drugset / Trial / NCT00545714

A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

NCT00545714 ↗

Phase 2 Completed 86 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Timeline

Start
2007-11-21
Primary completion
2016-05-20
Completion
2016-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 250 mg/m2 Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 500 mg/m2 Intravenous