ChiCTR2600126544 版本V1.0 版本创建时间2026/06/10 22:17:00 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2600126544 

最近更新日期:

Date of Last Refreshed on:

2026-06-10 22:16:51 

注册时间:

Date of Registration:

2026-06-10 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

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

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

注册题目简写:

English Acronym:

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

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

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:

侯传东 

研究负责人:

卢学春 

Applicant:

Hou Chuandong 

Study leader:

Lu Xuechun 

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

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:

hou_cd@163.com

研究负责人电子邮件:

Study leader's E-mail:

luxuechun@301hospital.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:

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

Applicant address:

28 Fuxing Road, Haidian District, Beijing, China

Study leader's address:

28 Fuxing Road, Haidian District, Beijing, 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:

申请人所在单位:

中国人民解放军总医院第二医学中心

Applicant's institution:

The Second Medical Center of Chinese PLA General Hospital

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

Affiliation of the Leader:

The Second Medical Center of Chinese PLA General Hospital

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

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

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

Name of the ethic committee:

Medical Ethics Committee of the Chinese People's Liberation Army General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2026-05-07 00:00:00

伦理委员会联系人:

曹江

Contact Name of the ethic committee:

Cao Jiang

伦理委员会联系地址:

中国北京市海淀区复兴路28号

Contact Address of the ethic committee:

28 Fuxing Road, Haidian District, Beijing, China

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:

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

Primary sponsor:

The Second Medical Center of Chinese PLA General Hospital

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

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院第二医学中心

具体地址:

中国北京市海淀区复兴路28号

Institution
hospital:

The Second Medical Center of Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源:

其他(研究者自发)

Source(s) of funding:

Other(Investigator-Sponsored Research Funds)

Target disease:

Chronic-phase chronic myeloid leukemia

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

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。  

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.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

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。

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.

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。

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.

研究实施时间:

Study execute time:

From 2026-01-01 00:00:00 To 2029-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-12 00:00:00 To 2028-05-15 00:00:00  

干预措施:

Interventions:

组别:

PEG-IFNα-2b联合TKI组(队列一)

样本量:

115

Group:

The PEG-IFNα-2b combined with TKI group(Cohort 1 )

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

TKI组(队列一)

样本量:

115

Group:

TKI group(Cohort 1)

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

PEG-IFNα-2b联合TKI组(队列二)

样本量:

60

Group:

The PEG-IFNα-2b combined with TKI group(Cohort 2 )

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京同仁医院 

单位级别:

三甲 

Institution
hospital:

Beijing Tongren Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京天坛医院 

单位级别:

三甲 

Institution
hospital:

Beijing Tiantan Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军火箭军总医院 

单位级别:

三甲 

Institution
hospital:

Rocket Army Characteristic Medical Center, Chinese People's Liberation Army General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第四医学中心 

单位级别:

三甲 

Institution
hospital:

Fourth Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第八医学中心 

单位级别:

三甲 

Institution
hospital:

Eighth Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军空军总医院 

单位级别:

三甲 

Institution
hospital:

Air Force Medical Center of the Chinese People's Liberation Army

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三甲 

Institution
hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第九医学中心 

单位级别:

三甲 

Institution
hospital:

Ninth Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲 

Institution
hospital:

Peking University First Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第一医学中心 

单位级别:

三甲 

Institution
hospital:

First Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第七医学中心 

单位级别:

三甲 

Institution
hospital:

Seventh Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京医院 

单位级别:

三甲 

Institution
hospital:

Beijing Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东方医院 

单位级别:

三甲 

Institution
hospital:

Dongfang Hospital, Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学宣武医院 

单位级别:

三甲 

Institution
hospital:

Xuanwu Hospital of Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京安贞医院 

单位级别:

三甲 

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三甲 

Institution
hospital:

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第五医学中心 

单位级别:

三甲 

Institution
hospital:

Fifth Medical Center of Chinese PLA General Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属复兴医院 

单位级别:

三级 

Institution
hospital:

Fuxing Hospital Affiliated to Capital Medical University

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京清华长庚医院 

单位级别:

三级 

Institution
hospital:

Beijing Tsinghua Changgung Hospital

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市垂杨柳医院 

单位级别:

三级 

Institution
hospital:

Chuiyangliu Hospital of Beijing

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京陆道培医院 

单位级别:

三级 

Institution
hospital:

Ludaopei Hospital of Beijing

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市石景山医院 

单位级别:

三级 

Institution
hospital:

Shijingshan Hospital of Beijing

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京潞河医院 

单位级别:

三级 

Institution
hospital:

Luhe Hospital Affiliated to Capital Medical University

Level of the institution:

Tertiary

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京博仁医院 

单位级别:

二级 

Institution
hospital:

Boren Hospital of Beijing

Level of the institution:

Secondary

测量指标:

Outcomes:

指标中文名:

治疗48周获得深层分子学反应(DMR)的患者比例(队列一)

指标类型:

主要指标

Outcome:

The proportion of patients achieving a deep molecular response (DMR) after 48 weeks of treatment(Cohort 1)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗48周获得主要分子学反应(MMR)的患者比例(队列一)

指标类型:

次要指标

Outcome:

The proportion of patients who achieved the primary molecular response (MMR) after 48 weeks of treatment(Cohort 1)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗24周获得MMR、DMR的患者比例(队列一)

指标类型:

次要指标

Outcome:

The proportion of patients achieving MMR and DMR after 24 weeks of treatment(Cohort 1)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗第12周、第24周、第36周和第48周的完全血液学反应(CHR)率(队列一)

指标类型:

次要指标

Outcome:

The complete hematological response (CHR) rates at the 12th, 24th, 36th and 48th weeks of treatment(Cohort 1)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗第12周、第24周、第36周和第48周的完全细胞遗传学反应(CCyR)率(队列一)

指标类型:

次要指标

Outcome:

The complete cytogenetic response (CCyR) rates at the 12th, 24th, 36th and 48th weeks of treatment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗第12周、第24周、第36周和第48周的BCR-ABL基因负荷较基线的变化(队列一)

指标类型:

次要指标

Outcome:

The changes in BCR-ABL gene load compared to the baseline at weeks 12, 24, 36, and 48 of treatment(Cohort 1)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PEG-IFNα-2b 联合TKI治疗48周后能达到下一阶段治疗最佳目标的患者比例(队列 二)

指标类型:

主要指标

Outcome:

The proportion of patients who can reach the optimal target for the next stage of treatment after 48 weeks of treatment with PEG-IFNα-2b combined with TKI(Cohort 2)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性评估包括不良事件,生命体征、实验室检查、影像学检查变化(队列二)

指标类型:

次要指标

Outcome:

The safety assessment includes adverse events, vital signs, laboratory test results, and changes in imaging examinations(Cohort 2).

Type:

Secondary 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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

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

None

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

盲法:

Blinding:

None

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):

不共享

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

Don't share

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

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2026-06-10 22:16:51