审核状态: Project audit state: |
通过审核 Successful |
注册号: Registration number: |
ChiCTR-TRC-13004054 |
最近更新时间: Date of Last Refreshed on: |
2016/6/19 21:08:09 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
填写语言: |
中文和英文 |
Language: |
Chinese And English |
注册题目: |
比较口服四硫化四砷+维甲酸和静脉三氧化二砷+维甲酸治疗非高危急性早幼粒细胞白血病的有效性性的随机对照III期临床试验 |
Public title: |
A Randomized Phase III Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia |
注册题目简写: |
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Public title acronym: |
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研究课题的正式科学名称: |
比较口服四硫化四砷+维甲酸和静脉三氧化二砷+维甲酸治疗非高危急性早幼粒细胞白血病的有效性性的随机对照III期临床试验 |
Scientific title: |
A Randomized Phase 3 Study to Compare Oral Tetra-arsenic Tetra-sulphide Formula Plus ATRA Versus Intravenous Arsenic Trioxide Plus ATRA for Newly Diagnosed, Non High-Risk Acute Promyelocytic Leukemia |
研究课题的正式科学名称简写: |
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Scientific title acronym: |
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研究课题代号(代码): Study subject ID: |
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在其它机构的注册号: Secondary ID: |
申请注册联系人: |
主鸿鹄 |
研究负责人: |
黄晓军 |
Applicant: |
Hong-Hu Zhu |
Study leader: |
Xiao-Jun Huang |
申请注册联系人电话: Applicant telephone: |
+86 13671232272 |
研究负责人电话: Study leader's telephone: |
+86 13701389625 |
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: |
zhuhhdoc@163.com |
研究负责人电子邮件: Study leader's E-mail: |
xjhrm@medmail.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): |
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申请注册联系人通讯地址: |
北京西直门南大街11号 |
研究负责人通讯地址: |
北京西直门南大街11号 |
Applicant address: |
11 South Xizhimen Street, Beijing |
Study leader's address: |
11 South Xizhimen Street, Beijing |
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: |
北京大学人民医院 |
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Applicant's institution: |
Peking University People's Hospital |
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: |
2013-11 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
北京大学人民医院医学伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Peking University People’s Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-11-22 | ||
国家FDA批准文号: Approved No. of SFDA: |
国家FDA批准附件: Approved file of SFDA: |
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国家FDA批准日期: Date of approved by SFDA: |
研究实施负责(组长)单位: |
北京大学人民医院 |
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Primary sponsor: |
Peking University People's Hospital Address |
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研究实施负责(组长)单位地址: |
北京西直门南大街11号 |
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Primary sponsor's address: |
11 South Xizhimen Street, Beijing |
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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: |
自筹 |
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Source(s) of funding: |
No |
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研究疾病: |
急性早幼粒细胞白血病 |
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Target disease: |
Acute Promyelocytic 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: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
III期临床试验 | ||||||||||||||||||||||
Study phase: |
3 |
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研究目的: |
比较口服复方黄黛片+维甲酸和静脉亚砷酸+维甲酸治疗非高危急性早幼粒细胞白血病的有效性 |
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Objectives of Study: |
To compare the efficacy of oral tetra-arsenic tetra-sulphide formula plus ATRA versus intravenous ATO plus ATRA for newly diagnosed, non high-risk acute promyelocytic leukemia. |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
1.初诊APL病人(WHO 2008诊断分类) 2.年龄18-70岁 3.体力评分为0-2(WHO) 4.治疗前WBC ≤ 10 x 109/L 5.肝功能:ALT和AST≤2.5倍正常值高限,胆红素≤2倍正常值高限 6.血肌酐 ≤ 3.0 mg/dL (≤ 260 μmol/L); 7. 签署知情同意书 |
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Inclusion criteria |
1. Newly diagnosed APL by cytomorphology, confirmed also by molecular analysis; 2. To be aged 18 to 71 years; 3. WHO performance status 0-2 included;4.white blood cell at diagnosis <=10*10^9/L; 5. Serum total bilirubin <=3.0 mg/dL (<=51umol/L); 6. Serum creatinine <=3.0 mg/dL (<=260 umol/L); 7.Signed written informed consent. |
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排除标准: |
1. 伴有脑出血 2.妊娠 3.不签署知情同意书 4.严重的心律失常,ECG异常(QT>500ms)。 5.患有精神疾病或其他情况无法按方案进行 |
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Exclusion criteria: |
1. cerebral ischemic; 2. pregnancy; 3. Subjects who cannot sign written informed consent; 4. Significant arrhythmias, EKG abnormalities or neuropathy; 5. Subjects who cannot comply with the study. |
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研究实施时间: Study execute time: |
从From2013-12-11至To 2016-12-31 |
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: |
结束 Completed |
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): |
由中央随机系统的计算机产生随机号 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
computer generated |
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UTN(全球唯一识别码): |
盲法: |
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Blinding: |
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试验完成后的统计结果: |
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Calculated Results ater
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研究负责(组长)单位: |
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Organizer institution (leader institution): |
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资料收集汇总单位: |
6M |
Data collection Institution: |
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资料管理单位: |
Not stated |
Data management Institution: |
Not stated |
资料分析单位: |
Not stated |
Data analysis Institution: |
Not stated |