The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma. Primary Outcome Measures: • 2-year overall survival rate Secondary Outcome Measures: * 2-year progression free survival rate * overall response rate * safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
375 mg/m2 IVD day0
Gemcitabine 1 g/m2 IVD day 1
Oxaliplatin 100 mg/m2 IVD day1
Tongji Medical College of HUST
Wuhan, Hubei, China
RECRUITINGThe first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
RECRUITINGQiLu Hospital of Shandong University
Jinan, Shandong, China
2-year overall survival rate
from the date of inclusion to date of death, irrespective of cause
Time frame: One year
2-year progression free survival rate
from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause
Time frame: One year
overall response rate
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen
Time frame: One year
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Cyclophosphamide 400 mg/m2 IVD d1
Epirubicin 35 mg/m2 IVD d1
Vindesine 2 mg IVP d1
Prednisone 40mg/m2 PO d1-5
Shandong Province Hospital
Jinan, Shandong, China
RECRUITINGRui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGSudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING