Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma

Summary

CD20, the protein which is expressed on the surface of all mature B cells, is active in many B-cell lymphomas that express this molecule such as Diffuse Large B Cell Lymphoma (DLBCL), the most frequently occurring subtype of non-Hodgkin lymphomas. In clinical practice, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone combination chemotherapy (CHOP) is still considered one of the standard treatment to DLBCL. CMAB304(Retuxira), the chimeric monoclonal antibody is designed to targeted against CD20 for treatment of lymphoma diseases. This trial aimed to observe the safety and efficacy of CMAB304, by added CMAB304 to CHOP chemotherapy regimen compared with CHOP chemotherapy alone.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

DRUG

CHOP combined with CMAB304

Patients treated with CHOP-304 undergo 1 cycle every 3 weeks, received CMAB304 at a dose of 375 mg/m2 on day 1 and CHOP on day 2 of each of the 6 cycles.

DRUG

CHOP, CMAB304

First standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles.

Sponsors & Collaborators

• Shanghai CP Guojian Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Jun Zhu, PhD · Peking University Cancer Hospital & Institute

• Daobin Zhou, PhD · Peking Union Medical College Hospital

• Weijing Zhang, PhD · Affiliated Hospital of Chinese PLA Military Academy of Medical Sciences

• Yiping Zhang, PhD · Zhejiang Cancer Hospital

• Jifeng Feng, PhD · Jiangsu Cancer Institute & Hospital

• Yu Yang, PhD · Fujian Cancer Hospital

• Qitao Yu, PhD · Cancer Hospital of Guangxi Medical University

• Yuankai Shi, PhD · Cancer Institute ＆Hospital. China Academy of Medical Sciences

• Lugui Qiu, PhD · Tianjin Hematonosis Hospital

• Ting Liu, PhD · West China Hospital

• Wenbin Qian, PhD · First Affiliated Hospital of Zhejiang University

• Ping Zou, PhD · Union Hospital of Tongji Medical College of Huazhong University of Science ＆ Technology

• Zhongzhen Guan, PhD · Sun Yat-sen University

• Huiqiang Huang, PhD · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-09-30

Primary Completion

2010-12-31

Completion

2011-02-28

Countries

• China

Study Locations