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Exploration of different treatment methods and curative effects after the first remission achieved by azacitidine combined with veneclax in the first treatment of acute myeloid leukemia in the elderly
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注册号:

Registration number:

ChiCTR2100054281 

最近更新日期:

Date of Last Refreshed on:

2022-07-05 

注册时间:

Date of Registration:

2021-12-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

此为补注册,需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册 老年初治急性髓系白血病阿扎胞苷联合维奈克拉治疗获得首次缓解后不同治疗方法及疗效探索 

Public title:

Exploration of different treatment methods and curative effects after the first remission achieved by azacitidine combined with veneclax in the first treatment of acute myeloid leukemia in the elderly 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

老年初治急性髓系白血病阿扎胞苷联合维奈克拉治疗获得首次缓解后不同治疗方法及疗效探索 

Scientific title:

Exploration of different treatment methods and curative effects after the first remission achieved by azacitidine combined with veneclax in the first treatment of acute myeloid leukemia in the elderly 

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:

王怡 

研究负责人:

欧阳桂芳 

Applicant:

Wang Yi 

Study leader:

Ouyang Guifang 

申请注册联系人电话:

Applicant telephone:

+86 13858375069 

研究负责人电话:

Study leader's telephone:

+86 13967810405 

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:

zjnbwangyi@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ouyangguifang2000@yahoo.com.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:

浙江宁波柳汀街59号 

研究负责人通讯地址:

浙江宁波柳汀街59号 

Applicant address:

59 Liuting Street, Ningbo, Zhejiang 

Study leader's address:

59 Liuting Street, Ningbo, Zhejiang 

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:

宁波市第一医院 

Applicant's institution:

Ningbo First Hospital 

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:

2021-R053 

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:

宁波市第一医院伦理委员会 

Name of the ethic committee:

Ningbo First Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-08-13 

伦理委员会联系人:

陈少莹 

Contact Name of the ethic committee:

Chen Shaoying 

伦理委员会联系地址:

浙江宁波柳汀街59号 

Contact Address of the ethic committee:

59 Liuting Street, Ningbo, Zhejiang 

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:

宁波市第一医院血液科 

Primary sponsor:

Ningbo First Hospital 

研究实施负责(组长)单位地址:

浙江宁波柳汀街59号 

Primary sponsor's address:

59 Liuting Street, Ningbo, Zhejiang 

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):

宁波

Country:

China

Province:

Zhejiang

City:

Ningbo

单位(医院):

宁波市第一医院

具体地址:

柳汀街59号

Institution
hospital:

Ningbo First Hospital

Address:

59 Liuting Street

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

急性髓系白血病 

Target disease:

Acute myeloid leukemia (AML) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究探索阿扎胞苷联合维奈克拉治疗老年初治急性髓系白血病(AML)获得第1次完全缓解(CR1)后不同治疗方法的疗效与安全性。 

Objectives of Study:

This study explored the efficacy and safety of azacitidine combined with veneclax in the treatment of elderly patients with untreated acute myeloid leukemia (AML) after achieving the first complete remission (CR1). 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.自愿参加临床研究;本人或法定监护人完全了解、知情本研究并签署知情同意书;愿意遵循并能完成所有试验程序; 2.老年AML患者(大于60岁),所有患者的诊断均符合2016年WHO的急性髓细胞白血病诊断标准; 3.1个或2个疗程阿扎胞苷联合维奈克拉诱导化疗达到首次CR; 4.体能状态ECOG评分≤2分。 

Inclusion criteria

1. Voluntarily participate in clinical research; I or my legal guardian fully understand and know this research and sign the informed consent; be willing to follow and be able to complete all experimental procedures; 2. Elderly AML patients (over 60 years old), all patients were diagnosed in accordance with the 2016 WHO diagnostic criteria for acute myeloid leukemia; 3. 1 or 2 courses of azacitidine combined with veneclax induction chemotherapy to achieve the first CR; 4. Physical performance status ECOG score <= 2 points. 

排除标准:

1.有其他肿瘤病史; 2.阿扎胞苷联合维奈克拉2疗程未获得缓解的患者; 3.不能控制的活动性感染; 4.HIV; 5.活动性肝炎经过抗病毒治疗HBV-DNA拷贝数不能控制在2*10^3/ml以内。 

Exclusion criteria:

1. Have a history of other tumors; 2. Patients who did not achieve remission after 2 courses of azacitidine combined with veneclax; 3. Uncontrolled active infection; 4. HIV; 5. Active hepatitis can not be controlled within 2*10^3/ml after antiviral treatment. 

研究实施时间:

Study execute time:

From2021-05-01To 2024-04-30 

征募观察对象时间:

Recruiting time:

From2021-05-01To 2024-04-30 

干预措施:

Interventions:

组别:

微移植1组

样本量:

10

Group:

Microtransplant group 1

Sample size:

干预措施:

阿扎胞苷+维奈克拉+中剂量阿糖胞苷+微移植

干预措施代码:

Intervention:

Azacitidine+Venecla+Medium-dose Cytarabine+Microtransplantation

Intervention code:

组别:

微移植2组

样本量:

10

Group:

Microtransplant group 2

Sample size:

干预措施:

阿扎胞苷+维奈克拉+微移植

干预措施代码:

Intervention:

Azacitidine+Venecla+Microtransplantation

Intervention code:

组别:

对照组

样本量:

10

Group:

Control group

Sample size:

干预措施:

阿扎胞苷+维奈克拉

干预措施代码:

Intervention:

Azacitidine+Venecla

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波第一医院 

单位级别:

三级甲等 

Institution
hospital:

Ningbo First Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

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:

无白血病生存

指标类型:

主要指标 

Outcome:

Leukemia-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:

安全性

指标类型:

主要指标 

Outcome:

Safety

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

耐受性

指标类型:

主要指标 

Outcome:

Tolerance

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:

骨髓

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 60 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):

本研究为随机对照、前瞻性临床试验,计划入组30例筛选合格的患者,阿扎胞苷联合维奈克拉诱导获得缓解,巩固治疗进行随机分组:A)微移植1组(n=10):阿扎胞苷+维奈克拉+中剂量阿糖胞苷+微移植×3次;B) 微移植2组(n=10):阿扎胞苷+维奈克拉+微移植×3次;C)对照组(n=10):阿扎胞苷+维奈克拉;

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

This study was A randomized controlled, prospective clinical trial, in which 30 eligible patients were planned to be enrolled, and azacabine combined with venecola induced remission. Consolidation therapy was randomly divided into: A) microtransplantation group 1 (n=10) : azacabine + venecola + medium dose cytarabine +

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):

是否共享原始数据:

IPD sharing

No

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):

No published

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

No published

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:

No published

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

No published

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-12-12
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