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Clinical outcomes of dual anti-CD19/CD22 CAR-T cell threapy in pediatric patients with relapsed or refractory B-cell leukemia and lymhpoma
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注册号:

Registration number:

ChiCTR2000032211 

最近更新日期:

Date of Last Refreshed on:

2020-12-29 

注册时间:

Date of Registration:

2020-04-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

CD19/22-CART治疗复发、难治儿童B系急性淋巴细胞白血病和淋巴瘤的临床近远期疗效研究 

Public title:

Clinical outcomes of dual anti-CD19/CD22 CAR-T cell threapy in pediatric patients with relapsed or refractory B-cell leukemia and lymhpoma 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CD19/22-CART治疗复发、难治儿童B系急性淋巴细胞白血病和淋巴瘤的临床近远期疗效研究  

Scientific title:

Clinical outcomes of dual anti-CD19/CD22 CAR-T cell threapy in pediatric patients with r/r B-cell leukemia and lymhpoma 

研究课题代号(代码):

Study subject ID:

TM201928 

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:

李本尚 

研究负责人:

李本尚 

Applicant:

Benshang Li 

Study leader:

Benshang Li 

申请注册联系人电话:

Applicant telephone:

+86 18101893712 

研究负责人电话:

Study leader's telephone:

+86 18101893712 

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:

leebenshang@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

leebenshang@hotmail.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:

上海市东方路1678号 

研究负责人通讯地址:

上海市东方路1678号 

Applicant address:

1678 Dongfang Road, Shanghai, China  

Study leader's address:

1678 Dongfang Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200127 

研究负责人邮政编码:

Study leader's postcode:

200127 

申请人所在单位:

上海交通大学医学院附属上海儿童医学中心 

Applicant's institution:

Shanghai Children's Medical Center affiliated to school of medicine, Shanghai Jiaotong 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:

SCMCIRB-K2015019 

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:

上海交通大学医学院附属上海儿童医学中心伦理委员会  

Name of the ethic committee:

IRB of Shanghai Children's Medical Center affiliated to School of Medicine, Shanghai Jiaotong University  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-05-05 

伦理委员会联系人:

周纬 

Contact Name of the ethic committee:

Zhou Wei 

伦理委员会联系地址:

上海市东方路1678号 

Contact Address of the ethic committee:

1678 Dongfang Road, Shanghai, 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:

上海交通大学医学院附属上海儿童医学中心 

Primary sponsor:

Shanghai Children's Medical Center, Affiliated to Shanghai Jiaotong University, School of Medicine 

研究实施负责(组长)单位地址:

上海市东方路1678号 

Primary sponsor's address:

1678 Dongfang Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属上海儿童医学中心

具体地址:

上海市东方路1678号

Institution
hospital:

Shanghai Children's Medical Center, Affiliated to Shanghai Jiaotong University, School of Medicine

Address:

1678 Dongfang Road

经费或物资来源:

上海市转化医学协同创新中心 

Source(s) of funding:

Shanghai Collaborative Innovation Center for Translational Medicine 

研究疾病:

复发或难治性B细胞白血病和淋巴瘤 

Target disease:

R/R B-cell leukemia and lymhpoma 

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:

研究靶向CD19与CD22 CAR-T细胞治疗儿童复发或难治性B细胞白血病和淋巴瘤的有效性和安全性。 

Objectives of Study:

Safety and efficacy of dual anti-CD19/CD22 CAR-T cell threapy for treating pediatric patients with B cell leukemia and lymhpoma. 

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:

难治性或复发性B细胞血液系统肿瘤(白血病和淋巴瘤)患者,对临床顺应性好,且满足下述条件中至少一种: 1. 两次及以上诱导化疗不缓解(原始+幼稚细胞>5%); 2. 化疗第46天时MRD > 1%; 3. 初治过程中MRD升高至少两次,其中至少一次MRD > 1%; 4. 任何时期骨髓复发,诱导化疗后MRD > 0.1%; 5. 单纯髓外白血病复发(睾白或者脑膜白血病); 6. CD19和/或CD22阳性的处于疾病进展期的B系淋巴系统肿瘤; 所有入组患儿的监护人需签署知情同意书(患儿年龄超过10岁,除监护人签署《知情同意书》外,还应由患者本人签字表达同意参加本项研究),遵照伦理委员会的决定入组治疗。 

Inclusion criteria

Patients must have relapsed or refractory B ALL or lymphoma meeting one of the following disease-specific criteria at least: 1. No remission after two or more induction chemotherapy (blast cells> 5%); 2. MRD > 1% on day 46 of chemotherapy; 3. MRD elevated at least twice during the initial treatment, of which MRD > 1% once at least; 4. BM relapse at any time, MRD> 0.1% after induction chemotherapy; 5. Isolated extramedullary leukemia relapse(testicular or CNS leukemia); All guardians of pediatric patients should sign the informed consent form (if the patient is over 10 years old, the patient should sign it in person for agreeing the participation in this study), which also requires the ethics committee's admission.  

排除标准:

1. 年龄>18周岁; 2. 预计生存期<12周; 3. 基因检测存在CD19抗原突变或结构变异; 4. 骨髓移植后复发患者GVHD严重,需要免疫抑制剂干预; 5. 骨髓移植后复发时间<3月,找不到供体; 6. 肌酐>2.5mg/dl;ALT/AST>5倍正常值;总胆红素>2mg/dl; 7. 无法控制的活动性感染; 8. 乙肝、丙肝处于活动期,或HIV感染; 9. 治疗后早期失访(<3月); 10. 未签署知情同意书或未经伦理委员会同意; 11. 有其它干扰本项研究的系统性疾病存在。 

Exclusion criteria:

1. Aged over 18 years; 2. the expected survival time less than 12 weeks; 3. Mutations or structural variations of CD19 antigen detected by gene examinations; 4. For the patients who relapse after HSCT, those with severe GVHD require the intervention of immunosuppressants; 5. BM relapses less than 3 months without suitable donor; 6. CR > 2.5mg/dl;ALT and AST > 5.0 times the normal range value;total bilirubin > 2mg/dl; 7. Uncontrolled active infections; 8. Active viral hepatitis B or C,or HIV infection; 9. Early loss of visitors after treatment(< 3 months); 10. Without signing the informed consent form or agreement from the ethic committee; 11. With other serious diseases that conflict with this program. 

研究实施时间:

Study execute time:

From2017-01-01To 2022-06-01 

征募观察对象时间:

Recruiting time:

From2017-03-20To 2022-06-01 

干预措施:

Interventions:

组别:

单组

样本量:

100

Group:

Single arm

Sample size:

干预措施:

CD19/CD22 CAR-T细胞

干预措施代码:

Intervention:

CD19 and CD22 CAR-T cells

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属上海儿童医学中心 

单位级别:

三甲 

Institution
hospital:

Shanghai Children's Medical Center, Affiliated to Shanghai Jiaotong University, School of Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

微小残留病灶

指标类型:

主要指标 

Outcome:

MRD

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存时间

指标类型:

主要指标 

Outcome:

overall survive

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

无事件生存

指标类型:

主要指标 

Outcome:

event-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:

细胞因子风暴

指标类型:

副作用指标 

Outcome:

cytokine releasw syndrome

Type:

Adverse events 

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:

外周血

组织:

Sample Name:

Peripheral Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 2 years
最大 Max age 18 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):

本研究为单臂治疗组

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

This study is a single arm of treatment group.

盲法:

N/A

Blinding:

N/A

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

Yes

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):

试验结束6个月后,原始数据上传到指定网站。

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

The raw data was uploaded to a designated website six months after the trial ended.

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:

设计临床试验专用CRF,专人进行纸质记录并录入数据库,保存于研究者处,患者临床病史记录为纸质版,主管医生签字后保存于上海儿童医学中心病案室以备查阅。

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

All the CRFs will be saved.The medical records with the signature of the doctor in charge are all in print edition, which will be saved in the medical record department of SCMC hospital.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-23
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