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

Conditions

• Diffuse, Large B-Cell, Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• vindesine — DRUG
  3 mg/㎡ (maximum dosage: \<4mg), d1, 21 d as a cycle, for 4～6 cycles
• cyclophosphamide — DRUG
  750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
• Epirubicin — DRUG
  60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
• prednisone tablets — DRUG
  100 mg, d1～5, 21 d as a cycle, for 4～6 cycles
• Cinobufacini Tablets — DRUG
  0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
• Rituximab — DRUG
  375mg/㎡,one day before CHOP protocol

Study Details

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.

Key Dates

Start date

Sep 30, 2016

Status verified

Jul 2017

Primary completion

Sep 30, 2018

Completion

Dec 31, 2021

Study Design

Enrollment

316 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control group A
  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.
• Experimental: Trial group A
  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.
• Active Comparator: Control group B
  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.
• Experimental: Trial group B
  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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 3 years ]

Central Contacts

• Shun-E Yang, Professor
  13669926688
  [email protected]