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The Purpose of This Study is to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics between TQB2303 and Rituximab in Combination With CHOP in Previously Untreated Patients with Diffuse Large B-cell Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2303 | Experimental |
| |
| Rituximab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2303 | Drug | 375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (CR+CRu) | 18 weeks | |
| Progression-free survival (PFS) | 18 weeks | |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
Known allergic reactions against any component of CHOP regimen.
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.
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;
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).
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;
Patients with a history of progressive multifocal leukoencephalopathy.
Continuous corticosteroid treatment being received, dose >30 mg/day prednisone or equivalent dose of corticosteroids ≥10 days.
Participation in another interventional clinical trial in the past 3 months.
Patients who received or underwent major surgeries within 28 days prior to enrollment, or patients with unsurgical wounds.
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.
Vaccination within 28 days or planned prior to enrollment.
Appearing the following laboratory abnormal values.
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).
Suspected active or latent tuberculosis infections.
HBsAg positive and/or HBcAb positive and HBV DNA positive.
HCV antibody and HCV-RNA positive; or HIV positive patients.
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.
Patients that researchers deem as not appropriate to enter the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.150 Haping Road, Nangang District | Recruiting | Haerbin | Heilongjiang | 150000 | China |
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| Rituximab |
| Drug |
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks |
|
| 18 weeks |
| Duration of Response (DOR) | 18 weeks |
| :Overall survival (OS) | 18 weeks |
| No. 42 Baiziting Road, Xuanwu District | Recruiting | Nanjing | Jiangsu | China |
|
| No.8 Jiangtan Road,Weibin District | Recruiting | Baoji | China |
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| No. 87 Xiangya Road Furong District | Not yet recruiting | Changsha | China |
|
| No.138 Tongzipo Road Yuelu District | Recruiting | Changsha | China |
|
| No.139 Renmin Middle Road Furong District | Recruiting | Changsha | China |
|
| No. 37 Guoxue Lane Wuhou District | Not yet recruiting | Chengdu | China |
|
| No. 55 Section 4 Renmin South Road Wuhou District | Recruiting | Chengdu | China |
|
| No. 10 Daping Yangtze River Branch Road Yuzhong District | Recruiting | Chongqing | China |
|
| No.183 Xinqiao Main Street Shapingba District | Recruiting | Chongqing | China |
|
| No.420 Fuma Road, Jin'an district | Not yet recruiting | Fuzhou | China |
|
| No.295 Xichang Road, Wuhua District | Recruiting | Kunming | China |
|
| No. 701 Donggang Road (West) Chengguan District | Recruiting | Lanzhou | China |
|
| No. 82 Cuiyingmen Chengguan District | Recruiting | Lanzhou | China |
|
| No.333 Nanbinhe Middle Road Qilihe District | Recruiting | Lanzhou | China |
|
| No. 8 Wenchang Road Chengzhong District | Recruiting | Liuzhou | China |
|
| No.519 Beijing East Road High - tech District | Recruiting | Nanchang | China |
|
| No.71 Embankment Road, Qingxiu District | Recruiting | Nanning | China |
|
| No.20 Xisi Road Chongchuan District | Recruiting | Nantong | China |
|
| No.1677 Wutai Mountain Road Huangdao District | Not yet recruiting | Qingdao | China |
|
| No 137 Carp mountain Road New district | Recruiting | Ürümqi | China |
|
| No. 151 Guangwen Street Kuiwen District | Recruiting | Weifang | China |
|
| No. 3, West Mt. East Road, Wendeng District, Weihai City | Recruiting | Weihai | China |
|
| No. 1277 Jiefang Avenue Jianghan District | Recruiting | Wuhan | China |
|
| No.31 Hygienic Lane Haizang Road Liangzhou District | Recruiting | Wuwei | China |
|
| No. 15 West ChangLe Road New City District | Recruiting | Xi'an | China |
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| No.256 Youyi West Road Beilin District | Not yet recruiting | Xi'an | China |
|
| No. 7 Weiwu Road Jinshui District | Recruiting | Zhengzhou | China |
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| No.1 Jianshe East Road Erqi District | Not yet recruiting | Zhengzhou | China |
|
| No.127 Dongming Road, Jinshuii District | Recruiting | Zhengzhou | China |
|
| No. 54 Communist Youth League Road Zhangdian District | Recruiting | Zibo | China |
|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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