Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)
NCT00103558 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2015-10-02
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
Interventions
- DRUG
-
Lumiliximab with FCR
Dose, schedule, and duration specified in protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-03-31
Countries
- United States
Study Locations
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