Clinical trial NCT01459887: Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diffuse Large B Cell Lymphoma
Keywords: untreated, CD20-positive
Lead sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: overall response rate
timeFrame: up to 18 weeks
Secondary outcomes:
measure: event-free survival
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN-YAT-SEN university cancer center
state: Guangdong
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Daobin Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Chinese PLA Military Academy of Medical Sciences
name: Weijing Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: Yiping Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Cancer Institute & Hospital
name: Jifeng Feng, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujian Cancer Hospital
name: Yu Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Hospital of Guangxi Medical University
name: Qitao Yu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute ＆Hospital. China Academy of Medical Sciences
name: Yuankai Shi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Hematonosis Hospital
name: Lugui Qiu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Ting Liu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University
name: Wenbin Qian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science ＆ Technology
name: Ping Zou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Zhongzhen Guan, PhD
role: STUDY_CHAIR
affiliation: Sun Yat-sen University
name: Huiqiang Huang, PhD
role: STUDY_DIRECTOR
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