Spots Global Cancer Trial Database for An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
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Trial Identification
Brief Title: An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
Official Title: An Extension to a Phase II Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
Study ID: NCT00171223
Interventions
Study Description
Brief Summary: During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Medical Center, Los Angeles, California, United States
H. Lee Moffet Cancer Center & Research Institute/Univ of South Florida, Tampa, Florida, United States
Northwestern Univ meical School/Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
Dana Faber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Wayne State University/Kamanos Cancer Center, Detroit, Michigan, United States
C/O V. Ward - Washington Univ. school of Medicine, Saint Louis, Missouri, United States
New York Presbyterian Hospital, New York, New York, United States
Oregon Health & sciences University, Portland, Oregon, United States
MD Anderson Cancer Center, University of Texas, Houston, Texas, United States
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Pessac, , France
Novartis Investigative Site, Poitiers, , France
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Mainz, , Germany
Novartis Investigative Site, Mannheim, , Germany
Novartis Investigative Site, Bologna, , Italy
Novartis Investigative Site, Milano, , Italy
Novartis Investigative Site, Monza, , Italy
Novartis Investigative Site, Orbassano, , Italy
Novartis Investigative Site, Pavia, , Italy
Novartis Investigative Site, Rome, , Italy
Novartis Investigative Site, Udine, , Italy
Novartis Investigative Site, Basel, , Switzerland
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Newcastle upon Tyne, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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