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

April 16, 2009 updated by: Eisai Inc.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective Clinical Response

Secondary Outcome Measures

Outcome Measure
Duration of response
Time-to-Progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Elyane Lombardy, M.D., Ligand Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 19, 2003

First Submitted That Met QC Criteria

February 20, 2003

First Posted (Estimate)

February 21, 2003

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L4389-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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