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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen

Criteria

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