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Brief Title: Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
Official Title: A Randomized Open-label Study of 400 mg Versus 800 mg of Imatinib Mesylate in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Using Molecular Endpoints.
Study ID: NCT00124748
Brief Summary: This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama, Mobile, Alabama, United States
Alta Bates Comprehsenive Cancer Center, Berkeley, California, United States
University of Miami, Berkeley, California, United States
South Bay Oncology Hematology Partners, Campbell, California, United States
UCLA Medical Center, Los Angeles, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Osler Medical Inc., Melbourne, Florida, United States
Advanced Medical Specialists, Miami, Florida, United States
Integrated Community Oncology Network, Orange Park, Florida, United States
Hematology-Oncology Associates, P.A., Pensacola, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
Rush University Medical Center, Chicago, Illinois, United States
Indiana Blood and Marrow Institutw, Beech Grove, Indiana, United States
Indiana Blood and Marrow Transplant, Beech Grove, Indiana, United States
University of Iowa Hospitals & Clinic, Iowa City, Iowa, United States
University of Kentucky - C201 Clinic, Lexington, Kentucky, United States
University of Kentucky, Lexington, Kentucky, United States
Lousville Oncology, Clinical Research Program M-25, Louisville, Kentucky, United States
Jayne S. Gurtler, MD, Laura A. Brinz, MD & Angelo Russo, MD, Metairie, Louisiana, United States
Hematology and Oncology Specialists, New Orleans, Louisiana, United States
LSU Health Science Center, Shreveport, Louisiana, United States
LSU Health Scine Center, Shreveport, Louisiana, United States
St. Agnes Hospital, Baltimore, Maryland, United States
Great Lakes Cancer Institute, Lansing, Michigan, United States
U of Minnesota, Minneapolis, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cancer Center of the Carolinas, Greenville, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
University Hospitals of Cleveland, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Kaiser Permanente Northwest Region Oncology/Hemacology, Portland, Oregon, United States
Kaiser Permanente Northwest Region, Portland, Oregon, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
University of Pittsburg, Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Cancer Center of the Carolinas, Greenville, South Carolina, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
The Jones Clinic, Germantown, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
UT Southwestern Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
University of Texas / MD Anderson Cancer Center, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Virgina Cancer Center, UVA Division of Hematology & Oncology, Charlottesville, Virginia, United States
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, La Plata, , Argentina
Novartis Investigative Site, St. Leonards, New South Wales, Australia
Novartis Investigative Site, Waratah, New South Wales, Australia
Novartis Investigative Site, Westmead, New South Wales, Australia
Novartis Investigative Site, Herston, Queensland, Australia
Novartis Investigative Site, Woolloongabba, Queensland, Australia
Novartis Investigative Site, Adelaide, South Australia, Australia
Novartis Investigative Site, East Melbourne, Victoria, Australia
Novartis Investigative Site, Fitzroy, Victoria, Australia
Novartis Investigative Site, Frankston, Victoria, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Prahran, Victoria, Australia
Novartis Investigative Site, South Brisbane, , Australia
Novartis Investigative Site, Campinas, , Brazil
Novartis Investigative Site, Calgary, , Canada
Novartis Investigative Site, Montreal, , Canada
Novartis Investigative Site, Ottawa, , Canada
Novartis Investigative Site, Quebec, , Canada
Novartis Investigative Site, Bologna, , Italy
Novartis Investigative Site, Firenze, , Italy
Novartis Investigative Site, Milano, , Italy
Novartis Investigative Site, Napoli, , Italy
Novartis Investigative Site, Orbassano, , Italy
Novartis Investigative Site, Roma, , Italy
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR