Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
Phase 1
Completed
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT00046488
- Lead Sponsor
- Biogen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Signed IRB-approved informed consent.
- Greater than 18 years of age
- Proof of CD23+ CLL or small lymphocytic lymphoma (SLL)
- Progressive disease after at least 1 course of chemotherapy
- Acceptable hematologic status, liver function, renal function, and pulmonary function
- Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
Exclusion Criteria
- Previous exposure to IDEC-152 or other anti-CD23 antibodies
- Presence of HIV infection or AIDS
- Serious nonmalignant disease
- Active uncontrolled bacterial, viral or fungal infections.
- Clinically active autoimmune disease
- Pregnant or currently breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Characterize the safety profile of IDEC-152 48 months Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL 48 months
- Secondary Outcome Measures
Name Time Method Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL 48 months Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL 48 months
Trial Locations
- Locations (1)
Research Site
🇺🇸Houston, Texas, United States