 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:

2015-06-03 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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骨髓移植中心 

Primary sponsor:

Bone marrow transplantation center,first affiliated hospital of Zhejiang University,school of medicine 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun 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

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

first affiliated hospital of Zhejiang University, School of medicinel

Address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

the National Natural Science Foundation of China 

研究疾病:

白血病 

Target disease:

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评估CD19-CAR-T治疗方案的安全性,有效性和可行性 

Objectives of Study:

to evaluate the security, effectiveness and feasibility of CD9-CAR-T 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:

单臂 

Study design:

Single arm 

纳入标准:

1)符合以下条件的CD19阳性的急性白血病患者: A.CD19阳性ALL伴有复发难治、耐药病例。 B.移植前肿瘤负荷高,不能直接移植,可以通过CAR-T减低负荷,为移植做准备。 C.移植后复发,DLI无效,可采用受者体内的供者细胞,或者直接采集供者细胞,制备CAR-T防治复发,诱导再缓解。 D.反复MRD(+)难治耐药病例。 E.髓外白血病病灶(CNSL、胸腔、腹腔、骨骼等),放化疗难以根治。 2)年龄<60岁; 3)预计生存期大于6个月; 5)育龄妇女在给药开始前尿妊娠试验阴性,并同意在试验期间直至最后一次随访采取有效的避孕措施者; 6)自愿参加本实验并签署知情同意书者。 

Inclusion criteria

1. CD19 positive acute leukemia: (1) cases of CD19 positive ALL/lymphoma with relaps, refractoriness or durg risistence; (2) high tumor load before aHSCT; (3) failed DLI for relapse after aHSCT; (4) relapsed refractory MRD positive cases; (5) extramedullary leukemia failed for chemotherapy/radiotherapy; 2. aged 0-60; 3. expected survival beyond 6 months; 4. urine pregnancy test negative for fertile women,and agree to take contraception during the trial; 5. voluntarily anticipated the trial and sign the informed consent. 

排除标准:

具备下述排除标准中任何一项的患者不能入选本试验: 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)怀孕或哺乳期妇女(本疗法对未出生的孩子的安全性尚未知); 5)未治愈的有活动性感染者: 6)活动性乙型肝炎或丙型肝炎病毒感染者; 7)参加治疗前2周内合并使用全身性类固醇药物者(最近或目前正在使用吸入类固醇的除外); 8)之前使用过任何基因治疗产品者; 9)T细胞被复制缺陷型慢病毒转导的效率低于30%,或应答CD3 / CD28共刺激信号时扩增能力不足(<5倍)者; 10)肌酸酐>2.5mg/dl或ALT / AST>3倍正常量或胆红素>2.0 mg/dl者; 11)患有其他未被控制的疾病,研究者认为不适合加入者; 12)艾滋病病毒感染者; 13)研究者认为可能增加受试者危险性或干扰试验结果的任何情况。 

Exclusion criteria:

1. medical history of epilepsy or other disease of central nervous system; 2. case of GVHD using immunosuppressant; 3. medical history of prolonged QT period or other severe heart disease; 4. pregnancy or lactation; 5. uncured active infection; 6. active HBV/HCV infected; 7. steroid drug users in 2 weeks; 8. gene therapy product ever used; 9. transfection efficiency lower than 30%, or low amplification (<5 fold value); 10. serum creatinine>2.5mg/dl or ALT/AST>3 fold standard value or bilirubin>2.0 mg/dl; 11. any uncured disease considered unavailable for the trial; 12. HIV infected; 13. any condition may increase volunteer's risk or interference the outcome of the trial. 

研究实施时间:

Study execute time:

From2015-06-01To 2015-12-31 

干预措施:

Interventions:

组别:

CAR-T组

样本量:

10

Group:

CAR-T group

Sample size:

干预措施:

CAR-T细胞治疗

干预措施代码:

Intervention:

CAR-T 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 

Institution
hospital:

first affiliated hospital of Zhejiang University,school of medicinel  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

微小残留白血病

指标类型:

主要指标 

Outcome:

minimal residual diseas

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

原始细胞

指标类型:

主要指标 

Outcome:

remission 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:

骨髓

组织:

Sample Name:

Bone Marrow

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 0 years
最大 Max age 60 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):

no

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

no

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:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-08-24
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