To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
70
6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
Research Site
La Jolla, California, United States
Research Site
Baltimore, Maryland, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
Time frame: 48 months
Characterize the safety profile of IDEC-152
Time frame: 48 months
Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
Time frame: 48 months
Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
Time frame: 48 months
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Research Site
Columbus, Ohio, United States
Research Site
Houston, Texas, United States