NCT00169195

Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma

Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.

Detailed description

This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of R-GEMOX in refractory/relapsed patients aged from 18 to 75 years with CD20-positive large B-cell lymphoma non eligible for autologous transplantation. It is anticipated that 50 subjects will be enrolled over 4 years (from April 2003/January 2007), but inclusion could stop earlier according to the analysis performed every 5 patients (based on triangular test). The duration of the treatment period is approximately 16 weeks and patients are followed until death. The total duration of the study is expected to be 3 years.

Conditions

• Diffuse Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)

Timeline

• Start date: 2003-04-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2005-09-15
• Last updated: 2015-09-02

Locations

8 sites across 1 country: France