Treatment of Diffuse Large B Cell Lymphoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: Yangzhengxiaoji capsule combined with CHOP regimen; Drug: CHOP regimen

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Oncology Department of The First Affiliated Hospital of Zhengzhou University
      • Contact: Mingzhi Zhang, Dr; Phone Number: 13838565629; Email: mingzhi_zhang@126.com
      • Contact: Mingzhi Zhanf, Dr; Phone Number: 13838565629; Email: mingzhi_zhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yangzhengxiaoji Capsule combined with CHOP regimen; Yangzhengxiaoji Capsule combined with CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen	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.
Experimental: CHOP regimen; CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	up to end of follow-up-phase (approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	up to the date of death (approximately 5 years)

Collaborators and Investigators

• Sponsor: Mingzhi Zhang
• Investigators: Principal Investigator: Mingzhi Zhang, Dr, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 20, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Prednisolone; Cyclophosphamide; Prednisone; Doxorubicin; Vincristine
• Other Study ID Numbers: hnslblzlzx2011-4