|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Biogen Idec |
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00391066 |
Purpose
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.
| Condition | Intervention | Phase |
|
Chronic Lymphocytic Leukemia |
Drug: Lumiliximab Drug: FCR |
Phase II Phase III |
| MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab Lumiliximab |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open Label, Multicenter, Phase 2/3 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 |
| Estimated Enrollment: | 900 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
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 |
Drug: FCR
Dose, schedule, and duration specified in protocol
|
|
2: Experimental
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 |
Drug: Lumiliximab
Dose, schedule, and duration specified in the protocol
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Biogen Idec | oncologyclinicaltrials@biogenidec.com |
![]() |
Show 95 Study Locations |
| Biogen Idec |
More Information
| Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
| Study ID Numbers: | 152CL201 |
| First Received: | October 19, 2006 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00391066 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|