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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
浙江大学医学院附属第一医院 |
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Applicant's institution: |
first affiliated hospital of Zhejiang University, School of medicine |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Medical ethics committee of the first affiliated hospital, College of Medicine, Zhejiang University |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
Bone marrow transplantation center,first affiliated hospital of Zhejiang University,school of medicine |
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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 |
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Primary sponsor's address: |
79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
国家自然科学基金 |
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Source(s) of funding: |
the National Natural Science Foundation of China |
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研究疾病: |
白血病 |
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Target disease: |
leukemia |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
治疗新技术临床试验 | ||||||||||||||||||||||
Study phase: |
New Treatment Measure Clinical Study |
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研究目的: |
评估CD19-CAR-T治疗方案的安全性,有效性和可行性 |
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Objectives of Study: |
to evaluate the security, effectiveness and feasibility of CD9-CAR-T therapy. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
单臂 |
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Study design: |
Single arm |
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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。 |
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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. |
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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。 |
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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: |
从From2015-06-01至To 2015-12-31 |
征募观察对象时间: Recruiting time: |
从From2015-06-01至To 2015-10-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
no |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
no |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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): |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
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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: |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据管理委员会: Data Managemen Committee: |
暂未确定/Not yet |