NCT01459887

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Shanghai CP Guojian Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2011-10-26
• Last updated: 2011-10-26

Locations

1 site across 1 country: China