Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03513601
Recruitment Status : Unknown
Verified April 2018 by Mingzhi Zhang, Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

Brief Summary:
To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: (R)-CHOP regimen Drug: (R)-CVP regimen Phase 4

Detailed Description:
The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: (R)-CHOP regimen
(R)-CHOP regimen((rituximab),cyclophosphamide,epirubicin,vincristine and prednisone),(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.
Drug: (R)-CHOP regimen
(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.
Other Name: (rituximab),CTX,VCR,EPI,PDN

Experimental: (R)-CVP regimen
(R)-CVP regimen((rituximab),cyclophosphamide,vincristine and prednisone) The dose of the chemical was reduced by 20%,(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt), oral cyclophosphamide .
Drug: (R)-CVP regimen
The dose of the chemical was reduced by 20%,(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt), oral cyclophosphamide .
Other Name: (rituximab),CTX,VCR,PDN,20 percent reduction in chemical therapy




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to end of follow-up-phase(approximately 24 months) ]
    Progression-free survival


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to the date of death (approximately 5 years) ]
    overall survival

  2. disease control rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )] ]
    disease control rate

  3. objective remission rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )] ]
    objective remission rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 70 years old,Pathology proved to be diffuse large B cell lymphoma,Estimated survival time > 3 months,None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;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.

volunteers who signed informed consent.

Exclusion Criteria:

  • Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513601


Contacts
Layout table for location contacts
Contact: Mingzhi zhang, Pro,Dr 13838565629 Mingzhi_zhang@126.com
Contact: Mingzhi zhang 13838565629 Mingzhi_zhang@126.com

Locations
Layout table for location information
China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629    mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang
Investigators
Layout table for investigator information
Principal Investigator: Mingzhi zhang The First Affiliated Hospital of Zhengzhou University
Layout table for additonal information
Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT03513601    
Other Study ID Numbers: hnslblzlzx2017-10
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mingzhi Zhang, Zhengzhou University:
Curative effect evaluation
Adverse reactions
Clinical characteristics
PR
PFS
OS
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents