MedDataX Logo

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

NCT ID: NCT01459887

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Rituximab, a chimeric anti-CD20 monoclonal antibody, has been proved valuable treatment for CD20-positive DLBCL. The combination of rituximab with CHOP has been shown to increase both survival and response rate, in comparison to CHOP alone. CMAB304(Retuxira), a biosimilar of rituximab, was developed by Shanghai CP Guojian Pharmaceutical Co.,Ltd. Previous Phase I study showed that CMAB304 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. In this study, efficacy and safety of CMAB304 were evaluated in DLBCL patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

combination group

Group Type EXPERIMENTAL

CHOP combined with CMAB304

Intervention Type DRUG

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.

sequential group

Group Type EXPERIMENTAL

CHOP, CMAB304

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

cyclophosphamide, doxorubicin, vincristine, prednisone cyclophosphamide, doxorubicin, vincristine, prednisone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age from 18 to 70 year, male or female
2. Previously untreated
3. DLBCL patients with CD20-positive
4. Lymphoma lesions can be Measured and evaluated; Spiral CT or MR evaluation of the lesion must be ≥ 1cm; Measured by clinical examination or others must be ≥ 2cm
5. Normal blood test, adequate liver and renal function;
6. ECOG score 0\~2
7. Life expectancy of greater than 3 months
8. No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
9. Signed ICF

Exclusion Criteria

1. DLBCL transformed from other low-grade NHL types
2. Primary central nervous system lymphoma, or primary gastrointestinal DLBCL
3. History of foreign protein allergies
4. Abnormal liver and/or renal function
5. Suspected or diagnosed central nervous system violation
6. Serious infection or organic diseases
7. Heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months
8. Breastfeeding or pregnant
9. Leukemia crisis or bone marrow metastases
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai CP Guojian Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jun Zhu, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Daobin Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Weijing Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Chinese PLA Military Academy of Medical Sciences

Yiping Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Jifeng Feng, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Cancer Institute & Hospital

Yu Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Qitao Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of Guangxi Medical University

Yuankai Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute ＆Hospital. China Academy of Medical Sciences

Lugui Qiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Hematonosis Hospital

Ting Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Wenbin Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Ping Zou, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital of Tongji Medical College of Huazhong University of Science ＆ Technology

Zhongzhen Guan, PhD

Role: STUDY_CHAIR

Sun Yat-sen University

Huiqiang Huang, PhD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SUN-YAT-SEN university cancer center

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

304NHL-050617

Identifier Type: -

Identifier Source: org_study_id