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

Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02767674
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Rituximab Drug: Gemcitabine Drug: Oxaliplatin Drug: Cyclophosphamide Drug: Epirubicin Injectable Product Drug: Vindesine Drug: Prednisone Phase 3

Detailed Description:

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.

Primary Outcome Measures:

• 2-year overall survival rate

Secondary Outcome Measures:

  • 2-year progression free survival rate
  • overall response rate
  • safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: R-GemOx
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Drug: Rituximab
375 mg/m2 IVD day0

Drug: Gemcitabine
Gemcitabine 1 g/m2 IVD day 1

Drug: Oxaliplatin
Oxaliplatin 100 mg/m2 IVD day1

Active Comparator: R-miniCHOP
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
Drug: Rituximab
375 mg/m2 IVD day0

Drug: Cyclophosphamide
Cyclophosphamide 400 mg/m2 IVD d1

Drug: Epirubicin Injectable Product
Epirubicin 35 mg/m2 IVD d1

Drug: Vindesine
Vindesine 2 mg IVP d1

Drug: Prednisone
Prednisone 40mg/m2 PO d1-5




Primary Outcome Measures :
  1. 2-year overall survival rate [ Time Frame: One year ]
    from the date of inclusion to date of death, irrespective of cause


Secondary Outcome Measures :
  1. 2-year progression free survival rate [ Time Frame: One year ]
    from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause

  2. overall response rate [ Time Frame: One year ]
    overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen



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 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
  2. New-diagnosed and untreated;
  3. Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
  4. Ann Arbor stage I to stage IV disease;
  5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
  2. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
  3. Presence of Grade III nervous toxicity with two weeks;
  4. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
  5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
  6. CNS or meningeal involvement;
  7. Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
  8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
  9. Active and severe infectious diseases;
  10. Major surgery within three weeks;
  11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
  12. In any conditions which investigator considered ineligible for this study.
  13. Known sensitivity or allergy to investigational Product.

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): NCT02767674


Contacts
Layout table for location contacts
Contact: Huayuan Zhu, M.D., Ph.D. +86 68136034 huayuan.zhu@hotmail.com
Contact: Wei Xu, M.D., Ph.D. +86 68136034 xuwei10000@hotmail.com

Locations
Layout table for location information
China, Hubei
Tongji Medical College of HUST Recruiting
Wuhan, Hubei, China, 430030
Contact: Jianfeng Zou         
China, Jiangsu
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) Recruiting
NanJing, Jiangsu, China, 21002
Contact: Huayuan Zhu, M.D., Ph.D.    +86 68136034    huayuan.zhu@hotmail.com   
Principal Investigator: Wei Xu, M.D., Ph.D.         
China, Shandong
QiLu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Luqun Wang, M.D., Ph.D.         
Shandong Province Hospital Recruiting
Jinan, Shandong, China, 250021
Contact: Xin Wang, M.D., Ph.D.         
China, Shanghai
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Weili Zhao, M.D., Ph.D.         
Sudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200433
Contact: Ye Guo, M.D., Ph.D.         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Layout table for investigator information
Principal Investigator: Wei Xu, M.D., Ph.D. The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Publications of Results:

Layout table for additonal information
Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02767674    
Other Study ID Numbers: JSPH-002
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by WEI XU, The First Affiliated Hospital with Nanjing Medical University:
R-Gemox
R-miniCHOP
elderly patients with diffuse large B cell lymphoma
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
Gemcitabine
Prednisone
Cyclophosphamide
Rituximab
Oxaliplatin
Epirubicin
Vindesine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents