A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Completed · Phase 3
Conditions studied: Myelogenous Leukemia, Chronic
In brief
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
Key facts
- Study ID
- NCT00471497
- Run by
- Novartis Pharmaceuticals
- People needed
- 846
- Starts
- 2007-07-31
- Expected to finish
- 2019-08-21
- Last updated by the study team
- 2020-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Kaiser Permanente - California Southern Dept of Kaiser South 3 — San Diego, California, United States
- Kaiser Permanente - California Northern Vallejo Med Center/Med Offices — Vallejo, California, United States
- Kaiser Permanente - California Northern Kaiser Med — Vallejo, California, United States
- Rocky Mountain Cancer Centers RMCC - Colorado Springs — Greenwood Village, Colorado, United States
- Florida Cancer Specialists Dept. FloridaCancerSpecialists — Fort Myers, Florida, United States
- Advanced Medical Specialties Research Dept. — Miami, Florida, United States
- Cancer Centers of Florida PA Cancer Centers of FL — Ocoee, Florida, United States
- Florida Retina Institute Flordia Cancer Affilates — Orlando, Florida, United States
- University of Chicago Section of Hematology/Oncology — Chicago, Illinois, United States
- Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow — Beech Grove, Indiana, United States
- University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics — Iowa City, Iowa, United States
- Kansas City Cancer Center KCCC Business Office — Overland Park, Kansas, United States
- LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center — New Orleans, Louisiana, United States
- Michigan State University / Breslin Cancer Center Breslin Cancer Center — Lansing, Michigan, United States
- Missouri Cancer Associates Dept. of Boone Hospital Center — Columbia, Missouri, United States
- Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants — St Louis, Missouri, United States
- Hackensack University Medical Center Department of Research — Hackensack, New Jersey, United States
- Memorial Sloan Kettering Cancer Center Clinical Trials Office — New York, New York, United States
- University of North Carolina UNC Lineberger Cancer Center — Chapel Hill, North Carolina, United States
- Wake Forest University Health Sciences Dept. of Industry Research — Winston-Salem, North Carolina, United States
- University of Cincinnati / Barrett Cancer Center Dept.of Internal Med. — Cincinnati, Ohio, United States
- Cleveland Clinic Foundation CCF — Cleveland, Ohio, United States
- Northwest Cancer Specialists Compass Oncology -BKM — Portland, Oregon, United States
- Cancer Centers of the Carolinas CC of C -Eastside — Greenville, South Carolina, United States
- University of California at Los Angeles Dept. of Hematology Clinic — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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