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Trial of GemOx±R Regimen in First-line Treatment of Elderly Aggressive B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01670370
Recruitment Status : Unknown
Verified August 2012 by WEI XU, Jiangsu Province Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):
WEI XU, Jiangsu Province Hospital

Brief Summary:
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with aggressive B cell lymphoma.

Condition or disease Intervention/treatment Phase
Aggressive B Cell Lymphoma Drug: R-GemOx Drug: GemOx Phase 3

Detailed Description:

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Until now there is no clinical trial to evaluate its role in patients with elderly aggressive B cell lymphoma. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen to treat elderly aggressive B cell lymphoma and investigate its safety and efficacy.

Primary Outcome Measures:

  • overall response rate

Secondary Outcome Measures:

  • progression free survival
  • overall survival
  • safety and toxicity

Enrollment: 100 Study Start Date: January 2012 Primary Completion Date: Dec 2012

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of GemOx±R Regimen in First-line Treatment of Elderly Aggressive B Cell Lymphoma
Study Start Date : January 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Drug: R-GemOx
Rituximab Gemcitabine Oxaliplatin
Other Names:
  • Rituximab
  • Gemcitabine
  • Oxaliplatin
Active Comparator: Gemcitabine+oxaliplatin (GemOx)
Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Drug: GemOx
Gemcitabine oxaliplatin
Other Names:
  • Gemcitabine
  • oxaliplatin

Primary Outcome Measures :
  1. overall response rate [ Time Frame: one year ]
    overall response rate after treated by R±GemOx regimen

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: one year ]
    the length of time during and after treatment during which the disease being treated does not get worse.

  2. overall survival [ Time Frame: one year ]
    the time frame of enrolled patients from diagnosed to death.

  3. Number of participants with adverse events [ Time Frame: Up to 30 days following the last dose of study drug ]
    All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed aggressive B cell lymphoma;
  2. New-diagnosed and untreated;
  3. Age older than 70 years or older than 60 years with ECOG PS ≥ 2;
  4. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Inadequate hepatic, nephritic and cardiac function:total bilirubin, ALT, AST,Cr more than two fold of upper normal level. cardiac function more than Grade II;
  2. Presence of Grade III nervous toxicity with two weeks;
  3. HBV virus load(HBV DNA)> 1×10E5 copies/ml;
  4. Concomitant malignancy other than aggressive B cell lymphoma and need to treat;
  5. Concomitant with other hematologic diseases(such as leukemia,hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
  6. Active and severe infectious diseases;
  7. Major surgery within three weeks;
  8. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
  9. In any conditions which investigator considered ineligible for this study. 10. 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): NCT01670370

Contact: LEI FAN, M.D., Ph.D. 86 25 6813 6034 fanlei_fl@yahoo.com.cn

China, Jiangsu
ChangZhou First People's Hospital Recruiting
ChangZhou, Jiangsu, China, 213003
Contact: XiangShan Cao, M.D., Ph.D.         
Principal Investigator: XiangShan Cao, M.D., Ph.D.         
ChangZhou No.2 People's Hospital Recruiting
ChangZhou, Jiangsu, China, 213011
Contact: Min Zhou, Dr.         
Principal Investigator: Min Zhou, M.D.         
HuaiAn First People's Hospital Recruiting
HuaiAn, Jiangsu, China, 223300
Contact: Liang Yu, Dr.         
Principal Investigator: Liang Yu, M.D., Ph.D.         
NanJing First People's Hospital Recruiting
NanJing, Jiangsu, China, 210006
Contact: YanLi Xu, Dr.         
Principal Investigator: YanLi Xu, M.D., Ph.D.         
JiangSu Province Hospital Recruiting
NanJing, Jiangsu, China, 210029
Contact: LEI FAN, Dr.    86 25 6813 6034      
Principal Investigator: WEI XU, M.D., Ph.D.         
WuXi People's Hospital Recruiting
WuXi, Jiangsu, China, 214023
Contact: Yun Zhuang, M.D.         
Principal Investigator: YunFeng Shen, M.D., Ph.D.         
ZhenJiang First People's Hospital Recruiting
ZhenJiang, Jiangsu, China, 212002
Contact: Yan Zhu, Dr.         
Principal Investigator: Yan Zhu, M.D., Ph.D.         
Sponsors and Collaborators
Principal Investigator: WEI XU, M.D., Ph.D. The First Affiliated Hospital with Nanjing Medical University

Responsible Party: WEI XU, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier: NCT01670370     History of Changes
Other Study ID Numbers: JSPH-001
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by WEI XU, Jiangsu Province Hospital:
aggressive B cell lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Behavioral Symptoms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents