A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase
PRIMARY OBJECTIVES:
I. Compare the rate of molecular response, as measured by the decrease in bcr-abl
transcripts after 12 months of treatment, in patients with previously untreated chronic
phase chronic myelogenous leukemia treated with imatinib mesylate at standard vs increased
dose or dasatinib.
II. Test whether increasing dose of imatinib mesylate from 400 mg/day to 800 mg/day
increases molecular response rate (as measured by decrease in bcr-abl transcript after 12
months of treatment) in these patients.
III. Compare rates of cytogenetic and hematologic response in patients treated with these
regimens.
IV. Compare, preliminarily, the prognostic effects of der(9) and der(22) chromosomal
deletions for response in patients treated with these regimens.
V. Compare, preliminarily, changes in gene expression at pre-treatment vs at relapse or
progression in patients treated with these regimens.
VI. Compare the frequency and severity of the toxic effects of these regimens in these
patients.
VII. Compare, preliminarily, the overall survival and relapse-free survival of patients
treated with these regimens.
OUTLINE:
This is a randomized, multicenter study. Patients are stratified according to Hasford risk
category (low vs intermediate vs high). Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive oral imatinib mesylate once daily.
ARM II: Patients receive oral imatinib mesylate twice daily.
ARM III: Patients receive oral dasatinib twice daily.
In all arms, treatment continues for 5 years in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed for up to 5 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Molecular Response Rate at 12 Months
Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.
pretreatment and after 12 months of treatment
No
Brian Druker
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2009-00764
NCT00070499
August 2004
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Virginia Piper Cancer Institute | Minneapolis, Minnesota 55407 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Puget Sound Oncology Consortium | Seattle, Washington 98109 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Holland Community Hospital | Holland, Michigan 49423 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Big Sky Oncology | Great Falls, Montana 59405 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Eastern Montana Cancer Center | Miles City, Montana 59301 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Medical X-Ray Center | Sioux Falls, South Dakota 57105 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Central Washington Hospital | Wenatchee, Washington 98801 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
City of Hope Medical Center | Duarte, California 91010 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Swedish Covenant Hospital | Chicago, Illinois 60625 |
Mercy Hospital and Medical Center | Chicago, Illinois 60616 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Grandview Hospital | Dayton, Ohio 45405 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Eureka Hospital | Eureka, Illinois 61530 |
Cancer Center of Kansas - Ottawa | Ottawa, Kansas 66067 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Graham Hospital Association | Canton, Illinois 61520 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Deerpath Medical Associates | Lake Forest, Illinois 60045 |
Pekin Hospital | Pekin, Illinois 61554 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Swedish American Hospital | Rockford, Illinois 61104 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Shawnee Mission Medical Center | Shawnee Mission, Kansas 66204 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Research Medical Center | Kansas City, Missouri 64132 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Memorial Medical Center | Springfield, Illinois 62781 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
Providence Medical Center | Kansas City, Kansas 66112 |
Independence Regional Health Center | Independence, Missouri 64050 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Providence Hospital | Southfield, Michigan 48075 |
Oregon Health and Science University | Portland, Oregon 97201 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Kaiser Permanente | Portland, Oregon 97227 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Southern California | Los Angeles, California 90033 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Kaiser Permanente-Santa Teresa-San Jose | San Jose, California 95119 |
Edna Williams Cancer Center at the Baptist Cancer Institute | Jacksonville, Florida 32207 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Saint Anthony's Health | Alton, Illinois 62002 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Midwest Center for Hematology Oncology | Joliet, Illinois 60432 |
North Shore Hematology Oncology | Libertyville, Illinois 60048 |
Good Samaritan Regional Medical Center | Mt. Vernon, Illinois 62864 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Hematology Oncology Associates of Illinois - Skokie | Skokie, Illinois 60076 |
Midwest Cancer Research Group Incorporated | Skokie, Illinois 60077 |
Edward H Kaplan MD and Associates | Skokie, Illinois 60076 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard | Fort Wayne, Indiana 46845 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
McFarland Clinic | Ames, Iowa 50010 |
Memorial Hospital of Arkansas City | Arkansas City, Kansas 67005 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Radiation Oncology Practice Corporation Southwest | Overland Park, Kansas 66210 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Stormont-Vail Regional Health Center | Topeka, Kansas 66604 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Hackley Campus | Muskegon, Michigan 49442 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Saint Joseph's Hospital - Healtheast | Saint Paul, Minnesota 55102 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Southeast Missouri Hospital | Cape Girardeau, Missouri 63701 |
Radiation Oncology Practice Corporation - North | Kansas City, Missouri 64154 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Radiation Oncology Practice Corporation South | Kansas City, Missouri 64114 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint Joseph Health Center | Kansas City, Missouri 64114 |
Liberty Radiation Oncology Clinic | Kansas City, Missouri 64116 |
Truman Medical Center | Kansas City, Missouri 64108 |
Saint Louis-Cape Girardeau CCOP | Saint Louis, Missouri 63141 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Saint Louis Cancer and Breast Institute | Saint Louis, Missouri 63109 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Deaconess Medical Center | Billings, Montana 59107 |
Billings Clinic | Billings, Montana 59107-7000 |
Internal Medicine of Bozeman | Bozeman, Montana 59715 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Community Medical Hospital | Missoula, Montana 59801 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
The North Division of Montefiore Medical Center | Bronx, New York 10466 |
Adirondack Cancer Center | Glens Falls, New York 12801 |
Interlakes Foundation Inc-Rochester | Rochester, New York 14623 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Aultman Health Foundation | Canton, Ohio 44710 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Veteran Affairs Medical Center | Dayton, Ohio 45428 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Saint Rita's Medical Center | Lima, Ohio 45801 |
Mansfield General Hospital-MedCentral Health System | Mansfield, Ohio 44903 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Natalie W Bryant Cancer Center | Tulsa, Oklahoma 74136 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Aria Health-Torresdale Campus | Philadelphia, Pennsylvania 19114 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Sanford Cancer Center-Oncology Clinic | Sioux Falls, South Dakota 57104 |
Sanford University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Audie L Murphy Veterans Affairs Hospital | San Antonio, Texas 78209 |
University Hospital | San Antonio, Texas 78229 |
Saint Joseph Hospital | Bellingham, Washington 98225 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
West Virginia University | Morgantown, West Virginia 26506 |
Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Marshfield Clinic-Wausau Center | Wausau, Wisconsin 54401 |
University of Illinois | Chicago, Illinois 60612 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
York Hospital | York, Maine 03909 |
Denver Veterans Administration Medical Center | Denver, Colorado 80220 |
Montrose Memorial Hospital | Montrose, Colorado 81401 |
Jesse Brown Veterans Affairs Medical Center | Chicago, Illinois 60612 |
DuPage Medical Group-Ogden | Naperville, Illinois 60563 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Syracuse Veterans Administration Medical Center | Syracuse, New York 13210 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
Salina Regional Health Center. | Salina, Kansas 67401 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Hematology Oncology Associates of Central New York PC | East Syracuse, New York 13057 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Saint Francis Hospital - Wilmington | Wilmington, Delaware 19805 |
Illinois Cancer Specialists-Niles | Niles, Illinois 60714 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Riverview Medical Center/Booker Cancer Center | Red Bank, New Jersey 07701 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |