NCT01670370

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

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).

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	R-GemOx	Rituximab Gemcitabine Oxaliplatin

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2019-12-01
• First posted: 2012-08-22
• Last updated: 2019-02-15