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Status unknownNCT01949818Updated Dec 30, 2015

Treatment of Diffuse Large B Cell Lymphoma

A Phase 4 interventional study of Yangzhengxiaoji capsule combined with CHOP regimen and CHOP regimen in Diffuse Large B Cell Lymphoma, sponsored by Mingzhi Zhang. Status unknown at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by Mingzhi Zhang · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
14 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diffuse Large B Cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Mingzhi Zhang is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Yangzhengxiaoji Capsule combined with CHOP regimen

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

    Drug: Yangzhengxiaoji capsule combined with CHOP regimen

  • Experimental
    CHOP regimen

    CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen

    Drug: CHOP regimen

Interventions

  • DrugYangzhengxiaoji 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.

  • DrugCHOP 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

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: up to end of follow-up-phase (approximately 24 months)

Secondary outcomes

  1. overall survival

    Time frame: up to the date of death (approximately 5 years)

07

Study locations

1 of 1 sites recruiting
  • Oncology Department of The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450052, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01949818
Lead sponsor
Mingzhi Zhang
Responsible party
Mingzhi Zhang (The director of oncology department of the first affiliated hospital, Zhengzhou University) — Sponsor-investigator
First posted
Sep 25, 2013
Start date
Sep 2012
Primary completion
Sep 2016 (estimated)
Completion
Sep 2018 (estimated)
Last update
Dec 30, 2015

Study contacts

Mingzhi Zhang, Dr
Contact
Mingzhi_zhang@126.com
13838565629
Mingzhi Zhang, Dr
principal investigator · The First Affiliated Hospital of Zhengzhou University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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