Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Inclusion Criteria:

• Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
• Patients must have received at least one prior purine analogue-based chemotherapy regimen.
• ECOG Performance Status of 0, 1, or 2.
• Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria:

• Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
• Received any therapy for CLL within 35 days prior to study entry.