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)

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

Study Overview

• Status: Unknown
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: TQB2303; Drug: Rituximab

• Study Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Baoji, China
    • Recruiting
    • No.8 Jiangtan Road,Weibin District
    • Contact: Yazhou Yao, Doctor; Phone Number: 0917-3390942
  • Changsha, China
    • Not yet recruiting
    • No. 87 Xiangya Road Furong District
  • Changsha, China
    • Recruiting
    • No.138 Tongzipo Road Yuelu District
    • Contact: Peiguo Cao; Phone Number: 0731-88618285
  • Changsha, China
    • Recruiting
    • No.139 Renmin Middle Road Furong District
    • Contact: Chunhong Hu; Phone Number: 0731-85295929
  • Chengdu, China
    • Not yet recruiting
    • No. 37 Guoxue Lane Wuhou District
    • Contact: Yuping Gong
  • Chengdu, China
    • Recruiting
    • No. 55 Section 4 Renmin South Road Wuhou District
    • Contact: Zhihui Zhang; Phone Number: 028-85420057
  • Chongqing, China
    • Recruiting
    • No. 10 Daping Yangtze River Branch Road Yuzhong District
    • Contact: Dong Wang; Phone Number: 023-68757150
  • Chongqing, China
    • Recruiting
    • No.183 Xinqiao Main Street Shapingba District
    • Contact: Yao Liu; Phone Number: 023-68774309
  • Fuzhou, China
    • Not yet recruiting
    • No.420 Fuma Road, Jin'an district
  • Kunming, China
    • Recruiting
    • No.295 Xichang Road, Wuhua District
    • Contact: Yun Zeng; Phone Number: 0871-65324888-2522
  • Lanzhou, China
    • Recruiting
    • No. 701 Donggang Road (West) Chengguan District
    • Contact: Yaming Xi; Phone Number: 0931-8356912
  • Lanzhou, China
    • Recruiting
    • No. 82 Cuiyingmen Chengguan District
    • Contact: Chongyang Wu; Phone Number: 0931-8943196
  • Lanzhou, China
    • Recruiting
    • No.333 Nanbinhe Middle Road Qilihe District
    • Contact: Hai Bai; Phone Number: 0931-8995099
  • Liuzhou, China
    • Recruiting
    • No. 8 Wenchang Road Chengzhong District
    • Contact: Jinxiong Huang; Phone Number: 0772-2662805
  • Nanchang, China
    • Recruiting
    • No.519 Beijing East Road High - tech District
    • Contact: Yuerong Shuang; Phone Number: 0791-88329441
  • Nanning, China
    • Recruiting
    • No.71 Embankment Road, Qingxiu District
    • Contact: Hong Cen, Doctor; Phone Number: 0771-5390813
  • Nantong, China
    • Recruiting
    • No.20 Xisi Road Chongchuan District
    • Contact: Hong Liu; Phone Number: 0513-81160502
  • Qingdao, China
    • Not yet recruiting
    • No.1677 Wutai Mountain Road Huangdao District
    • Contact: Hongwei Xue; Phone Number: 0532-82919699
  • Weifang, China
    • Recruiting
    • No. 151 Guangwen Street Kuiwen District
    • Contact: Xuehong Ran; Phone Number: 0536-8192116
  • Weihai, China
    • Recruiting
    • No. 3, West Mt. East Road, Wendeng District, Weihai City
    • Contact: Binghua Wang; Phone Number: 0631-3793349
  • Wuhan, China
    • Recruiting
    • No. 1277 Jiefang Avenue Jianghan District
    • Contact: Liling Zhang; Phone Number: 0278-5872257
  • Wulumuqi, China
    • Recruiting
    • No 137 Carp mountain Road New district
    • Contact: Xinhong Guo; Phone Number: 0991-4361350
  • Wuwei, China
    • Recruiting
    • No.31 Hygienic Lane Haizang Road Liangzhou District
    • Contact: Youquan Dang, Doctor; Phone Number: 0935-2268046
    • Principal Investigator: Cong Wang, Doctor
  • Xian, China
    • Recruiting
    • No. 15 West ChangLe Road New City District
    • Contact: Guangxun Gao; Phone Number: 029-84775202
  • Xian, China
    • Not yet recruiting
    • No.256 Youyi West Road Beilin District
  • Zhengzhou, China
    • Recruiting
    • No. 7 Weiwu Road Jinshui District
    • Contact: Zunmin Zhu; Phone Number: 0371-65896920
  • Zhengzhou, China
    • Not yet recruiting
    • No.1 Jianshe East Road Erqi District
  • Zhengzhou, China
    • Recruiting
    • No.127 Dongming Road, Jinshuii District
    • Contact: Yufu Li, Doctor; Phone Number: 0371-65587306
  • Zibo, China
    • Recruiting
    • No. 54 Communist Youth League Road Zhangdian District
    • Contact: Zhencheng Wang; Phone Number: 0533-2360985
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150000
      • Recruiting
      • No.150 Haping Road, Nangang District
      • Contact: Qingyuan Zhang, Doctor; Phone Number: 0451-86298681
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • No. 42 Baiziting Road, Xuanwu District
      • Contact: Jifeng Feng, doctor; Phone Number: 025-83284615

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Untreated CD20-positive DLBCL patients confirmed by histopathology or cytology.
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:

1. Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Rituximab	Drug: Rituximab; 375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
EXPERIMENTAL: TQB2303	Drug: TQB2303; 375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate (ORR)	18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: TQB2303-III-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No