Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

January 1, 2019 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

258

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Medical College of HUST
        • Contact:
          • Jianfeng Zou
    • Jiangsu
      • NanJing, Jiangsu, China, 21002
        • Recruiting
        • The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
        • Principal Investigator:
          • Wei Xu, M.D., Ph.D.
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Luqun Wang, M.D., Ph.D.
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Province Hospital
        • Contact:
          • Xin Wang, M.D., Ph.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Weili Zhao, M.D., Ph.D.
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Sudan University Shanghai Cancer Center
        • Contact:
          • Ye Guo, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival rate
Time Frame: One year
from the date of inclusion to date of death, irrespective of cause
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D., The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 7, 2016

First Submitted That Met QC Criteria

May 7, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 1, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B Cell Lymphoma

Clinical Trials on Rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe