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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055146

Enrollment

Registered

2003-02-21

Start date

2003-03-31

Completion date

2006-05-31

Last updated

2009-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphocytic, Chronic

Brief summary

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

Interventions

DRUGONTAK

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Objective Clinical Response	—

Secondary

Measure	Time frame
Time-to-Progression	—
Duration of response	—

Countries

Argentina, Australia, Brazil, Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026