Status:
COMPLETED
Study of Recombinant Human-Mouse Chimeric Anti-CD20 Monoclonal Antibody to Treat Non-hodgkin's Lymphoma
Lead Sponsor:
Shanghai CP Guojian Pharmaceutical Co., Ltd.
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 frequen...
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 res...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT01459887
Start Date
September 1 2006
End Date
February 1 2011
Last Update
October 26 2011
Active Locations (1)
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1
SUN-YAT-SEN university cancer center
Guangzhou, Guangdong, China, 510060