Spots Global Cancer Trial Database for Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
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Trial Identification
Brief Title: Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Official Title: A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
Study ID: NCT00519090
Conditions
Study Description
Brief Summary: In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Detailed Description: This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
Southern California Permanente Medical Group, Anaheim, California, United States
Southern California Permanente Medical Group, Baldwin Park, California, United States
Southern California Permanente Medical Group, Fontana, California, United States
Kaiser Permanente Medical Group/Hayward Medical Center, Hayward, California, United States
Southern California Permanente Medical Group, Los Angeles, California, United States
Kaiser Permanente Medical Group/Oakland Medical Center, Oakland, California, United States
Southern California Permanente Medical Group, Panorama City, California, United States
Southern California Permanente Medical Group, Riverside, California, United States
Kaiser Permanente Medical Group/South San Francisco Medical Center, S. San Francisco, California, United States
Kaiser Permanente Medical Group/Sacramento Medical Center, Sacramento, California, United States
Southern California Permanente Medical Group, San Diego, California, United States
Kaiser Permanente Medical Group, San Francisco, California, United States
Kaiser Permanente Medical Group, San Jose, California, United States
Kaiser Permanente Medical Group/Santa Clara Medical Office, Santa Clara, California, United States
Kaiser Permanente Medical Group/Vallejo Medical Center, Vallejo, California, United States
Kaiser Permanente Medical Group/Walnut Creek Medical Center, Walnut Creek, California, United States
Southen California Permanente Medical Group, Woodland Hills, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation, Beech Grove, Indiana, United States
Holden Cancer Center, Iowa City, Iowa, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Methodist Cancer Center, Omaha, Nebraska, United States
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Duke University Hospital, Durham, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Oregon Health Sciences University, Portland, Oregon, United States
St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania, United States
Jones Cancer Center, Germantown, Tennessee, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Texas/MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Novartis Investigative Site, Darlinghurst, , Australia
Novartis Investigative Site, Herston, , Australia
Novartis Investigative Site, Liverpool, , Australia
Novartis Investigative Site, Perth, , Australia
Novartis Investigative Site, Prahran, , Australia
Novartis Investigative Site, South Brisbane, , Australia
Novartis Investigative Site, St. Leonards, , Australia
Novartis Investigative Site, Brugge, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Mannheim, , Brazil
Novartis Investigative Site, Porto Alegre, , Brazil
Novartis Investigative Site, Sao Paulo, , Brazil
Novartis Investigative Site, Olomouc, , Czech Republic
Novartis Investigative Site, Praha, , Czech Republic
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Duesseldorf, , Germany
Novartis Investigative Site, Eisensach, , Germany
Novartis Investigative Site, Firenze, , Germany
Novartis Investigative Site, Griefswald, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Jena, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Leipzeg, , Germany
Novartis Investigative Site, Postsdam, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Stuttgart, , Germany
Novartis Investigative Site, Weiden, , Germany
Novartis Investigative Site, Bologna, , Italy
Novartis Investigative Site, Milano, , Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Orbassano, , Italy
Novartis Investigative Site, Reggio Calabra, , Italy
Novartis Investigative Site, Roma, , Italy
Novartis Investigative Site, Nagoya, , Japan
Novartis Investigative Site, Oaska, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Hwasun-Gun, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Salamanca, , Spain
Novartis Investigative Site, Santiago de Compostela, , Spain
Novartis Investigative Site, Valencia, , Spain
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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