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

NCT01459887 | Completed Phase 3 DMC

• 1 other identifier: 304NHL-050617
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

untreated, CD20-positive

Outcome Measures

Primary Outcomes (1)

• overall response rate

  Tumor responses were assessed after 6 cycles of CMAB304-CHOP or 6 cycles of CHOP alone and classified as CR,CRu,PR,SD or PD.

  up to 18 weeks

Secondary Outcomes (1)

• event-free survival

  From date of randomization until the date of first documented progression or relapse, institution of a new anticancer treatment, or death from any cause, whichever came first, assessed up to 50 months

Study Arms (2)

combination group

EXPERIMENTAL

Drug: CHOP combined with CMAB304

sequential group

EXPERIMENTAL

Drug: CHOP, CMAB304

Interventions

CHOP combined with CMAB304 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.

Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone

combination group

CHOP, CMAB304 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.

Also known as: cyclophosphamide, doxorubicin, vincristine, prednisone

sequential group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 year, male or female
• Previously untreated
• DLBCL patients with CD20-positive
• 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
• Normal blood test, adequate liver and renal function;
• ECOG score 0\~2
• Life expectancy of greater than 3 months
• No other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer
• Signed ICF

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai CP Guojian Pharmaceutical Co., Ltd.: lead

Study Sites (1)

SUN-YAT-SEN university cancer center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Jun Zhu, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

• Daobin Zhou, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Weijing Zhang, PhD

  Affiliated Hospital of Chinese PLA Military Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Yiping Zhang, PhD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Jifeng Feng, PhD

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

• Yu Yang, PhD

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Qitao Yu, PhD

  Cancer Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

• Yuankai Shi, PhD

  Cancer Institute ＆Hospital. China Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Lugui Qiu, PhD

  Tianjin Hematonosis Hospital

  PRINCIPAL INVESTIGATOR

• Ting Liu, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Wenbin Qian, PhD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Ping Zou, PhD

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

  PRINCIPAL INVESTIGATOR

• Zhongzhen Guan, PhD

  Sun Yat-sen University

  STUDY CHAIR

• Huiqiang Huang, PhD

  Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

CN (1)