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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.

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)

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic Drug: ONTAK Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
Study Start Date : March 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : May 2006

Primary Outcome Measures :
  1. Objective Clinical Response

Secondary Outcome Measures :
  1. Time-to-Progression
  2. Duration of response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055146

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United States, California
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
UCSD School of Medicine
La Jolla, California, United States, 92093-0663
United States, Illinois
Rush-Presbyterian St. Luke's Cancer Center
Chicago, Illinois, United States, 60612
United States, New York
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, United States, 10021
United States, Texas
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Mendoza, Argentina, 5500
Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 3002
Oncology Day Unit, Frankston Hospital
Frankston, Australia, 3199
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiania, GO, Brazil, 74605-070
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, PR, Brazil, 80060-900
Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, RJ, Brazil, 21941-590
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, SP, Brazil, 14784-400
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-000
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Eisai Inc.
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Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals

Layout table for additonal information Identifier: NCT00055146     History of Changes
Other Study ID Numbers: L4389-34
First Posted: February 21, 2003    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Denileukin diftitox
Antineoplastic Agents