Study of TQB2303 in Patients With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777085
• Other study ID #: TQB2303-III-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• TQB2303
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
• Rituximab
375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks

Locations

Country	Name	City	State
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.150 Haping Road, Nangang District	Haerbin	Heilongjiang
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. 42 Baiziting Road, Xuanwu District	Nanjing	Jiangsu
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. 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 137 Carp mountain Road New district	Wulumuqi
China	No.31 Hygienic Lane Haizang Road Liangzhou District	Wuwei
China	No. 15 West ChangLe Road New City District	Xian
China	No.256 Youyi West Road Beilin District	Xian
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

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)		18 weeks
Secondary	Objective Response Rate (CR+CRu)		18 weeks
Secondary	Progression-free survival (PFS)		18 weeks
Secondary	Event-free survival (EFS)		18 weeks
Secondary	Duration of Response (DOR)		18 weeks
Secondary	:Overall survival (OS)		18 weeks