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Clinical study of cord blood transplantation with modified and dose-reduced BUCY regimen on the treatment of hematological malignancies
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注册号:

Registration number:

ChiCTR1800015259 

最近更新日期:

Date of Last Refreshed on:

2018-03-19 

注册时间:

Date of Registration:

2018-03-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非清髓脐带血造血干细胞移植在血液系统恶性疾病中的应用 

Public title:

Clinical study of cord blood transplantation with modified and dose-reduced BUCY regimen on the treatment of hematological malignancies 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

非清髓脐带血造血干细胞移植在血液系统恶性疾病中的应用 

Scientific title:

Clinical study of cord blood transplantation with modified and dose-reduced BUCY regimen on the treatment of hematological malignancies 

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:

丁家华 

研究负责人:

丁家华 

Applicant:

Ding Jiahua 

Study leader:

Ding Jiahua 

申请注册联系人电话:

Applicant telephone:

+86 13809027048 

研究负责人电话:

Study leader's telephone:

+86 13809027048 

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:

973092642@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

973092642@qq.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:

江苏南京鼓楼区丁家桥87-1 

研究负责人通讯地址:

江苏南京鼓楼区丁家桥87-1 

Applicant address:

87-1 Ding jiaqiao Road, Gulou District, Nanjing, Jiangsu, China 

Study leader's address:

87-1 Ding jiaqiao Road, Gulou District, Nanjing, Jiangsu, China  

申请注册联系人邮政编码:

Applicant postcode:

210009 

研究负责人邮政编码:

Study leader's postcode:

210009 

申请人所在单位:

东南大学附属中大医院 

Applicant's institution:

Zhongda Hospital Southeast 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:

ZDYJLY2016-4 

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:

东南大学附属中大医院医疗技术伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Zhongda Hospital Affiliated to Southeast University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-05-11 

伦理委员会联系人:

陈明 

Contact Name of the ethic committee:

Ming Chen 

伦理委员会联系地址:

江苏南京丁家桥87-1 

Contact Address of the ethic committee:

87-1 Ding jiaqiao Road, Gulou District, Nanjing, Jiangsu, 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:

东南大学附属中大医院 

Primary sponsor:

ZhongDa Hospital Southeast University  

研究实施负责(组长)单位地址:

江苏省南京市鼓楼区丁家桥87号 

Primary sponsor's address:

87 Dingjiaqiao, Gulou District, Nanjing, Jiangsu, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

恶性血液病 

Target disease:

malignant hematological disease  

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:

研究减低剂量、改良的传统BUCY预处理方案(以下简称该方案)的脐血移植(UCBT)治疗血液系统恶性疾病的临床疗效(主要观察中性粒细胞植入率,以及总生存率) 

Objectives of Study:

To investigate the clinical efficacy of reduced-dose, modified conventional BUCY conditioning regimen (hereinafter referred to as the protocol) for the treatment of hematologic malignancies (mainly observation of neutrophil engraft rate, and overall survival) 

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)年龄大于2岁、小于65岁(2)缺乏HLA全相合同胞供者,和(或)紧急需要移植(3)复苏前有核细胞大于2.5x107/kg,CD34大于1.2x105/kg;如果单份脐血细胞数不充足,可选择双份脐血(4)卡氏评分≥60(5)获得患者或家属签署的知情同意书 。 

Inclusion criteria

(1) aged 2 to 65 years; (2) absence a HLA-matched sibling donor, and/or in need of an urgent allograft; (3) at freezing, nucleated cell dose should be>2.5x107/kg and CD34 cell dose >1.2x105/kg; if the cell dose was insufficient with a single CBU, double cord blood unit was used; (4) the score of Karnofsky ≥60; (5) Signed written informed consent.  

排除标准:

(1)有严重的脏器功能障碍或疾病,如心脏、肝脏、肾脏和胰腺等严重疾病和功能障碍者(2)妊娠患者(3)受试者和/或授权家属拒绝行UCBT治疗者(4)研究者认为可损害受试者安全、使研究结果面临不必要风险的任何危及生命的疾病、身体状况或器官系统功能障碍;药物依赖者;未控制的精神疾病受试者;认知功能障碍者(5)研究者认为不适合此研究者  

Exclusion criteria:

(1) Serious viscera dysfunction or disease, such as serious diseases and function disorder in heart, liver, kidney and pancreas; (2) Patients with pregnancy; (3) Participants and/or authorized family members refused to accept UCBT; (4) Researchers believe that can damage the unnecessary risks to safety, make the results of the study subjects any life-threatening illness, condition or organ system dysfunction; drug dependence; uncontrolled mental disease; cognitive impairment; (5) Researchers think that the patient doesn't fit into the study.  

研究实施时间:

Study execute time:

From2018-03-20To 2021-03-31 

干预措施:

Interventions:

组别:

Case series

样本量:

75

Group:

Case series

Sample size:

干预措施:

改良、减低剂量BUCY

干预措施代码:

Intervention:

modified and dose-reduced BUCY

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

NanJing 

单位(医院):

东南大学附属中大医院 

单位级别:

三级甲等 

Institution
hospital:

ZhongDa Hospital Southeast University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

中性粒细胞累积植入率

指标类型:

主要指标 

Outcome:

Cumulative rate of neutrophil engraftment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板累积植入率

指标类型:

主要指标 

Outcome:

Cumulative rate of platelet engraftment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存率

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:

移植物抗宿主病

指标类型:

次要指标 

Outcome:

GVHD

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

嵌合

指标类型:

次要指标 

Outcome:

chimerism

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

复发

指标类型:

次要指标 

Outcome:

relapse

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

移植相关死亡率

指标类型:

次要指标 

Outcome:

TRM

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:

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 2 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):

Non-randomization

盲法:

Blinding:

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):

暂未定

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

Not yet

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:

ResMan数据库

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

ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-03-19
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