drugset / Trial / NCT01124526

Efficacy Response Duration and Toxicity of Rituximab, Fludarabine, and Cyclophosphamide (RFC) as 1st Line Treatment and Rituximab (R) in Maintenance Treatment in Follicular Non Hodgkin (FNH) Lymphoma

NCT01124526

Phase 4 Completed 75 enrolled Asociacion Espanola de Hematologia y Hemoterapia
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the rituximab administration with fludarabine and cyclophosphamide results, are better, than the ones obtained with conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and also to determine whether the rituximab administration as maintenance treatment during two years, increase the global clinical responses and the disease free time interval.

Timeline

Start
2004-09
Primary completion
2007-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications