Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Biogen

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: IDEC-152

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046488

152-20

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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