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Treatment of Diffuse Large B Cell Lymphoma

NCT ID: NCT01949818

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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Conditions

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Diffuse Large B Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yangzhengxiaoji Capsule combined with CHOP regimen

Yangzhengxiaoji Capsule combined with CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Group Type EXPERIMENTAL

Yangzhengxiaoji capsule combined with CHOP regimen

Intervention Type DRUG

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(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

Group Type EXPERIMENTAL

CHOP regimen

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mingzhi Zhang

OTHER

Sponsor Role lead

Responsible Party

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Mingzhi Zhang

The director of oncology department of the first affiliated hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mingzhi Zhang, Dr

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

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Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mingzhi Zhang, Dr

Role: CONTACT

Phone: 13838565629

Email: [email protected]

Facility Contacts

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Mingzhi Zhanf, Dr

Role: primary

Mingzhi Zhang, Dr

Role: backup

Other Identifiers

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hnslblzlzx2011-4

Identifier Type: -

Identifier Source: org_study_id