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

NCT02871869 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2017-07-17

No results posted yet for this study

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.

Conditions

  • Diffuse, Large B-Cell, Lymphoma

Interventions

DRUG

vindesine

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

DRUG

cyclophosphamide

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

DRUG

Epirubicin

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

DRUG

prednisone tablets

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

DRUG

Cinobufacini Tablets

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

DRUG

Rituximab

375mg/㎡,one day before CHOP protocol

Sponsors & Collaborators

  • Xinjiang Medical University

    lead OTHER

Principal Investigators

  • Shun-E Yang, Professor · Cancer Hospital Affiliated to Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871869 on ClinicalTrials.gov