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
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is to evaluate Overall response rate (ORR)
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
3 years and 2 months
No
Andrés López Hernández, MD
Principal Investigator
Hospital Vall d´Hebrón
Spain: Spanish Agency of Medicines
GEL-TAMO/R-GemOx-08-04/v2
NCT01562977
April 2011
April 2017
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