Evaluation of Safety and Efficacy of Fludarabine, Cyclophosphamide, and Rituximab (FCR) +/- Lumiliximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Phase 2
Terminated
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Drug: FCR
- Registration Number
- NCT00801060
- Lead Sponsor
- Biogen
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group A Lumiliximab + FCR FCR + Lumiliximab (L) L (Lumiliximab): Day 2 50 mg/m2, Day 4 450 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks. F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks Treatment Group B FCR FCR F (Fludarabine): 25 mg/m2 daily, every four weeks for 21 weeks C (Cyclophosphamide): 250 mg/m2 daily, every four weeks for 21 weeks R: (Rituximab): Day 1 50 mg/m2, Day 3 325 mg/m2, for the first week, then single doses of 500 mg/m2 every four weeks, for 21 weeks
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL. June 2010 To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL. June 2010
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
University of Florida/Pulmonary, Critical Care & Sleep Medicine
🇺🇸Gainesville, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Vanderbilt University Medical Center-IPF Program
🇺🇸Nashville, Tennessee, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Research Site
🇬🇧Bath, Avon, United Kingdom
University of Chicago
🇺🇸Chicago, Illinois, United States