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 (RGemOx)

NCT01562977 Phase 2 COMPLETED

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

Details

Lead sponsor	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Phase	Phase 2
Status	COMPLETED
Enrolment	82
Start date	2011-04
Completion	2015-04

Conditions

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

Interventions

• Rituximab, Gemcitabine, Oxaliplatin, Dexametasone

Primary outcomes

• The primary endpoint is to evaluate Overall response rate (ORR) — 3 years and 2 months
  The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days

Countries

Spain