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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00055146
First received: February 19, 2003
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic
Drug: ONTAK
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Objective Clinical Response

Secondary Outcome Measures:
  • Time-to-Progression
  • Duration of response

Estimated Enrollment: 41
Study Start Date: March 2003
Study Completion Date: May 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055146

Locations
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
Argentina
Montecaseros
Mendoza, Argentina, 5500
Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 3002
Australia
Oncology Day Unit, Frankston Hospital
Frankston, Australia, 3199
Brazil
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.
Investigators
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055146     History of Changes
Other Study ID Numbers: L4389-34
Study First Received: February 19, 2003
Last Updated: April 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 22, 2014