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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
3 mg/㎡ (maximum dosage: \<4mg), d1, 21 d as a cycle, for 4~6 cycles
750 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
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
0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
375mg/㎡,one day before CHOP protocol
Cancer Hospital Affiliated to Xinjiang Medical University
Ürümqi, Xinjiang, China
RECRUITINGProgression-free survival (PFS)
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.
Time frame: 3 years
Overall response rate (ORR)
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%.
Time frame: 2 years
overall survival rate (OS)
3-year overall survival rate (OS) that defined as the ratio of study subjects who survived 3 years after randomization
Time frame: 3 years
Safety and Tolerability
Incidence of Treatment-Emergent adverse events
Time frame: 2 years
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Time frame: 2 years
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