Treatment of Diffuse Large B Cell Lymphoma

Phase 4

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: CHOP regimen; Drug: Yangzhengxiaoji capsule combined with CHOP regimen

• Registration Number: NCT01949818
• Lead Sponsor: Mingzhi Zhang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-09-20
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-25
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-30
• Primary Completion: 2016-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOP regimen	CHOP regimen	CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
Yangzhengxiaoji Capsule combined with CHOP regimen	Yangzhengxiaoji capsule combined with CHOP regimen	Yangzhengxiaoji Capsule combined with CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Primary Outcome Measures

Name	Time	Method
Progression-free survival	up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measures

Name	Time	Method
overall survival	up to the date of death (approximately 5 years)

Trial Locations

Locations (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China