Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
Chronic Myeloid Leukemia, BCR-ABL1 Positive
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia, BCR-ABL1 Positive
Eligibility Criteria
Inclusion Criteria: 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 Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec) Uncontrolled hypertension Patients must not have a history of significant bleeding disorder unrelated to cancer, including: Congenital bleeding disorders (e.g., von Willebrand's disease) Acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
Sites / Locations
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- City of Hope Comprehensive Cancer Center
- Kaiser Permanente-Fremont
- USC / Norris Comprehensive Cancer Center
- Kaiser Permanente-Oakland
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Rocky Mountain Regional VA Medical Center
- University of Colorado
- Poudre Valley Hospital
- Montrose Memorial Hospital
- SCL Health Lutheran Medical Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Saint Francis Hospital - Wilmington
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Orlando Health Cancer Institute
- Moffitt Cancer Center
- Saint Anthony's Health
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Hematology and Oncology Associates
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- University of Illinois
- Mercy Hospital and Medical Center
- Swedish Covenant Hospital
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Midwest Center for Hematology Oncology
- Duly Health and Care Joliet
- Kewanee Hospital
- Deerpath Medical Associates
- AMG Libertyville - Oncology
- Mcdonough District Hospital
- Loyola University Medical Center
- Good Samaritan Regional Health Center
- DuPage Medical Group-Ogden
- Illinois Cancer Specialists-Niles
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Valley Radiation Oncology
- Perry Memorial Hospital
- Swedish American Hospital
- Edward H Kaplan MD and Associates
- Hematology Oncology Associates of Illinois - Skokie
- Midwest Cancer Research Group Incorporated
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Franciscan Saint Francis Health-Beech Grove
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Franciscan Saint Anthony Health-Michigan City
- Reid Health
- McFarland Clinic - Ames
- Memorial Hospital of Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas-Independence
- Providence Medical Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Ottawa
- Menorah Medical Center
- Radiation Oncology Practice Corporation Southwest
- Cancer Center of Kansas - Parsons
- Kansas City NCI Community Oncology Research Program
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Salina Regional Health Center
- Advent Health - Shawnee Mission Medical Center
- Cotton O'Neil Cancer Center / Stormont Vail Health
- University of Kansas Health System Saint Francis Campus
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Baton Rouge General Medical Center
- Mary Bird Perkins Cancer Center
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Eastern Maine Medical Center
- York Hospital
- Christiana Care - Union Hospital
- Unspecified Site
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital - Dearborn
- Henry Ford Hospital
- Ascension Saint John Hospital
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Holland Community Hospital
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Mercy Health Partners-Hackley Campus
- McLaren Cancer Institute-Northern Michigan
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- Ascension Saint Mary's Hospital
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- University of Michigan Health - West
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology PA-Woodbury
- Woodwinds Health Campus
- Singing River Hospital
- Southeast Missouri Hospital
- Saint Francis Medical Center
- Missouri Cancer Associates
- Centerpoint Medical Center LLC
- Truman Medical Centers
- Saint Luke's Hospital of Kansas City
- Radiation Oncology Practice Corporation South
- Saint Joseph Health Center
- North Kansas City Hospital
- Research Medical Center
- Radiation Oncology Practice Corporation - North
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- SSM Health Saint Louis University Hospital
- Saint Louis Cancer and Breast Institute-South City
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Hospital
- Internal Medicine of Bozeman
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Eastern Montana Cancer Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Guardian Oncology and Center for Wellness
- Cooper Hospital University Medical Center
- Riverview Medical Center/Booker Cancer Center
- University of New Mexico Cancer Center
- Montefiore Medical Center-Wakefield Campus
- Mary Imogene Bassett Hospital
- Hematology Oncology Associates of Central New York-East Syracuse
- Adirondack Cancer Center
- Glens Falls Hospital
- Interlakes Foundation Inc-Rochester
- University of Rochester
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Syracuse Veterans Administration Medical Center
- Carolinas Medical Center/Levine Cancer Institute
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Lenoir Memorial Hospital
- Vidant Oncology-Kinston
- Rutherford Hospital
- Iredell Memorial Hospital
- Wilson Medical Center
- Southeast Clinical Oncology Research Consortium NCORP
- Wake Forest University Health Sciences
- Mary Rutan Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton Veterans Affairs Medical Center
- Dayton NCI Community Oncology Research Program
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- Licking Memorial Hospital
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Wright-Patterson Medical Center
- Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Genesis Healthcare System Cancer Care Center
- Natalie Warren Bryant Cancer Center at Saint Francis
- Kaiser Permanente Northwest
- Oregon Health and Science University
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Penn State Milton S Hershey Medical Center
- Lewistown Hospital
- Jefferson Torresdale Hospital
- West Penn Hospital
- Geisinger Medical Group
- Mount Nittany Medical Center
- Geisinger Wyoming Valley/Henry Cancer Center
- AnMed Health Hospital
- Medical University of South Carolina
- McLeod Regional Medical Center
- Spartanburg Medical Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Medical X-Ray Center
- Avera McKennan Hospital and University Health Center
- Sanford USD Medical Center - Sioux Falls
- Brooke Army Medical Center
- Wilford Hall Medical Center
- Audie L Murphy VA Hospital
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University Hospital
- University of Texas Health Science Center at San Antonio
- Huntsman Cancer Institute/University of Utah
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Kadlec Clinic Hematology and Oncology
- Skagit Valley Hospital
- Harborview Medical Center
- Minor and James Medical PLLC
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Montlake
- PeaceHealth United General Medical Center
- Cancer Care Northwest - Spokane South
- PeaceHealth Southwest Medical Center
- Central Washington Hospital
- Wenatchee Valley Hospital and Clinics
- West Virginia University Healthcare
- HSHS Sacred Heart Hospital
- Marshfield Clinic Cancer Center at Sacred Heart
- Gundersen Lutheran Medical Center
- Marshfield Medical Center-Marshfield
- Marshfield Medical Center
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Ascension Saint Michael's Hospital
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Welch Cancer Center
- Cross Cancer Institute
- CancerCare Manitoba
- The Moncton Hospital
- Doctor H. Bliss Murphy Cancer Centre
- QEII Health Sciences Centre/Nova Scotia Health Authority
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- University Health Network-Princess Margaret Hospital
- Verdun Hospital Centre
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (QD imatinib mesylate)
Arm II (BID imatinib mesylate)
Arm III (dasatinib)
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.
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.
Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.