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

Phase 3
60 Years
Open (Enrolling)
Aggressive B Cell Lymphoma

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Trial Information

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

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

overall response rate after treated by R±GemOx regimen

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

WEI XU, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jiangsu Province Hospital


China: Ministry of Health

Study ID:




Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Aggressive B Cell Lymphoma
  • Rituximab
  • Gemcitabine
  • Oxaliplatin
  • aggressive B cell lymphoma
  • Aggression
  • Lymphoma
  • Lymphoma, B-Cell