drugset / Trial / NCT02871869

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

NCT02871869

Phase 2/3 Unknown 316 enrolled Xinjiang Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-09
Primary completion
2018-09
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject buformin Small molecule 0.9 g Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2
Background Epirubicin Small molecule 60 mg/m2
Background Prednisone Other / unclassified 100 mg
Background Vindesine Small molecule 3 mg/m2