NCT01562977

Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL

Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.

Detailed description

The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.

Conditions

• Aggressive Lymphoma
• Diffuse Large B-cell Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab, Gemcitabine, Oxaliplatin, Dexametasone	until progression or unacceptable toxicity develops, 8 cicles max Rituximab: 375 mg/m2, IV, day 1. Gemcitabine: 1000 mg/m2, IV, day 2. Oxaliplatin: 100 mg/m2, IV, day 2. Dexametasone: 20 mg/day, days 1-3, oral.

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-03-26
• Last updated: 2017-10-30

Locations

28 sites across 1 country: Spain