drugset / Trial / NCT00641095

Phase III, Multicentre, Randomised Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma

NCT00641095

Phase 2/3 Completed 370 enrolled University College, London Cancer Research UK · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase III trial is comparing how well fludarabine and cyclophosphamide work when given together with or without rituximab in treating patients with previously untreated mantle cell lymphoma.

Timeline

Start
2006-12-07
Primary completion
2011-11-23
Completion
2015-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 250 mg/m2 Oral
Background Fludarabine Small molecule 40 mg/m2 Intravenous

Indications