Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)
Multicenter, Randomized, Double-blind, Parallel Controlled, Phase III Clinical Study to Compare the Efficacy and Safety of TQB2303 in Conbination With CHOP Regimen (T-CHOP) Versus Rituximab in Combination With CHOP Regimen (R-CHOP) in Previously Untreated Subjects With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)
1 other identifier
interventional
230
1 country
31
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2019
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedStudy Start
First participant enrolled
January 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedMay 30, 2019
May 1, 2019
2 years
December 13, 2018
May 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
18 weeks
Secondary Outcomes (5)
Objective Response Rate (CR+CRu)
18 weeks
Progression-free survival (PFS)
18 weeks
Event-free survival (EFS)
18 weeks
Duration of Response (DOR)
18 weeks
:Overall survival (OS)
18 weeks
Study Arms (2)
TQB2303
EXPERIMENTALRituximab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Untreated CD20-positive DLBCL patients confirmed by histopathology or cytology.
- years to 75 years; Male or female patients.
- International Prognostic Index (IPI) score of 0 to 2.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- More than 6 months life expectancy judged by the researchers.
- 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.
- left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography greater than or equal to 50%.
- 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.
- Understood and Signed an informed consent form.
You may not qualify if:
- 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.
- Coagulation function: partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) or international normalized ratio (INR) \> 1.5 times ULN without anticoagulant therapy.
- 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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
No.150 Haping Road, Nangang District
Haerbin, Heilongjiang, 150000, 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
Liuchow, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 17, 2018
Study Start
January 10, 2019
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
May 30, 2019
Record last verified: 2019-05