A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
12 months
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CAMN107A2302
NCT00519090
October 2007
October 2008
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Swedish Cancer Institute | Seattle, Washington 98104 |
Southern California Permanente Medical Group | Downey, California 90242 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Kaiser Permanente Medical Group | Los Angeles, California 90027 |
Indiana Blood and Marrow Transplantation | Indianapolis, Indiana 46202 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
Oregon Health Sciences University | Portland, Oregon |
The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
St. Luke's Hospital and Health Network | Bethlehem, Pennsylvania 18015 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
Duke University Hospital | Durham, North Carolina 27710 |
University of Texas/MD Anderson Cancer Center | Houston, Texas 77030 |
Kaiser Permanente Medical Group/Hayward Medical Center | Hayward, California 94540 |
Kaiser Permanente Medical Group/Oakland Medical Center | Oakland, California 94601 |
Kaiser Permanente Medical Group/South San Francisco Medical Center | S. San Francisco, California 94101 |
Kaiser Permanente Medical Group/Sacramento Medical Center | Sacramento, California 94203 |
Kaiser Permanente Medical Group/Santa Clara Medical Office | Santa Clara, California 95050 |
Kaiser Permanente Medical Group/Vallejo Medical Center | Vallejo, California 94589 |
Kaiser Permanente Medical Group/Walnut Creek Medical Center | Walnut Creek, California 94595 |
Southen California Permanente Medical Group | Woodland Hills, California 91364 |
Holden Cancer Center | Iowa City, Iowa 52240 |
Hematology Centers of Western Michigan | Grand Rapids, Michigan 49501 |
Jones Cancer Center | Germantown, Tennessee 38138 |