Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Phase 2 Terminated 40 enrolled Biogen

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 2, randomized, open-label, multicenter study in subjects with previously untreated CLL. It is designed to evaluate safety and efficacy of fludarabine, cyclophosphamide, rituximab (FCR) and lumiliximab versus FCR alone.

Timeline

Start: 2008-02
Primary completion: 2010-06
Completion: 2010-09

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumiliximab	Monoclonal antibody	500 mg/m2	—
Comparator	Cyclophosphamide	Other / unclassified	250 mg/m2	—
Comparator	Fludarabine	Small molecule	25 mg/m2	—
Comparator	Rituximab	Monoclonal antibody	500 mg/m2	—

Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Summary

Timeline

Drugs

Indications