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

Sponsor
Shanghai CP Guojian Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01459887
Collaborator
(none)
278
Enrollment
1
Location
2
Arms
53
Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CHOP combined with CMAB304
  • Drug: CHOP, CMAB304
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
278 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-labeled, Multi-center, Randomized, Prospective Phase III Study Comparing CMAB304 in Combination With CHOP to CHOP Alone With CMAB304 Maintenance in Patients With DLBCL
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: combination group

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.
Other Names:
  • cyclophosphamide, doxorubicin, vincristine, prednisone

    		•
    Experimental: sequential group

    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.
    Other Names:
  • cyclophosphamide, doxorubicin, vincristine, prednisone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall response rate [up to 18 weeks]

      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.

    Secondary Outcome Measures

    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]

      Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SUN-YAT-SEN university cancer center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Shanghai CP Guojian Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: 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
    • Study Chair: Zhongzhen Guan, PhD, Sun Yat-sen University
    • Study Director: Huiqiang Huang, PhD, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai CP Guojian Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01459887
    Other Study ID Numbers:
    • 304NHL-050617
    First Posted:
    Oct 26, 2011
    Last Update Posted:
    Oct 26, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Shanghai CP Guojian Pharmaceutical Co., Ltd.
    untreated, CD20-positive
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Large B-Cell, Diffuse
    Prednisone
    Cyclophosphamide
    Doxorubicin
    Liposomal doxorubicin
    Vincristine

    Study Results

    No Results Posted as of Oct 26, 2011