drugset
drugset / Trial / NCT01459887

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

NCT01459887 ↗

Phase 3 Completed 278 enrolled Shanghai CP Guojian Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2006-09
Primary completion
2010-12
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject CMAB304 Monoclonal antibody 375 mg/m2 —
Background Cyclophosphamide Other / unclassified — —
Background Doxorubicin Other / unclassified — —
Background Prednisone Other / unclassified — —
Background Vincristine Small molecule — —

Indications

diffuse large B-cell lymphoma