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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01949818
Other study ID # hnslblzlzx2011-4
Secondary ID
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


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
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