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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
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.
up to 18 weeks
Jun Zhu, PhD
Peking University Cancer Hospital
China: Food and Drug Administration