NCT00391066

Lumiliximab With Fludarabine, Cyclophosphamide, and Rituximab (FCR) Versus FCR Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects With Relapsed Chronic Lymphocytic Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized (1:1), open-label, multicenter, active-controlled study in patients with previously treated CD23+ and CD20+ relapsed CLL. Patients will receive treatment with either lumiliximab in combination with FCR or FCR alone.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	FCR + Lumiliximab	Dose, schedule, and duration specified in the protocol
DRUG	FCR	Dose, schedule, and duration specified in protocol

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2006-10-23
• Last updated: 2015-10-02

Locations

194 sites across 23 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, India, Israel, Italy, Lithuania, New Zealand, Poland, Portugal, Romania, Russia, Slovakia, Spain, United Kingdom