Treatment of Diffuse Large B Cell Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

A Randomized, Controlled Mutiple-center Clinical Research on the Treatment With Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01949818
• Other study ID #: hnslblzlzx2011-4
• Status: Recruiting
• Phase: Phase 4
• First received: September 20, 2013
• Last updated: December 28, 2015
• Start date: September 2012
• Est. completion date: September 2018

Study information

• Verified date: December 2015
• Source: Zhengzhou University
• Contact: Mingzhi Zhang, Dr
• Phone: 13838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Yangzhengxiaoji Capsule Combination Chemotherapy for III/IV Diffuse Large B Cell Lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed Diffuse large B cell lymphoma(III/IV) None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin = 90 g/dl, neutrophil = 1.5×109/L, platelet = 100×109/L, ALT and AST = 2×ULN, serum bilirubin = 1.5×ULN, serum creatine = 1.5×upper limitation of normal (ULN), Serum Albumin = 30g/L At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

Exclusion Criteria:

• Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis History of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Yangzhengxiaoji capsule combined with CHOP regimen
Yangzhengxiaoji capsule combined with CHOP regimen(Yangzhengxiaoji capsule,Cyclophosphamide,Vincristine,Doxorubicin,Prednisone)Yangzhengxiaoji capsule ,1.56g,Tid,p.o,d7-21, Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
• CHOP regimen
CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		up to end of follow-up-phase (approximately 24 months)	No
Secondary	overall survival		up to the date of death (approximately 5 years)	No