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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600126544 |
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最近更新日期: Date of Last Refreshed on: |
2026-06-10 22:16:51 |
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注册时间: Date of Registration: |
2026-06-10 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
评估聚乙二醇干扰素α-2b注射液联合TKI治疗慢性期慢性髓性白血病患者疗效与安全性的临床研究 |
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Public title: |
Clinical study on the efficacy and safety of Peginterferon alfa-2b injection combined with TKI in the treatment of patients with chronic-phase chronic myeloid leukemia |
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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: |
评估聚乙二醇干扰素α-2b注射液联合TKI治疗慢性期慢性髓性白血病患者疗效与安全性的临床研究 |
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Scientific title: |
Clinical study on the efficacy and safety of Peginterferon alfa-2b injection combined with TKI in the treatment of patients with chronic-phase chronic myeloid leukemia |
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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: |
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申请注册联系人: |
侯传东 |
研究负责人: |
卢学春 |
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Applicant: |
Hou Chuandong |
Study leader: |
Lu Xuechun |
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申请注册联系人电话: Applicant telephone: |
+86 186 2303 6987 |
研究负责人电话: Study leader's telephone: |
+86 153 1169 9983 |
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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: |
hou_cd@163.com |
研究负责人电子邮件: Study leader's E-mail: |
luxuechun@301hospital.com.cn |
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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: |
中国北京市海淀区复兴路28号 |
研究负责人通讯地址: |
中国北京市海淀区复兴路28号 |
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Applicant address: |
28 Fuxing Road, Haidian District, Beijing, China |
Study leader's address: |
28 Fuxing Road, Haidian District, Beijing, China |
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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: |
中国人民解放军总医院第二医学中心 |
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Applicant's institution: |
The Second Medical Center of Chinese PLA General Hospital |
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研究负责人所在单位: |
中国人民解放军总医院第二医学中心 |
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Affiliation of the Leader: |
The Second Medical Center of Chinese PLA General Hospital |
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是否获伦理委员会批准: |
是/Yes |
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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: |
伦审第S2025-1020-02号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中国人民解放军总医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of the Chinese People's Liberation Army General Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2026-05-07 00:00:00 |
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伦理委员会联系人: |
曹江 |
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Contact Name of the ethic committee: |
Cao Jiang |
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伦理委员会联系地址: |
中国北京市海淀区复兴路28号 |
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Contact Address of the ethic committee: |
28 Fuxing Road, Haidian District, Beijing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 6693 7166 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
中国人民解放军总医院第二医学中心 |
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Primary sponsor: |
The Second Medical Center of Chinese PLA General Hospital |
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研究实施负责(组长)单位地址: |
中国北京市海淀区复兴路28号 |
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Primary sponsor's address: |
28 Fuxing Road, Haidian District, Beijing, 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: |
其他(研究者自发) |
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Source(s) of funding: |
Other(Investigator-Sponsored Research Funds) |
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Target disease: |
Chronic-phase chronic myeloid leukemia |
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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: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.探讨聚乙二醇干扰素α-2b联合TKI治疗对初治CP-CML患者的疗效与安全性; 2.探讨聚乙二醇干扰素α-2b联合TKI治疗对现阶段未达到治疗最佳目标的CP-CML患者的疗效与安全性。 |
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Objectives of Study: |
1. To explore the efficacy and safety of peginterferon alfa-2b combined with TKI in the treatment of newly diagnosed CP-CML patients. 2. To explore the efficacy and safety of peginterferon alfa-2b combined with TKI in the treatment of CP-CML patients who have not reached the best treatment target at present. |
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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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纳入标准: |
队列一: 入选标准(满足全部入选标准方可入选) 1. 年龄>=18岁且<=90岁,男女不限; 2. 确诊为费城染色体阳性(Ph+)的慢性期慢性髓性白血病患者(参考《慢性髓性白血病诊疗指南(2022年版) 》); 3. 确诊为常见的BCR-ABL转录本类型(M-BCR-ABL); 4. 初治组:确诊后(<=3个月内)首次接受治疗,既往未接受过任何TKI药物; 5. 自愿签署知情同意。 队列二: 入选标准(满足全部入选标准方可入选) 1. 年龄>=18岁且<=90岁,男女不限; 2. 确诊为费城染色体阳性(Ph+)的慢性期慢性髓性白血病患者(参考《慢性髓性白血病诊疗指南(2022年版) 》); 3. 确诊为常见的BCR-ABL转录本类型(M-BCR-ABL); 4. TKI治疗未能达到理想缓解状态的慢性期慢粒患者: (1) 3个月未实现早期分子学反应(EMR,BCR::ABL1 IS <=10%); (2) 6个月未实现完全细胞遗传学反应(CCyR,BCR::ABL1 IS <=1%); (3) 12个月未实现主要分子学反应(MMR,BCR::ABL1 IS <=0.1%/MR 3.0); (4) 任意时间未实现深度分子学反应(BCR::ABL1 IS <=0.01%/MR 4.0); 5. 自愿签署知情同意。 |
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Inclusion criteria |
Cohort 1: Inclusion criteria (all inclusion criteria must be met to be eligible for inclusion) 1. Age >= 18 years and <= 90 years, with no gender restrictions; 2. Confirmed as chronic-phase chronic myeloid leukemia patients with Philadelphia chromosome positive (Ph+) (refer to the "Chronic Myeloid Leukemia Diagnosis and Treatment Guidelines (2022 Edition)"); 3. Confirmed as having the common BCR-ABL transcript type (M-BCR-ABL); 4. Naive group: First treatment within 3 months after diagnosis, and no previous treatment with any TKI drugs; 5. Voluntary signing of informed consent. Cohort 2: Inclusion Criteria (All inclusion criteria must be met to be eligible for inclusion) 1. Age >= 18 years and <= 90 years, with no gender restrictions; 2. Confirmed as chronic-phase chronic myeloid leukemia patients with Philadelphia chromosome positive (Ph+) (refer to the "Chronic Myeloid Leukemia Diagnosis and Treatment Guidelines (2022 Edition)"); 3. Confirmed as having the common BCR-ABL transcript type (M-BCR-ABL); 4. Chronic-phase CML patients who have not achieved an ideal remission state with TKI treatment: (1) Failure to achieve early molecular response (EMR, BCR::ABL1 IS <=10%) within 3 months; (2) Failure to achieve complete cytogenetic response (CCyR, BCR::ABL1 IS <=1%) within 6 months; (3) Failure to achieve major molecular response (MMR, BCR::ABL1 IS <=0.1%/MR 3.0) within 12 months; (4) Failure to achieve deep molecular response (BCR::ABL1 IS <=0.01%/MR 4.0) at any time; 5. Voluntary signing of informed consent. |
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排除标准: |
排除标准(满足1项排除标准即排除) 1. 费城染色体阴性(Ph-),除M-BCR-ABL以外其他的转录本类型; 2. 对TKI类药物、干扰素及其药物成分过敏者; 3. 孕妇、计划妊娠及哺乳期妇女,有生育计划的男性; 4. 中性粒细胞计数<1.5×10^9/L,血小板计数<90×10^9/L; 5. 肌酐高于1.5倍正常值上限(ULN),总胆红素>=2ULN,ALT>2.5ULN,AST>2.5ULN; 6. 既往接受造血干细胞移植或细胞免疫治疗的患者; 7. 本人及血缘近亲属(父母、兄弟姐妹等)有严重的精神病史,尤其是抑郁症。严重的精神病定义为重症抑郁症或精神病、自杀企图、因精神病而住院或因精神病而有一段时间能力丧失; 8. 有免疫介导的疾病史(如炎症性肠病、特发性血小板减少性紫癜、红斑狼疮、自身免疫性溶血性贫血、硬皮病、重度银屑病、类风湿性关节炎)或自身免疫抗体水平异常升高; 9. 重度癫痫史或当前正在使用抗癫痫药物治疗; 10. 控制不稳定的糖尿病、高血压、甲状腺疾病等; 11. 重度视网膜病变史或由其他证据表明为视网膜病变患者; 12. 合并心、肺、肾、脑等重要脏器严重疾病患者; 13. 合并其他恶性肿瘤患者; 14. 合并活动性甲肝、丙肝、丁肝、戊肝、HIV感染; 15. 任何器官移植史以及现存功能性移植物(角膜或毛发移植除外); 16. 由研究者判定不适合参加本项临床试验者。 |
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Exclusion criteria: |
Exclusion criteria (meeting any one of the exclusion criteria will result in exclusion) 1. Philadelphia chromosome negative (Ph-), except for M-BCR-ABL transcript types; 2. Allergic to TKI drugs, interferon and their drug components; 3. Pregnant women, women planning pregnancy and lactating women, and men with plans for fatherhood; 4. Neutrophil count < 1.5×10^9/L, platelet count < 90×10^9/L; 5. Creatinine > 1.5 times the upper limit of normal (ULN), total bilirubin >= 2ULN, ALT > 2.5ULN, AST > 2.5ULN; 6. Patients who have previously received hematopoietic stem cell transplantation or cellular immunotherapy; 7. Individuals and their close blood relatives (parents, siblings, etc.) with a history of severe mental illness, especially depression. Severe mental illness is defined as major depressive disorder or psychosis, suicide attempts, hospitalization due to mental illness, or a period of incapacity due to mental illness; 8. History of immune-mediated diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoantibodies; 9. History of severe epilepsy or currently receiving antiepileptic drug treatment; 10. Unstable diabetes, hypertension, thyroid disease, etc.; 11. History of severe retinopathy or other evidence indicating retinopathy; 12. Patients with severe diseases of important organs such as heart, lungs, kidneys, and brain; 13. Patients with other malignant tumors; 14. Active hepatitis A, C, D, E, or HIV infection; 15. Any history of organ transplantation and existing functional grafts (except for corneal or hair transplantation); 16. Patients deemed unsuitable for participation in this clinical trial by the investigator. |
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研究实施时间: Study execute time: |
从 From 2026-01-01 00:00:00至 To 2029-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2026-06-12 00:00:00 至 To 2028-05-15 00:00:00 |
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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: |
尚未开始 Not yet 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): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
无 |
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Blinding: |
None |
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是否共享原始数据: IPD sharing |
No |
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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): |
不共享 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Don't share |
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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: |
数据管理:使用电子采集和管理系统 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Data management: Utilizing electronic collection and management systems |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |