Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Eisai Medical Research Inc. |
---|---|
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00055146 |
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 |
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) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
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 |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Denileukin diftitox Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell |
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 |