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Brief Title: CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib
Official Title: A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Study ID: NCT01227577
Brief Summary: "This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer, Burbank, California, United States
Bay Area Cancer Research Dept.ofBayAreaCancerResearch, Concord, California, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Yorba Linda, California, United States
Sarah Cannon Research Institute SCRI, Jacksonville, Florida, United States
Advanced Medical Specialties, Miami, Florida, United States
Pasco Hernando Oncology, New Port Richey, Florida, United States
Georgia Regents University MedCollege of GA Cancer Ctr 2, Augusta, Georgia, United States
Stroger Cook County Hospital Division of Hematology & Onc, Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States
Indiana Blood and Marrow Institute, Beach Grove, Indiana, United States
Cancer Center of Kansas, Witchita, Kansas, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3), New Orleans, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
St. Louis University Cancer Center, St. Louis, Missouri, United States
University of Nebraska Medical Center University of Nebraska Med Ctr, Omaha, Nebraska, United States
Hackensack University Medical Center Dept.of HackensackUniv.MedCtr., Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
University of Rochester Medical Ct James P Wilmot Cancer Ctr, Rochester, New York, United States
Duke University Medical Center Duke University Med Ctr, Durham, North Carolina, United States
Oregon Health & Science University, Portland, Oregon, United States
Cancer Centers of the Carolinas Cancer Center, Greenville, South Carolina, United States
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology, Chattanooga, Tennessee, United States
The Jones Clinic, Germantown, Tennessee, United States
Tennessee Oncology Sarah Cannon Research Inst., Nashville, Tennessee, United States
Baylor Research Institute Baylor Research Institute (17), Dallas, Texas, United States
Oncology Consultants Oncology Consultants, P.A., Houston, Texas, United States
Millennium Oncology, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR