NCT00070499

Brief Summary

This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for phase_2

Timeline
10mo left

Started Aug 2004

Longer than P75 for phase_2

Geographic Reach
2 countries

341 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2004Mar 2027

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
10 months until next milestone

Study Start

First participant enrolled

August 15, 2004

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 10, 2012

Completed
14.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2027

Expected
Last Updated

May 1, 2026

Status Verified

February 1, 2026

Enrollment Period

6.2 years

First QC Date

October 3, 2003

Results QC Date

June 5, 2012

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Hematologic Response

    1 month after starting treatment

  • 2-year Overall Survival (OS)

    Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5

  • Two Year Relapse-free Survival

    every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5

  • Toxicity

    Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.

Study Arms (3)

Arm I (QD imatinib mesylate)

EXPERIMENTAL

Patients receive imatinib mesylate PO QD. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Drug: Imatinib MesylateOther: Laboratory Biomarker Analysis

Arm II (BID imatinib mesylate)

EXPERIMENTAL

Patients receive imatinib mesylate PO BID. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Drug: Imatinib MesylateOther: Laboratory Biomarker Analysis

Arm III (dasatinib)

EXPERIMENTAL

Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Drug: DasatinibOther: Laboratory Biomarker Analysis

Interventions

Given PO

Also known as: CGP 57148, CGP 57148B, CGP-57148, CGP-57148B, CGP57148, CGP57148B, Gleevec, Glivec, Imarech, Imat, Imkeldi, STI 571, STI-571, STI571
Arm I (QD imatinib mesylate)Arm II (BID imatinib mesylate)

Correlative studies

Arm I (QD imatinib mesylate)Arm II (BID imatinib mesylate)Arm III (dasatinib)

Given PO

Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel
Arm III (dasatinib)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration
  • Patients must be registered on this study within 180 days after the date of first being diagnosed with CML, based on a cytogenetic or molecular analysis of peripheral blood or bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation or testing positive for Bcr-Abl by real time-polymerase chain reaction (RT-PCR); patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
  • Patients must have Zubrod performance status 0-2
  • Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide
  • Patients must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization; (prior collection of unmobilized peripheral blood stem cells is permitted)
  • Serum bilirubin =\< 2.0 x the institutional upper limit of the normal (IULN)
  • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =\< 2.0 x the IULN
  • Patients (Southwestern Oncology Group \[SWOG\] institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients;" collection of the pretreatment bone marrow specimen must be completed within 28 days prior to registration; the pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetic analysis as described, and an aliquot of the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be submitted for fluorescent in situ hybridization (FISH) analysis; note that protocol SWOG-9007 also requires submission of bone marrow specimens at the time of progression to the accelerated or blastic phase of CML or the loss of complete hematologic response and every six months while the patient is on this study
  • Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary;" specimens of peripheral blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid Leukemia and CML Centralized Laboratory in Seattle, Washington; collection of pretreatment blood and marrow specimens must be completed within 28 days prior to registration; note that this study also requires submission of peripheral blood and bone marrow specimens at various times after entry into the study
  • Patients must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
  • Patients must have an electrocardiogram (ECG) within 42 days prior to registration, and must not have any of the following cardiac symptoms prior to entry on study:
  • Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within 6 months of study entry
  • Diagnosed or suspected congenital long QT syndrome
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (341)

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Montrose Memorial Hospital

Montrose, Colorado, 81401, United States

Location

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Saint Francis Hospital - Wilmington

Wilmington, Delaware, 19805, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital Association

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Jesse Brown Veterans Affairs Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Heartland Cancer Research NCORP

Decatur, Illinois, 62526, United States

Location

Eureka Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex - Hospital

Hopedale, Illinois, 61747, United States

Location

Midwest Center for Hematology Oncology

Joliet, Illinois, 60432, United States

Location

Duly Health and Care Joliet

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

Deerpath Medical Associates

Lake Forest, Illinois, 60045, United States

Location

AMG Libertyville - Oncology

Libertyville, Illinois, 60048, United States

Location

Mcdonough District Hospital

Macomb, Illinois, 61455, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

Location

DuPage Medical Group-Ogden

Naperville, Illinois, 60563, United States

Location

Illinois Cancer Specialists-Niles

Niles, Illinois, 60714, United States

Location

Carle BroMenn Medical Center

Normal, Illinois, 61761, United States

Location

Carle Cancer Institute Normal

Normal, Illinois, 61761, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, 61350, United States

Location

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554, United States

Location

Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Hospital

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

Swedish American Hospital

Rockford, Illinois, 61104, United States

Location

Edward H Kaplan MD and Associates

Skokie, Illinois, 60076, United States

Location

Hematology Oncology Associates of Illinois - Skokie

Skokie, Illinois, 60076, United States

Location

Midwest Cancer Research Group Incorporated

Skokie, Illinois, 60077, United States

Location

Saint Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States

Location

Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, 46845, United States

Location

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, 46360, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

Memorial Hospital of Arkansas City

Arkansas City, Kansas, 67005, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Providence Medical Center

Kansas City, Kansas, 66112, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas - Ottawa

Ottawa, Kansas, 66067, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Radiation Oncology Practice Corporation Southwest

Overland Park, Kansas, 66210, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Kansas City NCI Community Oncology Research Program

Prairie Village, Kansas, 66208, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

AdventHealth Shawnee Mission

Shawnee Mission, Kansas, 66204, United States

Location

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, 66606, United States

Location

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Wichita NCI Community Oncology Research Program

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70806, United States

Location

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

York Hospital

York Village, Maine, 03909, United States

Location

Christiana Care - Union Hospital

Elkton, Maryland, 21921, United States

Location

Unspecified Site

Rockville, Maryland, 20852, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States

Location

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States

Location

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, 49503, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Beacon Kalamazoo

Kalamazoo, Michigan, 49048, United States

Location

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Mercy Health Partners-Hackley Campus

Muskegon, Michigan, 49442, United States

Location

McLaren Cancer Institute-Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States

Location

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Unity Hospital

Fridley, Minnesota, 55432, United States

Location

Hutchinson Area Health Care

Hutchinson, Minnesota, 55350, United States

Location

Meeker County Memorial Hospital

Litchfield, Minnesota, 55355, United States

Location

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States

Location

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Metro Minnesota Community Oncology Research Consortium

Saint Louis Park, Minnesota, 55416, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Saint Joseph's Hospital - Healtheast

Saint Paul, Minnesota, 55102, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379, United States

Location

Ridgeview Medical Center

Waconia, Minnesota, 55387, United States

Location

Fairview Cancer Center - Woodbury

Woodbury, Minnesota, 55125, United States

Location

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125, United States

Location

Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Southeast Missouri Hospital

Cape Girardeau, Missouri, 63701, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Centerpoint Medical Center LLC

Independence, Missouri, 64057, United States

Location

University Health Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Radiation Oncology Practice Corporation South

Kansas City, Missouri, 64114, United States

Location

Saint Joseph Health Center

Kansas City, Missouri, 64114, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Radiation Oncology Practice Corporation - North

Kansas City, Missouri, 64154, United States

Location

Liberty Hospital

Liberty, Missouri, 64068, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

SSM Health Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

Saint Vincent Healthcare

Billings, Montana, 59101, United States

Location

Montana Cancer Consortium NCORP

Billings, Montana, 59102, United States

Location

Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Deaconess Medical Center

Billings, Montana, 59107, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Internal Medicine of Bozeman

Bozeman, Montana, 59715, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Saint Peter's Community Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Logan Health Medical Center

Kalispell, Montana, 59901, United States

Location

Eastern Montana Cancer Center

Miles City, Montana, 59301, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States

Location

Riverview Medical Center/Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, 13057, United States

Location

Adirondack Cancer Center

Glens Falls, New York, 12801, United States

Location

Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

Interlakes Foundation Inc-Rochester

Rochester, New York, 14623, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

State University of New York Upstate Medical University

Syracuse, New York, 13210, United States

Location

Syracuse Veterans Administration Medical Center

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center-Wakefield Campus

The Bronx, New York, 10466, United States

Location

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

ECU Health Oncology Kinston

Kinston, North Carolina, 28501, United States

Location

Lenoir Memorial Hospital

Kinston, North Carolina, 28501, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893, United States

Location

Southeast Clinical Oncology Research Consortium NCORP

Winston-Salem, North Carolina, 27104, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Mary Rutan Hospital

Bellefontaine, Ohio, 43311, United States

Location

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Columbus NCI Community Oncology Research Program

Columbus, Ohio, 43215, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health Center West

Columbus, Ohio, 43222, United States

Location

Doctors Hospital

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Dayton Veterans Affairs Medical Center

Dayton, Ohio, 45428, United States

Location

Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Saint Rita's Medical Center

Lima, Ohio, 45801, United States

Location

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Springfield Regional Medical Center

Springfield, Ohio, 45504, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Saint Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Wright-Patterson Medical Center

Wright-Patterson Air Force Base, Ohio, 45433, United States

Location

Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States

Location

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States

Location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Saint Luke's University Hospital-Bethlehem Campus

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Geisinger Medical Group

State College, Pennsylvania, 16801, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

AnMed Health Hospital

Anderson, South Carolina, 29621, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center

Sioux Falls, South Dakota, 57105, United States

Location

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57117-5045, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

Audie L Murphy VA Hospital

San Antonio, Texas, 78229, United States

Location

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical PLLC

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98112, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States

Location

Saint Michael Cancer Center

Silverdale, Washington, 98383, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

Central Washington Hospital

Wenatchee, Washington, 98801, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701, United States

Location

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481, United States

Location

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Welch Cancer Center

Sheridan, Wyoming, 82801, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Doctor H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Verdun Hospital Centre

Montreal, Quebec, H4G 2A3, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

  • Radich JP, Kopecky KJ, Appelbaum FR, Kamel-Reid S, Stock W, Malnassy G, Paietta E, Wadleigh M, Larson RA, Emanuel P, Tallman M, Lipton J, Turner AR, Deininger M, Druker BJ. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood. 2012 Nov 8;120(19):3898-905. doi: 10.1182/blood-2012-02-410688. Epub 2012 Aug 22.

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

DasatinibImatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazines

Results Point of Contact

Title
SWOG Leukemia Statistician
Organization
SWOG Statistical Office

Study Officials

  • Brian J Druker

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

August 15, 2004

Primary Completion

November 1, 2010

Study Completion (Estimated)

March 10, 2027

Last Updated

May 1, 2026

Results First Posted

July 10, 2012

Record last verified: 2026-02

Locations