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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai CP Guojian Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01459887
First received: October 18, 2011
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Diffuse Large B Cell Lymphoma
 Drug: CHOP combined with CMAB304
Drug: CHOP, CMAB304
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai CP Guojian Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • overall response rate [ Time Frame: up to 18 weeks ] [ Designated as safety issue: Yes ]
    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:
  • event-free survival [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause.


Enrollment: 278
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: cyclophosphamide, doxorubicin, vincristine, prednisone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459887

Locations
China, Guangdong
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
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 Provincial Cancer Hospital
Principal Investigator: Qitao Yu, PhD 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
  More Information

No publications provided

Responsible Party: Shanghai CP Guojian Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01459887     History of Changes
Other Study ID Numbers: 304NHL-050617
Study First Received: October 18, 2011
Last Updated: October 25, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai CP Guojian Pharmaceutical Co.,Ltd.:
untreated, CD20-positive

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013