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

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

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for:

Denileukin diftitox

U.S. FDA Resources

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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Objective Clinical Response

Secondary Outcome Measures:

Time-to-Progression
Duration of response

Estimated Enrollment:	41
Study Start Date:	March 2003

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

Contacts


Contact: Ligand Pharmaceuticals (Clinical Trial Sponsor)	1-800-964-5836

Locations


United States, California
	UCSD School of Medicine	Recruiting
	La Jolla, California, United States, 92093-0663
	Pacific Coast Hematology/Oncology Medical Group, Inc.	Recruiting
	Fountain Valley, California, United States, 92708

United States, Illinois
	Rush-Presbyterian St. Luke's Cancer Center	Recruiting
	Chicago, Illinois, United States, 60612

United States, New York
	Weill Medical College of Cornell University/New York Presbyterian Hospital	Recruiting
	New York, New York, United States, 10021

United States, Texas
	University of Texas, M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030

Argentina
	Montecaseros	Recruiting
	Mendoza, Argentina, 5500

Australia
	Oncology Day Unit, Frankston Hospital	Recruiting
	Frankston, Australia, 3199

Australia, Victoria
	Peter MacCallum Cancer Institute	Recruiting
	East Melbourne, Victoria, Australia, 3002

Brazil, GO
	Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias	Recruiting
	Goiania, GO, Brazil, 74605-070

Brazil, PR
	Hospital de Clinicas da Universidade Federal do Parana	Recruiting
	Curitiba, PR, Brazil, 80060-900

Brazil, RJ
	Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho	Recruiting
	Rio de Janeiro, RJ, Brazil, 21941-590

Brazil, SP
	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Recruiting
	Sao Paulo, SP, Brazil, 05403-000
	Hospital de Cancer de Barretos - Fundacao Pio XII	Recruiting
	Barretos, SP, Brazil, 14784-400

Canada, Quebec
	Sir Mortimer B. Davis - Jewish General Hospital	Recruiting
	Montreal, Quebec, Canada, H3T 1E2

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators


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

More Information

Study ID Numbers:	L4389-34
First Received:	February 19, 2003
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00055146
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Leukemia, Lymphocytic, Chronic, B-Cell

Denileukin diftitox

Lymphoproliferative Disorders

Leukemia, B-Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00055146