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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00055146

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Denileukin diftitox

U.S. FDA Resources

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

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

Locations

United States, California
UCSD School of Medicine
La Jolla, California, United States, 92093-0663
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
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
Oncology Day Unit, Frankston Hospital
Frankston, Australia, 3199
Australia, Victoria
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia, 3002
Brazil, GO
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiania, GO, Brazil, 74605-070
Brazil, PR
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, PR, Brazil, 80060-900
Brazil, RJ
Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, RJ, Brazil, 21941-590
Brazil, SP
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-000
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, SP, Brazil, 14784-400
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

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

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Denileukin diftitox
Therapeutic Uses
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on November 25, 2009