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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055146
Recruitment Status : Completed
First Posted : February 21, 2003
Last Update Posted : April 17, 2009
Information provided by:
Eisai Inc.

February 19, 2003
February 21, 2003
April 17, 2009
March 2003
March 2006   (Final data collection date for primary outcome measure)
Objective Clinical Response
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Complete list of historical versions of study NCT00055146 on Archive Site
  • Time-to-Progression
  • Duration of response
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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)
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2006
March 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Brazil,   Canada,   United States
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Eisai Inc.
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Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
Eisai Inc.
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP