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
Overview
- Phase
- Phase 2
- Intervention
- Lumiliximab + FCR
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Biogen
- Enrollment
- 40
- Locations
- 6
- Primary Endpoint
- To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment Group A
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
Intervention: Lumiliximab + FCR
Treatment Group B
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
Intervention: FCR
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Time Frame: June 2010
To evaluate the efficacy of FCR+L compared with FCR alone in subjects with previously untreated CLL.
Time Frame: June 2010