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.
See protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dose, schedule, and duration in the protocol
Dosage, schedule, and duration in the protocol
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
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University of Florida/Pulmonary, Critical Care & Sleep Medicine
Gainesville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Research Site
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Research Site
Detroit, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Research Site
Hackensack, New Jersey, United States
Vanderbilt University Medical Center-IPF Program
Nashville, Tennessee, United States
Research Site
Seattle, Washington, United States
Research Site
Westmead, New South Wales, Australia
...and 26 more locations