Today is 2019-12-12

A Phase II Randomized Controlled Trial for Lenalidomide as Maintenance Therapy Following Standard Chemotherapy for Patients with High-intermediate/ High risk invasive B-cell lymphoma
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注册号:

Registration number:

ChiCTR1900021789 

最近更新日期:

Date of Last Refreshed on:

2019-03-10 

注册时间:

Date of Registration:

2019-03-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中-高/高危风险侵袭性B细胞淋巴瘤一线化疗后来那度胺单药维持治疗的Ⅱ期临床研究 

Public title:

A Phase II Randomized Controlled Trial for Lenalidomide as Maintenance Therapy Following Standard Chemotherapy for Patients with High-intermediate/ High risk invasive B-cell lymphoma  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中-高/高危风险侵袭性B细胞淋巴瘤一线化疗后来那度胺单药维持治疗的Ⅱ期临床研究 

Scientific title:

A Phase II Randomized Controlled Trial for Lenalidomide as Maintenance Therapy Following Standard Chemotherapy for Patients with High-intermediate/ High risk invasive B-cell lymphoma  

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:

付淳曦 

研究负责人:

邹立群 

Applicant:

FU CHUNXI 

Study leader:

ZOU LIQUN 

申请注册联系人电话:

Applicant telephone:

+86 18782068458 

研究负责人电话:

Study leader's telephone:

+86 18980601027 

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:

fcx0201@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hxlcyxy@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:

成都市武侯区国学巷37号四川大学华西医院 

研究负责人通讯地址:

成都市武侯区国学巷37号四川大学华西医院 

Applicant address:

37 Guoxue Road, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Road, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院肿瘤一科 

Primary sponsor:

Department One of Oncology, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Road, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Road, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

Nil 

Source(s) of funding:

Nil 

研究疾病:

侵袭性B细胞淋巴瘤 

Target disease:

Invasive B cell lymphoma 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

II期临床试验 

Study phase:

研究目的:

评价中-高/高危风险侵袭性B细胞淋巴瘤患者一线化疗后来那度胺单药维持治疗的疗效和安全性 

Objectives of Study:

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

入组患者须满足以下标准: 1、年龄大于18岁; 2、根据WHO 2016诊断标准,组织病理确诊为CD20(+)的弥漫大B细胞淋巴瘤(DLBCL)、从低级别淋巴瘤(滤泡性或其他)中转化的DLBCL、与骨髓中的小细胞浸润相关的DLBCL、高增殖活性的侵袭性B细胞淋巴瘤、原发中枢的弥漫大B细胞淋巴瘤。 3、基线IPI评分为中高危及高危( 年龄>60岁:IPI ≥3 ,年龄≤60岁:aaIPI ≥2); 4、患者一线化疗后接受或未接受过放射治疗,疗效评价为PR或CR(确认或未确认),年龄<60岁拒绝行造血干细胞移植,或年龄≥60岁者; 4、患者既往仅接受过一种化疗方案; 注: 一线治疗方案需包含蒽环类的联合化疗,如CHOP; 自体干细胞移植支持下大剂量化疗算为一种治疗方案; 疗法定义为新的治疗组合或药物,从CVP到CHOP的变化属于新疗法,再次使用同样疗法或药物治疗时不属于新疗法; 5、ECOG评分为0-2; 6、主要器官功能在治疗前7天内,符合下列标准: - 血常规检查标准(14天内未输血状态下): ?血红蛋白(HB)≥80g/L; ?中性粒细胞绝对值(ANC)≥1.0×109/L; ?血小板(PLT)≥50×109/L; - 生化检查需符合以下标准: ?总胆红素(TBIL)≤1.5倍正常值上限(ULN); ?丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶AST≤2.5ULN,如伴肝脏受累,则ALT和AST≤5ULN — 心脏多普勒超声评估:左室射血分数(LVEF)≥正常值低限 (50%); 7、育龄期男性和女性在整个研究期间及研究治疗结束后4周内同意采取可靠的避孕手段; 8、患者自愿参加本次研究,签署知情同意书。 

Inclusion criteria

1. Aged ≥ 18 years old; 2. According to the 2016 revision of the World Health Organization(WHO) classification of lymphoid neoplasms, histopathologically confirmed diffuse large B-cell lymphoma (DLBCL) with CD20(+), DLBCL transformed from low-grade lymphoma (follicular or other), DLBCL associated with small cell infiltration in the bone marrow, invasive B-cell lymphoma with high proliferative activity(High-grade B-cell lymphoma(NOS) or High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements), Primary DLBCL of the central nervous system (CNS); 3. Baseline IPI scores were classified to high risk or High-intermediate risk (age > 60 years: IPI ≥ 3, age ≤ 60 years: aaIPI ≥ 2); 4. Patients received radiation therapy after first-line chemotherapy or not, and the efficacy was evaluated as PR or CR (confirmed or unconfirmed), and age <60 years old who refused to perform hematopoietic stem cell transplantation, or age ≥ 60 years old; 5. The patient has only received only one chemotherapy regimen in the past; Note: (1) The first-line treatment plan needs to include an anthracycline-based chemotherapy, such as CHOP; (2) High-dose chemotherapy supported by autologous stem cell transplantation is considered as a treatment plan; (3) Therapy is defined as a new regimen such as the diversification from CVP to CHOP , and it is not defined as a new treatment when the same treatment or medication is used again; 6. ECOG≤2分; 7. The main organ function meets the following criteria within 7 days prior to treatment: (1) Blood routine examination criteria (without blood transfusion within 14 days): Hemoglobin (HB) ≥ 80g/L; The absolute value of neutrophils (ANC) ≥ 1.0×10^9/L; platelets (PLT) ≥ 50×10^9/L; (2) Biochemical tests are subject to the following criteria: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase AST≤2.5ULN, or ALT and AST ≤ 5ULN if liver involvement; (3) Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%). 8. Men and women of childbearing age agreed to adopt reliable contraceptive methods during the entire study period and within 4 weeks after the end of study treatment; 9. Patients volunteered to participate in the study and signed informed consent. 

排除标准:

若患者符合以下任一标准,则不能入组: 1.患者既往接受过沙利度胺或来那度胺治疗; 2.除纳入标准外的其他类型淋巴瘤; 3.患者除了目标肿瘤以外患有或过去5年内曾患有一种活动性恶性肿瘤; 4.由于之前任何药物给药导致的临床意义非血液学不良事件仍未恢复(达到CTCAE毒性3级),不包括脱发和长春碱类引起的≤2级的神经毒性; 5.患者正接受治疗剂量的系统性类固醇治疗,允许使用最高为10mg/天的低剂量类固醇[地塞米松或等同物]治疗非肿瘤性疾病; 6.先前治疗接受过阿霉素或相当于450mg/m2累积剂量的患者,计算公式:[(X/450+Y/160)>1],其中X表示mg/ m2阿霉素的剂量,Y表示mg/m2米托蒽醌的剂量; 7.患者在入组前4周内使用了其他研究性药物进行治疗; 8.患者为孕妇或哺乳期妇女(任何在研究期间怀孕的女性都要立即退出该研究); 9.患者出现严重感染、医疗状况或精神状况,研究者认为该状况可能干扰研究目的的达成; 10.已知患有人类免疫缺陷病毒(HIV)、活动性肝炎; 11.临床上显著的心血管异常(纽约心脏病协会(NYHA)分级:III/IV)、入组前6个月内发生过心肌梗塞、恶性心率失常(包括QTC≥480ms)、使用降压药物血压仍控制不理想(收缩压≥150 mmHg,舒张压≥100 mmHg)患者、未能控制的心绞痛; 12.具有精神类药物滥用史且无法戒除或有精神障碍者; 13.对本品活性成分或其中任何辅料严重过敏者; 14.根据研究者的判断,有严重危害患者安全或影响患者完成研究的伴随疾病者。 

Exclusion criteria:

1. The patient has previously received thalidomide or lenalidomide treatment; 2. Other types of lymphoma; 3. The patient is diagnosed another active malignancy in addition to the target tumor now or within the past 5 years. 4. The clinically significant non-hematologic adverse events caused by any previous drug have not recovered (to reach CTCAE toxicity level 3), excluding alopecia and neurotoxicity induced by vincaalkaloid which ≤ level 2; 5. The patient is receiving a therapeutic dose of systemic steroid therapy, allowing the use of low-dose steroids [dexamethasone or equivalent] up to 10 mg/day for non-neoplastic disease; 6. Patients who received doxorubicin with a cumulative dose equivalent to 450 mg/m2, calculated as: [(X/450+Y/160)>1] in previous treatment, where X represents the dose of mg/m2 doxorubicin and Y represents mg Dosage of /m2 mitoxantrone; 7. The patient was treated with other research drugs within 4 weeks prior to enrollment; 8. The patient is pregnant or lactating (any woman who is pregnant during the study will withdraw from the study immediately); 9. The patient has a serious infection, a clinically significant disease, or a mental illness. The investigator believes that the condition may interfere with the achievement of the research purpose; 10. Patient was diagnosed with human immunodeficiency virus (HIV) or active hepatitis; 11. Clinically significant cardiovascular abnormalities (New York Heart Association (NYHA) classification: III/IV), myocardial infarction within 6 months prior to enrollment, malignant arrhythmia (including QTC ≥ 480ms), blood pressure unsatisfactory control when using antihypertensive drugs(systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg), uncontrolled angina; 12. Patients with a history of psychotropic substance abuse who is unable to quit or has a mental disorder; 13. Those who are severely allergic to the active ingredients of this product or any of its excipients; 14. According to the investigator's judgment, there are patients with severe disease that are harmful to the safety of the patient or affect the patient's completion of the study.  

研究实施时间:

Study execute time:

From2019-03-01To 2021-03-01 

干预措施:

Interventions:

组别:

实验组

样本量:

150

Group:

Experimental group

Sample size:

干预措施:

来那度胺维持治疗25mg,qd,po,d1-21

干预措施代码:

Intervention:

Lenalidomide as Maintenance Therapy, 25mg, qd, po, d1-21

Intervention code:

组别:

对照组

样本量:

150

Group:

Control group

Sample size:

干预措施:

空白

干预措施代码:

Intervention:

Blank

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

china 

Province:

siichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

west china hospital sichuan university  

Level of the institution:

Third-class A 

测量指标:

Outcomes:

指标中文名:

无进展生存期

指标类型:

主要指标 

Outcome:

Progression free survival (PFS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总生存期

指标类型:

次要指标 

Outcome:

overall survival (OS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓解率

指标类型:

次要指标 

Outcome:

the rate of respose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

毒性

指标类型:

次要指标 

Outcome:

toxity

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:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

大便

组织:

Sample Name:

stool

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 years
最大 Max age 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

未说明

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

Not stated

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:

未说明

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-09
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