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

This study is currently recruiting participants.
Verified August 2012 by Jiangsu Province Hospital
Sponsor:
Information provided by (Responsible Party):
WEI XU, Jiangsu Province Hospital
ClinicalTrials.gov Identifier:
NCT01670370
First received: August 7, 2012
Last updated: August 19, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Aggressive B Cell Lymphoma
Drug: R-GemOx
Drug: GemOx
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of GemOx±R Regimen in First-line Treatment of Elderly Aggressive B Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Hospital:

Primary Outcome Measures:
  • overall response rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    overall response rate after treated by R±GemOx regimen


Secondary Outcome Measures:
  • progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    the length of time during and after treatment during which the disease being treated does not get worse.

  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
    the time frame of enrolled patients from diagnosed to death.

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


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670370

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

Locations
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.         
JiangSu Province Hospital Recruiting
NanJing, Jiangsu, China, 210029
Contact: LEI FAN, Dr.    86 25 6813 6034      
Principal Investigator: WEI XU, 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.         
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
WEI XU
Investigators
Principal Investigator: WEI XU, M.D., Ph.D. Jiangsu Province Hospital
  More Information

Publications:
Responsible Party: WEI XU, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier: NCT01670370     History of Changes
Other Study ID Numbers: JSPH-001
Study First Received: August 7, 2012
Last Updated: August 19, 2012
Health Authority: China: Ministry of Health

Keywords provided by Jiangsu Province Hospital:
Rituximab
Gemcitabine
Oxaliplatin
aggressive B cell lymphoma

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

ClinicalTrials.gov processed this record on April 16, 2014