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Control group A was treated with single R-CHOP protocol\[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: \<4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5\], 21 d as a cycle, for 4～6 cycles.

Trial group A was treated with Cinobufacini Tablets combined with R-CHOP protocol\[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: \<4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡d1 plus prednisone tablets 100 mg, d1～5\], 21 d as a cycle, for 4～6 cycles.

Control group B was treated with single CHOP protocol\[vindesine 3 mg/㎡ (maximum dosage: \<4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5\], 21 d as a cycle, for 4～6 cycles.

Trial group B was treated with Cinobufacini Tablets combined with CHOP protocol\[vindesine 3 mg/㎡ (maximum dosage: \<4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1～5\], 21 d as a cycle, for 4～6 cycles.

3 mg/㎡ (maximum dosage: \<4mg), d1, 21 d as a cycle, for 4～6 cycles

vindesine

750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles

cyclophosphamide

60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles

100 mg, d1～5, 21 d as a cycle, for 4～6 cycles

prednisone tablets

0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities

Cinobufacini Tablets

Shun-E Yang, Professor

Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.

Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), accounts for 30％～40％ of adults with NHL, and has great heterogeneity in clinical manifestations, histological morphology and prognosis. R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL. After treatment, 50％～60％of patients with DLBCL receive complete remission (CR), 30％～40％ recurrent and 10% will never be cured due to initial and secondary drug tolerance. The study of Tao Wu et al in domestic showed that cinobufacini combined with CHOP protocol had excellent efficacy in the treatment of NHL, with response rate reaching up to 91.7%, and the adverse reactions were mild and tolerable, whereas the response rate of single CHOP was only 62.5%. In the clinical practice of our studies, it was also found that some patients with recurrent DLBCL NHL also had shrunken or disappeared tumors and a survival time of more than 2 years after single administration of cinobufacini tablets for 3\~6 months following the withdrawal of chemotherapy. This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.

Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma

Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study

3-year Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died within 3 years from the start of randomization.

Overall response rate (ORR) that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment. ORR=(CR+ CRu+ PR)cases/total cases×100%.

3-year overall survival rate (OS) that defined as the ratio of study subjects who survived 3 years after randomization

Incidence of Treatment-Emergent adverse events

Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma	NCT02871869	Diffuse, Large ...	vindesine cyclophosphamid... Epirubicin prednisone tabl... Cinobufacini Ta... Rituximab	18 Years - 70 Years	Xinjiang Medical University
Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma	NCT02871869	Diffuse, Large ...	vindesine cyclophosphamid... Epirubicin prednisone tabl... Cinobufacini Ta... Rituximab	18 Years - 70 Years	Xinjiang Medical University

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