NCT00801060

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

A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination With Lumiliximab Versus FCR Alone in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See protocol.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

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

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2008-12-03
• Last updated: 2015-10-02

Locations

36 sites across 8 countries: United States, Australia, Austria, Belgium, Canada, France, Poland, United Kingdom