中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600122074
最近更新日期： Date of Last Refreshed on：	2026-04-08 17:07:35
注册时间： Date of Registration：	2026-04-08 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	维奈克拉用于急性早幼粒细胞白血病诱导治疗期白细胞升高的疗效及经济性研究
Public title：	Efficacy and Economic Impact of Venetoclax for Leukocytosis During Induction Therapy in Acute Promyelocytic Leukemia (APL)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	维奈克拉用于急性早幼粒细胞白血病诱导治疗期白细胞升高的疗效及经济性研究
Scientific title：	A Study on the Efficacy and Cost-Effectiveness of Venetoclax in Managing Leukocytosis During Induction Therapy for Acute Promyelocytic 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：	李洪丽	研究负责人：	李洪丽
Applicant：	Li Hongli	Study leader：	Li Hongli
申请注册联系人电话： Applicant telephone：	+86 539 803 7801	研究负责人电话： Study leader's telephone：	+86 539 803 7801
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：	18396761396@163.com	研究负责人电子邮件： Study leader's E-mail：	18396761396@163.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：	山东省临沂市兰山区解放路东段27号	研究负责人通讯地址：	山东省临沂市兰山区解放路东段27号
Applicant address：	No. 27 Jiefang Road East Section, Lanshan District, Linyi City, Shandong province	Study leader's address：	No. 27 Jiefang Road East Section, Lanshan District, Linyi City, Shandong province
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：	临沂市人民医院
Applicant's institution：	Linyi People's Hospital
研究负责人所在单位：	临沂市人民医院
Affiliation of the Leader：	Linyi People's Hospital

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：	科技伦审第(202511-H-041)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：	临沂市人民医院科技伦理委员会
Name of the ethic committee：	Science and Technology Ethics Committee, Linyi People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-26 00:00:00
伦理委员会联系人：	尹甲伟
Contact Name of the ethic committee：	Yin Jiawei
伦理委员会联系地址：	山东省临沂市兰山区解放路东段27号
Contact Address of the ethic committee：	No. 27 Jiefang Road East Section, Lanshan District, Linyi City, Shandong province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 539 8603816	伦理委员会联系人邮箱： Contact email of the ethic committee：	yinjiawei1987@163.com

研究实施负责（组长）单位：

临沂市人民医院

Primary sponsor：

Linyi People's Hospital

研究实施负责（组长）单位地址：

山东省临沂市兰山区解放路东段27号

Primary sponsor's address：

No. 27 Jiefang Road East Section, Lanshan District, Linyi City, Shandong province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	临沂市人民医院	具体地址：	山东省临沂市兰山区解放路东段27号
Institution hospital：	Linyi People's Hospital	Address：	No. 27 Jiefang Road East Section, Lanshan District, Linyi City, Shandong province

经费或物资来源：

新锐肿瘤转化医学课题项目

Source(s) of funding：

China Foundation for the Development of Medical and Health Care Industry

研究疾病：

急性早幼粒细胞白血病

Target disease：

acute promyelocytic leukemia,APL

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：

上市后药物

Study phase：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

基于APL细胞高表达BCL-2且对维奈克拉（Venetoclax, Ven）敏感的特性，本研究创新性地将维奈克拉纳入APL减白治疗策略，旨在为APL诱导期高白治疗提供更优的靶向干预策略。主要目的：本研究创新性的将维奈克拉纳入APL减白治疗策略。观察WBC下降速度及峰值控制（7天内WBC降至<4×10^9/L的比例）次要目的：1、达CMR疗程；2、住院时间；3、住院费用；4、降白药物应用天数；5、凝血功能恢复时间；6、血小板输注次数；7、血浆输注量。

Objectives of Study：

Based on the characteristic that APL cells highly express BCL-2 and are sensitive to venetoclax (Ven), this study innovatively incorporated venetoclax into the APL leukopenia treatment strategy, aiming to provide a more optimal targeted intervention strategy for high white blood cell count control during the induction period of APL. Main objective: This study innovatively incorporated venetoclax into the APL leukopenia treatment strategy. Observe the rate of WBC decline and peak control (the proportion of WBC dropping to < 4×10^9/L within 7 days) Secondary objectives: 1. Reach CMR treatment course; 2. Hospitalization time; 3. Hospitalization cost; 4. Number of days of white blood cell reduction drugs application; 5. Recovery time of coagulation function; 6. Number of platelet transfusions; 7. Plasma transfusion volume.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Adults aged 18 years or older, regardless of gender;
2. Diagnosed with acute promyelocytic leukemia (APL) through bone marrow cell morphology, immunophenotype, cytogenetics and molecular biology tests, with positive PML-RARα fusion gene (including classic and variant types);
3. During induction therapy, peripheral blood white blood cell count (WBC) > 4×10^9/L, and clinical need to initiate leukopenia treatment;
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2, able to tolerate study-related treatment and examinations;
5. Expected survival time >= 3 months;
6. No severe failure of coagulation function, liver and kidney function (liver function: ALT/AST ≤ 3× upper limit of normal (ULN), total bilirubin <= 1.5×ULN; kidney function: serum creatinine <= 1.5×ULN, endogenous creatinine clearance rate >= 60 ml/min; coagulation function: no uncorrectable severe bleeding tendency);
7. Before enrollment, the study content, benefits and potential risks have been fully informed, and the subject or their legal representative voluntarily signed the written informed consent form;
8. Able to cooperate with the entire course of treatment, examination and follow-up in the study, with good compliance.

排除标准：

1.诱导治疗（双诱导）期间外周血 WBC＜4×10^9/L，或临床无需应用降白细胞药物治疗者；
2.既往确诊为其他类型恶性血液系统疾病或实体肿瘤，且近 5 年内接受过抗肿瘤治疗者；
3.对维奈克拉、传统化疗药物（羟基脲、阿糖胞苷、蒽环类等）或其辅料存在明确过敏史者；
4.入组前 4 周内接受过其他临床试验药物治疗，或同期参与其他干预性临床研究；
5.存在严重的器官功能障碍，且无法控制：（1）肝功能衰竭（ALT/AST>3×ULN，或总胆红素 > 1.5×ULN 且合并肝性脑病等并发症）；（2）肾功能衰竭（血肌酐 > 1.5×ULN，或内生肌酐清除率 < 60ml/min，或需要透析治疗）；（3）心功能不全（纽约心脏病协会（NYHA）心功能分级≥3 级，或左心室射血分数（LVEF）<50%，或存在无法控制的心律失常、严重心肌病）；（4）呼吸功能衰竭，需要机械通气支持；
6.存在活动性、无法控制的感染（如败血症、活动性结核、真菌性肺炎等），或人类免疫缺陷病毒（HIV）阳性、乙型肝炎病毒表面抗原（HBsAg）阳性且乙肝病毒 DNA 定量 > 1×10^3IU/ml、丙型肝炎病毒（HCV）RNA 阳性；
7.存在 QT 间期延长（校正 QT 间期（QTc）>470ms（女性）/450ms（男性）），或存在长 QT 综合征家族史，或正在使用明确可延长 QT 间期的药物且无法停用；
8.妊娠期、哺乳期女性，或有生育能力的男女双方在研究期间及治疗结束后 6 个月内不愿采取有效避孕措施者；
9.存在精神疾病、认知障碍，或因其他原因无法配合知情同意、治疗及随访者；研究者判断存在其他不适合入组的情况（如药物滥用史、依从性极差、家庭社会因素无法支持研究全程等）。

Exclusion criteria：

1. Patients with peripheral blood WBC < 4×10^9/L during the induction treatment (double induction), or those who do not require leukopenia drugs for clinical treatment; 2. Patients previously diagnosed with other types of malignant hematological diseases or solid tumors and who have received anti-tumor treatment within the past 5 years; 3. Patients with a clear history of allergy to venetoclax, traditional chemotherapy drugs (hydroxyurea, cytarabine, anthracyclines, etc.) or their excipients; 4. Patients who have received other clinical trial drugs within 4 weeks before enrollment or are participating in other interventional clinical studies at the same time; 5. Patients with severe organ dysfunction that cannot be controlled: (1) Liver failure (ALT/AST > 3×ULN, or total bilirubin > 1.5×ULN and accompanied by complications such as hepatic encephalopathy); (2) Renal failure (serum creatinine > 1.5×ULN, or endogenous creatinine clearance rate < 60ml/min, or requiring dialysis treatment); (3) Cardiac insufficiency (NYHA cardiac function classification >= 3, or left ventricular ejection fraction (LVEF) < 50%, or having uncontrollable arrhythmia, severe cardiomyopathy); (4) Respiratory failure requiring mechanical ventilation support; 6. Patients with active, uncontrollable infections (such as sepsis, active tuberculosis, fungal pneumonia, etc.), or those who are HIV positive, HBsAg positive with quantitative hepatitis B virus DNA > 1×10^3IU/ml, or HCV RNA positive; 7. Patients with prolonged QT interval (corrected QT interval (QTc) > 470ms (female) / 450ms (male)), or those with a family history of long QT syndrome, or those currently using drugs that are known to prolong the QT interval and cannot be discontinued; 8. Pregnant or lactating women, or men and women of childbearing age who are unwilling to take effective contraceptive measures during the study and within 6 months after treatment; 9. Patients with mental illness, cognitive impairment, or other reasons that prevent them from cooperating with informed consent, treatment, and follow-up; The investigator determines that there are other situations that make the patient unsuitable for enrollment (such as a history of drug abuse, extremely poor compliance, or family and social factors that cannot support the entire study process, etc.).

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-04 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	40
Group：	experimental group	Sample size：	40
干预措施：	维奈克拉降白细胞	干预措施代码：
Intervention：	Ven reduces white blood cells.	Intervention code：

组别：	对照组	样本量：	40
Group：	control group	Sample size：	40
干预措施：	化疗药物降白细胞	干预措施代码：
Intervention：	Chemotherapy drugs reduce white blood cells.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	临沂市人民医院	单位级别：	三级甲等
Institution hospital：	Medical facility	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	WBC下降速度及峰值控制（7天内WBC降至<4×10^9/L的比例）	指标类型：	主要指标
Outcome：	Observe the rate of WBC decline and the peak value control (the proportion of WBC dropping to < 4×10^9/L within 7 days)	Type：	Primary indicator
测量时间点：	以启动降白干预治疗当日为研究第 1 天，至第 7 天 24 时为止	测量方法：	所有患者加用降白细胞药物治疗后，每日监测血常规，观察白细胞开始下降的时间，应用降白药物时间，WBC下降速度及峰值
Measure time point of outcome：	Intervention treatment from the day of initiation until 24:00 on the 7th day	Measure method：	After all the patients were treated with drugs to reduce white blood cells, their blood counts were monitored daily to observe the time when the white blood cell count began to decrease, the duration of using the drugs to reduce white blood cells, the rate of decrease in white blood cell count, and the peak value.

指标中文名：	住院时间	指标类型：	次要指标
Outcome：	length of hospital stay	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	住院费用	指标类型：	次要指标
Outcome：	hospitalization expenses	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血小板输注次数	指标类型：	次要指标
Outcome：	Number of platelet transfusions	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：	无	组织：
Sample Name：	NA	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	18	岁 years
最大 Max age	80	岁 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）：

由独立研究人员按分层区组随机化方法生成随机数列。

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

Random number sequences were generated by independent researchers using stratified block randomization.

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：	开放标签
Blinding：	Open-label study

是否共享原始数据： IPD sharing	是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）：	本研究预计在研究结束后 12 个月内，通过中国临床试验注册中心指定的原始数据共享平台，共享去标识化的研究原始数据，供相关领域科研人员开展二次分析与研究验证使用。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	This study is expected to share the de-identified original research data through the original data sharing platform designated by the Chinese Clinical Trial Registry within 12 months after the conclusion of the research, for secondary analysis and research validation by relevant field researchers.
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：	病历记录表；电子HIS系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Medical record form; Electronic HIS system
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-04-08 17:07:19