Spots Global Cancer Trial Database for Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.

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Trial Identification

Brief Title: Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.

Official Title: A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).

Study ID: NCT01670370

Conditions

Diffuse Large B-cell Lymphoma

Interventions

R-GemOx

Study Description

Brief Summary: 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

Detailed Description: 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