NCT00103558

Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, Phase I/II, dose escalation research study of an investigational product called lumiliximab, given with FDA (Food and Drug Administration) approved products fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42 months or until your disease progresses and you require additional CLL therapy. The total duration of participation in the study will be approximately 4 years, however your disease status will be followed indefinitely (forever).

Conditions

• Chronic Lymphocytic Leukemia

Interventions

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

Timeline

• Start date: 2004-03-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2005-02-11
• Last updated: 2015-10-02

Locations

5 sites across 1 country: United States