Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients.
12 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CAMN107A2303E1
NCT00718263
April 2008
October 2018
Name | Location |
---|---|
Tyler Cancer Center | Tyler, Texas 75702 |
Utah Cancer Specialists | Salt Lake City, Utah 84106 |
Florida Cancer Institute | New Port Richey, Florida 34652 |
Kansas City Cancer Center KCCC Business Office | Overland Park, Kansas 66210 |
UCLA/ University of California Los Angeles Dept. of Hematology Clinic | Los Angeles, California 90095 |
Kaiser Permanente - California Southern Dept of Kaiser South 3 | San Diego, California |
Kaiser Permanente - California Southern Dept of Kaiser South 12 | San Diego, California |
Kaiser Permanente - California Northern Kaiser Med | Vallejo, California |
Kaiser Permanente - California Northern Vallejo Med Center/Med Offices | Vallejo, California |
Rocky Mountain Cancer Centers RMCC - Colorado Springs | Greenwood Village, Colorado |
Florida Cancer Specialists Dept. FloridaCancerSpecialists | Fort Myers, Florida 33901 |
Advanced Medical Specialties Research Dept. | Miami, Florida 33176 |
Cancer Centers of Florida PA Cancer Centers of FL | Ocoee, Florida *see dep* |
University of Chicago Medical Center Section of Hematology/Oncology | Chicago, Illinois 60546 |
Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow | Beach Grove, Indiana 46107 |
University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics | Iowa City, Iowa 52242 |
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center | New Orleans, Louisiana 70115 |
Michigan State University / Breslin Cancer Center Breslin Cancer Center | Lansing, Michigan |
Missouri Cancer Associates Dept. of Boone Hospital Center | Columbia, Missouri 65201 |
Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants | St. Louis, Missouri 63136 |
Hackensack University Medical Center Department of Research | Hackensack, New Jersey 07601 |
Memorial Sloan Kettering Cancer Center Clinical Trials Office | New York, New York 10021 |
UNC/Lineberg Comprehensive Cancer Center UNC Lineberger Cancer Center | Chapel Hill, North Carolina 27514 |
Cancer Centers of North Carolina Cancer Centers of NC-Raleigh | Raleigh, North Carolina 27609 |
Wake Forest University Baptist Medical Center Dept. of Industry Research | Winston-Salem, North Carolina 27157 |
University of Cincinnati / Barrett Cancer Center Dept.of Internal Med. | Cincinnati, Ohio 45219 |
Northwest Cancer Specialists Vancouver Location | Portland, Oregon 97210 |
Cancer Centers of the Carolinas CC of C -Eastside | Greenville, South Carolina 29605 |
Chattanooga Oncology and Hematology Assoicates, PC Memorial Plaza | Chattanooga, Tennessee 37404 |
Tennessee Oncology Dept. of Centennial Medical | Nashville, Tennessee 37203 |
Texas Cancer Center ( Medical City Dallas Hospital) | Dallas, Texas 75230 |
Cancer Care Centers of South Texas / HOAST CCC of So.TX- Medical Center | San Antonio, Texas 78229 |
Cleveland Clinic Foundation Dept.ofTaussigCancerCenter(2) | Cleveland, Ohio 44195 |