Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
- Registration Number
- NCT00519090
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nilotinib (AMN107) Nilotinib (AMN107) - Imatinib Imatinib -
- Primary Outcome Measures
Name Time Method Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib 12 months Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
- Secondary Outcome Measures
Name Time Method Durable Complete Cytogenetic Response Rate 24 months Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Trial Locations
- Locations (30)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Southen California Permanente Medical Group
🇺🇸Woodland Hills, California, United States
Indiana Blood and Marrow Transplantation
🇺🇸Beech Grove, Indiana, United States
Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
St. Luke's Hospital and Health Network
🇺🇸Bethlehem, Pennsylvania, United States
The Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Kaiser Permanente Medical Group/Oakland Medical Center
🇺🇸Oakland, California, United States
Holden Cancer Center
🇺🇸Iowa City, Iowa, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Jones Cancer Center
🇺🇸Germantown, Tennessee, United States
Kaiser Permanente Medical Group/Hayward Medical Center
🇺🇸Hayward, 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
🇺🇸San Jose, California, United States
Kaiser Permanente Medical Group/South San Francisco Medical Center
🇺🇸S. San Francisco, California, United States
Kaiser Permanente Medical Group/Walnut Creek Medical Center
🇺🇸Walnut Creek, California, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
University of Texas/MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Kaiser Permanente Medical Group/Sacramento Medical Center
🇺🇸Sacramento, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Novartis Investigative Site
🇪🇸Valencia, Spain
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States