This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Hines, Illinois, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Paducah, Kentucky, United States
Unnamed facility
Lafayette, Louisiana, United States
Unnamed facility
Jackson, Mississippi, United States
Unnamed facility
Tupelo, Mississippi, United States
...and 10 more locations
Campath vs. chlorambucil
survival comparison
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