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CD19+-CAR-T细胞联合化疗治疗新诊断的高危成人PH(-)-B-ALL的多中心临床研究

  • 发布时间:2018-03-25
  • 浏 览:229次

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注册号:

Registration number:

ChiCTR1800015164 

最近更新日期:

Date of Last Refreshed on:

2018-03-11 

注册时间:

Date of Registration:

2018-03-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

CD19+-CAR-T细胞联合化疗治疗新诊断的高危成人PH(-)-B-ALL的多中心临床研究 

Public title:

multi-center clinical study of CD19+ -car-t cells combined with chemotherapy in the treatment of the newly diagnosed high-risk adult PH (-) B-ALL 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CD19+-CAR-T细胞联合化疗治疗新诊断的高危成人PH(-)-B-ALL的多中心临床研究 

Scientific title:

multi-center clinical study of CD19+ -car-t cells combined with chemotherapy in the treatment of the newly diagnosed high-risk adult PH (-) B-ALL 

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:

隋涛 

研究负责人:

赵明峰 

Applicant:

Sui tao 

Study leader:

Zhao mingfeng 

申请注册联系人电话:

Applicant telephone:

+86 13920675495 

研究负责人电话:

Study leader's telephone:

+86 13752640369 

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:

taosui71@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mingfengzhao@sina.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:

天津市南开区复康路24号 

研究负责人通讯地址:

天津市南开区复康路24号 

Applicant address:

24 Fukang Road, Nankai District, Tianjin, China 

Study leader's address:

24 Fukang Road, Nankai District, Tianjin, 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:

天津市第一中心医院血液科 

Applicant's institution:

Department of hematology, Tianjin First Central Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

天津市第一中心医院 

Primary sponsor:

Department of hematology, Tianjin First Central Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路24号 

Primary sponsor's address:

24 Fukang Road, Nankai District, Tianjin, 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):

天津市

市(区县):

 

Country:

China

Province:

Tianjin

City:

 

单位(医院):

天津市第一中心医院

具体地址:

天津市南开区复康路24号

Institution
hospital:

Tianjin First Central Hospital

Address:

24 Fukang Road, Nankai District, Tianjin, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

新诊断的高危成人PH(-)B细胞急性淋巴细胞白血病 

Target disease:

newly diagnosed high-risk adult PH (-) B-ALL 

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+CART治疗联合化疗方案对于新诊断的成人ph阴性的高危B-ALL的治疗效果,同时评估CD19+CART细胞作为一线治疗的安全性 

Objectives of Study:

To evaluate the effect and safety as first-line of CD19+CART combination chemotherapy for the newly diagnosed adult ph negative high-risk B-ALL. 

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:

刚诊断CD19+B- ALL患者,并满足下列条件: 年龄18-65岁 ECOG评分≤2 预后分层为高危,且PH阴性,不适合异体干细胞移植条件或由于条件限制放弃异体干细胞移植 无重要脏器严重功能障碍 

Inclusion criteria

1. newly diagnosed adult ph negative high-risk B-ALL patients with below condition; 2. Aged from 18 to 65 years; 3. ECOG score ≤2; 4. The Prognostic stratification at high risk, and the PH negative, not suitable for allogeneic stem cell transplantation or the rejection of allogeneic stem cell transplantation due to other reason; 5. No significant organ dysfunction. 

排除标准:

1)复发ALL,中枢神经系统急性白血病 2) 孕妇和哺乳期妇女; 3) 3月内参加过其它新药的临床试验者; 4) 肝肾功能异常者;定义为血清转氨酶和胆红素≥正常值上限的1.5倍。肌酐超过正常值上限 5) 依从性差的患者; 6) 研究者认为患者不宜参加本试验的任何其它情况。 7)艾滋抗体、梅毒抗体阳性者; 8) 合并重大疾病不适合化疗的患者 9)体能状态差。 10)患者在入组前6周内参加过其他临床实验 11)患者有精神疾病 12)患者存在药物滥用或成瘾 

Exclusion criteria:

1) relapse ALL, CNS-ALL; 2) pregnant and lactating women; 3) participate clinical trials of other new drugs within 3 months; 4) abnormal liver and kidney function,which defined as 1.5 times higher than the upper limit of serum transaminase and bilirubin.Creatinine exceeds the normal upper limit; 5) patients with poor compliance. 

研究实施时间:

Study execute time:

From2018-04-01To 2021-03-31 

干预措施:

Interventions:

组别:

实验组

样本量:

60

Group:

case series

Sample size:

干预措施:

CD19+CART细胞+化疗

干预措施代码:

 

Intervention:

CD19+CART cells+chemotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津市 

市(区县):

南开区 

Country:

China 

Province:

Tianjin 

City:

nankai 

单位(医院):

天津第一中心医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin first center hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津血液病医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin hematonosis hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

保定 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

Affliated hospital of hebei university  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

贵州省 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵州省人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guizhou people's hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

云南省 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明医科大学第二附属医院 

单位级别:

三甲医院 

Institution
hospital:

the Sencond Affiliated Hospital of Kunming Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山西省 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

大同煤矿总医院 

单位级别:

三甲医院 

Institution
hospital:

WITH the coal group general hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

邯郸市中心医院 

单位级别:

三甲医院 

Institution
hospital:

Handan center hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学天津市肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Tianjin medical university cancer institute & hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

总生存期

指标类型:

主要指标 

Outcome:

Overall Surviva

Type:

Primary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

无进展生存时间

指标类型:

主要指标 

Outcome:

Progress 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:

完全缓解(

指标类型:

次要指标 

Outcome:

Complete Response

Type:

Secondary indicator 

测量时间点:

 

测量方法:

 

Measure time point of outcome:

 

Measure method:

 

指标中文名:

微小残留病

指标类型:

次要指标 

Outcome:

minimal residual 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:

毒副反应

指标类型:

次要指标 

Outcome:

toxic and adverse effects

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:

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:

骨髓液

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:

 

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 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):

本研究为自身前后对照研究,无需随机分组

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

This is a self control study without random grouping

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):

2021.9.http://www.chictr.org.cn/edit.aspx?pid=25674&htm=4

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

2021.9.http://www.chictr.org.cn/edit.aspx?pid=25674&htm=4

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:

病例报告表、EXCEL、SPSS

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

case report form、EXCEL、SPSS

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

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