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 DLBCL
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety. Primary Outcome Measures: * overall response rate Secondary Outcome Measures: * progression free survival * overall survival * safety and toxicity Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Rituximab Gemcitabine Oxaliplatin
overall response rate
overall response rate after 3 cycles and at the end of R-GemOx regimen.
Time frame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
progression free survival
from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
Time frame: Two-year
overall survival
from the date of inclusion to date of death, irrespective of cause or last follow-up.
Time frame: Two-year
The incidence and severity of adverse events
All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0
Time frame: Up to 30 days following the last dose of study drug
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