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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Denileukin diftitox

Criteria

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.