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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate
overall response rate after treated by R±GemOx regimen
one year
No
WEI XU, M.D., Ph.D.
Principal Investigator
Jiangsu Province Hospital
China: Ministry of Health
JSPH-001
NCT01670370
January 2012
December 2013
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