Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)
NCT ID: NCT03777085
Last Updated: 2019-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
230 participants
INTERVENTIONAL
2019-01-10
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TQB2303
TQB2303
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
Rituximab
Rituximab
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
Interventions
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TQB2303
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
Rituximab
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. 18 years to 75 years; Male or female patients.
3. International Prognostic Index (IPI) score of 0 to 2.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. More than 6 months life expectancy judged by the researchers.
6. At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis.
7. left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
8. Adequate hematologic function, no matter the bone marrow was attacked or not, as follows:absolute neutrophil count (ANC) ≥1.5×10\^9/L and platelet count≥75×\^9/L.
9. Understood and Signed an informed consent form.
Exclusion Criteria
2. Known allergic reactions against any component of CHOP regimen.
3. Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
4. T-cell/histiocyte-rich large B-cell lymphoma, Primary DLBCL of the CNS, Primary cutaneous DLBCL, leg type, EBV-positive DLBCL of the elderly (EBV + DLBCL), EBV-positive DLBCL of the elderly (EBV + DLBCL), DLBCL associated with chronic infammation, Lymphomatoid granulomatosis, Primary mediastinal (thymic) large B-cell lymphoma (PMBL), ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, ALK-positive large B-cell lymphoma, high-grade B-cell lymphoma (high-grade B-cell lymphoma with MYC, with or without concurrent in BCL2 and/or BCL6 gene rearrangements, high-grade B-cell lymphoma, NOS), B-cell lymphoma, Not categorizable, Characteristics between DLBCL and classical Hodgkin's lymphoma, transformed DLBCL, DLBCL secondary central nervous system invasion;
5. Other malignant tumors that have been or are currently suffering (healed skin basal cell carcinoma or cutaneous squamous cell carcinoma, or cutaneous melanoma or cervical carcinoma in situ).
6. Significantly poorly controlled diseases that can affect adherence to the study protocol, such as severe cardiovascular disease (such as the New York Heart Association class III or IV heart disease, myocardial infarction or unstable arrhythmia in the last 6 months or Unstable angina, severe hypertension, peripheral nervous system or central nervous system disease;
7. Patients with a history of progressive multifocal leukoencephalopathy.
8. Continuous corticosteroid treatment being received, dose \>30 mg/day prednisone or equivalent dose of corticosteroids ≥10 days.
9. Participation in another interventional clinical trial in the past 3 months.
10. Patients who received or underwent major surgeries within 28 days prior to enrollment, or patients with unsurgical wounds.
11. Treated with transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to enrollment.
12. Vaccination within 28 days or planned prior to enrollment.
13. Appearing the following laboratory abnormal values.
1. Coagulation function: partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) or international normalized ratio (INR) \> 1.5 times ULN without anticoagulant therapy.
2. Liver function: total bilirubin (TBIL) \> 1.5 times the upper limit of normal (3 times the upper limit of normal value when the liver is invaded), alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal value (\>5 times the upper limit of normal value when the liver is invaded)
3. Renal function: serum creatinine (Cr) \> 1.5 times the upper limit of normal value.
14. an active infection at the time of enrollment, or any major infection events that affected the enrollment of the subjects determined by the investigator within 28 days (except for neoplastic fever).
15. Suspected active or latent tuberculosis infections.
16. HBsAg positive and/or HBcAb positive and HBV DNA positive.
17. HCV antibody and HCV-RNA positive; or HIV positive patients.
18. Pregnancy or breast feeding. Companion for women of childbearing age or women of childbearing age,who reluctant to take appropriate contraceptive methods within one year after the last treatment of the study;Pregnancy before pregnancy screening, the women who blood / urine results were positive.
19. Patients that researchers deem as not appropriate to enter the study.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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No.150 Haping Road, Nangang District
Haerbin, Heilongjiang, China
No. 42 Baiziting Road, Xuanwu District
Nanjing, Jiangsu, China
No.8 Jiangtan Road,Weibin District
Baoji, , China
No. 87 Xiangya Road Furong District
Changsha, , China
No.138 Tongzipo Road Yuelu District
Changsha, , China
No.139 Renmin Middle Road Furong District
Changsha, , China
No. 37 Guoxue Lane Wuhou District
Chengdu, , China
No. 55 Section 4 Renmin South Road Wuhou District
Chengdu, , China
No. 10 Daping Yangtze River Branch Road Yuzhong District
Chongqing, , China
No.183 Xinqiao Main Street Shapingba District
Chongqing, , China
No.420 Fuma Road, Jin'an district
Fuzhou, , China
No.295 Xichang Road, Wuhua District
Kunming, , China
No. 701 Donggang Road (West) Chengguan District
Lanzhou, , China
No. 82 Cuiyingmen Chengguan District
Lanzhou, , China
No.333 Nanbinhe Middle Road Qilihe District
Lanzhou, , China
No. 8 Wenchang Road Chengzhong District
Liuzhou, , China
No.519 Beijing East Road High - tech District
Nanchang, , China
No.71 Embankment Road, Qingxiu District
Nanning, , China
No.20 Xisi Road Chongchuan District
Nantong, , China
No.1677 Wutai Mountain Road Huangdao District
Qingdao, , China
No 137 Carp mountain Road New district
Ürümqi, , China
No. 151 Guangwen Street Kuiwen District
Weifang, , China
No. 3, West Mt. East Road, Wendeng District, Weihai City
Weihai, , China
No. 1277 Jiefang Avenue Jianghan District
Wuhan, , China
No.31 Hygienic Lane Haizang Road Liangzhou District
Wuwei, , China
No. 15 West ChangLe Road New City District
Xi'an, , China
No.256 Youyi West Road Beilin District
Xi'an, , China
No. 7 Weiwu Road Jinshui District
Zhengzhou, , China
No.1 Jianshe East Road Erqi District
Zhengzhou, , China
No.127 Dongming Road, Jinshuii District
Zhengzhou, , China
No. 54 Communist Youth League Road Zhangdian District
Zibo, , China
Countries
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Facility Contacts
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Qingyuan Zhang, Doctor
Role: primary
Jifeng Feng, doctor
Role: primary
Yazhou Yao, Doctor
Role: primary
Xielan Zhao
Role: primary
Peiguo Cao
Role: primary
Chunhong Hu
Role: primary
Yuping Gong
Role: primary
Zhihui Zhang
Role: primary
Dong Wang
Role: primary
Yao Liu
Role: primary
Yu Yang, Doctor
Role: primary
Yun Zeng
Role: primary
Yaming Xi
Role: primary
Chongyang Wu
Role: primary
Hai Bai
Role: primary
Jinxiong Huang
Role: primary
Yuerong Shuang
Role: primary
Hong Cen, Doctor
Role: primary
Hong Liu
Role: primary
Hongwei Xue
Role: primary
Xinhong Guo
Role: primary
Xuehong Ran
Role: primary
Binghua Wang
Role: primary
Liling Zhang
Role: primary
Youquan Dang, Doctor
Role: primary
Guangxun Gao
Role: primary
Yi Wang
Role: primary
Zunmin Zhu
Role: primary
Mingzhi Zhang
Role: primary
Yufu Li, Doctor
Role: primary
Zhencheng Wang
Role: primary
Other Identifiers
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TQB2303-III-01
Identifier Type: -
Identifier Source: org_study_id
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