A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
This multicenter, international, phase 3 trial will test the hypothesis that ponatinib is an
effective treatment for newly diagnosed CP-CML patients when compared with standard
imatinib.
Patients will be randomized in a 1:1 fashion, stratified by Sokal risk score at diagnosis
(low, intermediate, high), to receive once daily oral administration of either ponatinib or
imatinib. Efficacy measures include molecular, cytogenetic, and hematologic response rates
at various timepoints; time to, duration of, and durability of responses; and survival
follow-up. Safety measures include clinical laboratory testing, adverse event monitoring,
vital signs, physical exams, ECGs, and ECHOs. Other measures include two patient-reported
health outcomes questionnaires (FACT-Leu and EQ-5D-5L), determination of mutation status,
and, for ponatinib only, measurement of steady-state plasma concentration. Accrual is
expected to take approximately 2 years, and patients will be followed for survival for up to
8 years after the last patient's first dose; therefore, patient participation may last up to
10 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Major Molecular response (MMR) rate
To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
12 months after first dose
No
United States: Food and Drug Administration
AP24534-12-301
NCT01650805
June 2012
June 2021
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center, Site #078 | New York, New York 10065 |
Franciscan St. Francis Health, Site #138 | Indianapolis, Indiana 46237 |
Nebraska Hematology-Oncology, P.C., Site # 133 | Lincoln, Nebraska 68506 |
Mayo Clinic, Site #044 | Rochester, Minnesota 55905 |
Medical University of South Carolina, Site #148 | Charleston, South Carolina 29425 |
Seattle Cancer Care Alliance, Site #100 | Seattle, Washington 98109 |
US Oncology - Providence Health System, Site #167 | Burbank, California 91505 |
UCLA Department of Medicine, Site #027 | Los Angeles, California 90095 |
Bay Area Cancer Research Group, Site #157 | Pleasant Hill, California 94523 |
Bay Area Cancer Research Group, Site #156 | Pleasant Hill, California 94523 |
Rocky Mountain Cancer Centers, Site #191 | Boulder, Colorado 80303 |
Cancer Center of Central Connecticut, Site #147 | Southington, Connecticut 06489 |
Christiana Care Health Services, Site #155 | Newark, Delaware 19713 |
University Cancer Institute, Site #149 | Boynton Beach, Florida 33426 |
Florida Cancer Specialists, Site #180 | Fort Meyers, Florida 33916 |
Florida Cancer Specialists, Site #179 | St. Petersburg, Florida 33705 |
Emory University, Site #058 | Atlanta, Georgia 30322 |
University of Chicago, Site #001 | Chicago, Illinois 60637 |
Loyola University Chicago, Site #054 | Maywood, Illinois 60153 |
University of Iowa Hospitals and Clinics, Site #050 | Iowa City, Iowa 52242 |
US Oncology - Cancer Center of Kansas, Site #168 | Wichita, Kansas 67214 |
Greater Baltimore Medical Center, Site #140 | Baltimore, Maryland 21204 |
University of Maryland, Greenebaum Cancer Center, Site #040 | Baltimore, Maryland 21201 |
Dana Farber Cancer Institute, Site #008 | Boston, Massachusetts 02215 |
Massachusetts General Hospital, Site #047 | Boston, Massachusetts 02114 |
University of Michigan Medical Center, Site #011 | Ann Arbor, Michigan 48109 |
Saint Luke's Hospital, Site #162 | Kansas City, Missouri 64111 |
Mercy Clinic - Cancer & Hematology, Site #151 | Springfield, Missouri 65804 |
US Oncology - Comprehensive Cancer Center of Nevada, Site #169 | Las Vegas, Nevada 89169 |
John Theurer Cancer Center, Site #128 | Hackensack, New Jersey 07601 |
University of New Mexico Cancer Center, Site #166 | Albuquerque, New Mexico 87106 |
Winthrop University Hospital, Site #153 | Mineola, New York 11501 |
Weill Cornell Medical College, Site #006 | New York, New York 10065 |
New York Medical College, Site #146 | Valhalla, New York 10595 |
Signal Point Clinical Research Center, Site #139 | Middletown, Ohio 45042 |
University of Oklahoma, Site #028 | Oklahoma City, Oklahoma 73104 |
Oregon Health & Science University, Site #048 | Portland, Oregon 97239 |
Gettysburg Cancer Center, Site #160 | Gettysburg, Pennsylvania 17325 |
Western Pennsylvania Hospital, Site #159 | Pittsburgh, Pennsylvania 15224 |
Carolina Hematology Oncology, Site #143 | Sumter, South Carolina 29150 |
Sarah Cannon Research Institute, Site #076 | Nashville, Tennessee 37203 |
US Oncology - Texas Oncology Austin, Site #172 | Austin, Texas 78705 |
US Oncology - Texas Oncology Dallas, Site #171 | Dallas, Texas 75231 |
US Oncology - Texas Oncology Midland, Site #173 | Midland, Texas 79701 |
US Oncology - Cancer Care Center of South Texas, Site #170 | San Antonio, Texas 78229 |
Huntsman Cancer Institute, Site #043 | Salt Lake City, Utah 84112 |
US Oncology - Northwest Cancer Specialists, Site #174 | Vancouver, Washington 98684 |
West Virginia University, Site #154 | Morgantown, West Virginia 26506 |