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

Eisai

Status and phase: Completed; Phase 2

Conditions: Leukemia, Lymphocytic, Chronic

Treatments: Drug: ONTAK

Study type: Interventional

Funder types: Industry

Identifiers

NCT00055146

L4389-34

Details and patient eligibility

About

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

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)