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Imatinib Mesylate or Dasatinib in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
This study is ongoing, but not recruiting participants.
First Received: October 3, 2003   Last Updated: May 30, 2009   History of Changes
Sponsor: Southwest Oncology Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070499
  Purpose

RATIONALE: Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This randomized phase II trial is studying 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.


Condition Intervention Phase
Leukemia
Drug: dasatinib
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Molecular response at 12 months [ Designated as safety issue: No ]
  • Hematological response [ Designated as safety issue: No ]
  • Cytogenetic response (complete and partial response) measured on bone marrow at baseline, 6 and 12 months [ Designated as safety issue: No ]
  • Prognostic effects [ Designated as safety issue: No ]
  • Changes in gene expression at pre-treatment and relapse [ Designated as safety issue: No ]
  • Frequency and severity of toxic effects [ Designated as safety issue: Yes ]
  • Overall and relapse-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2004
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
Patients receive oral imatinib mesylate once daily.
Drug: imatinib mesylate
Given orally
Arm II: Experimental
Patients receive oral imatinib mesylate twice daily.
Drug: imatinib mesylate
Given orally
Arm III: Experimental
Patients receive oral dasatinib twice daily.
Drug: dasatinib
Given orally

Detailed Description:

OBJECTIVES:

  • 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.
  • Test whether increasing doese of imatinib mesylate from 400 mg/day to 800 mg/day increases molecular response rate (as measured by decrese in bcr-abl transcript after 12 months of treatment) in these patients.
  • Compare rates of cytogenetic and hematologic response in patients treated with these regimens.
  • Compare, preliminarily, the prognostic effects of der(9) and der(22) chromosomal deletions for response in patients treated with these regimens.
  • Compare, preliminarily, changes in gene expression at pre-treatment vs at relapse or progression in patients treated with these regimens.
  • Compare the frequency and severity of the toxic effects of these regimens in these patients.
  • 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.

Patients are followed for up to 5 years.

PROJECTED ACCRUAL: A total of 335 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic phase chronic myelogenous leukemia (CML) by bone marrow aspiration, biopsy, and peripheral blood counts, meeting criteria for 1 of the following:

    • Philadelphia chromosome-positive* or presence of the variants of the (9;22) translocation by cytogenetics or fluorescent in situ hybridization

      • Secondary chromosomal abnormalities (in addition to the Philadelphia chromosome) allowed
    • bcr-abl positive* by reverse transcription polymerase chain reaction NOTE: *First cytogenetic or molecular analysis performed within the past 180 days to confirm status
  • Must be enrolled on SWOG-9007 (SWOG institutions only) and SWOG-S9910

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • No significant bleeding disorder unrelated to cancer including:

    • Congenital bleeding disorders (e.g., von Willebrand's disease)
    • Acquired bleeding disorder within the past year (e.g., acquired anti-factor VIII antibodies)

Hepatic

  • Bilirubin no greater than 2.0 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.0 times ULN

Renal

  • Not specified

Cardiovascular

  • No cardiac symptoms including any of the following:

    • Uncontrolled angina
    • Congestive heart failure or myocardial infarction within the past 6 months
    • Diagnosed or suspected congenital long QT syndrome
    • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
    • Prolonged QTc interval on electrocardiogram (> 450 msec)
    • Uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent anticancer biologic agents

Chemotherapy

  • No prior chemotherapy for peripheral blood stem cell mobilization

    • Prior collection of unmobilized peripheral blood stem cells allowed
  • No other concurrent anticancer chemotherapy

    • Concurrent hydroxyurea and/or anagrelide to control blood counts allowed provided it is only administered during the first 28 days of study therapy and for no more than 28 additional days after study therapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent anticancer radiotherapy

Surgery

  • More than 28 days since prior major surgery and recovered

Other

  • No prior treatment for CML (except hydroxyurea and/or anagrelide)
  • No concurrent therapeutic anticoagulation with warfarin

    • Concurrent therapeutic anticoagulation with low-molecular weight heparin allowed
    • Concurrent low-dose warfarin for prophylaxis to prevent catheter thrombosis allowed (arm III only)
  • No concurrent drugs* that have a risk of causing Torsades de Pointe including (arm III patients only):

    • Quinidine, procainamide, disopyramide
    • Amiodarone, sotalol, ibutilide, dofetilide
    • Erythromycin, clarithromycin
    • Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
    • Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone
    • Halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine NOTE: *Patients who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug prior to first dose of dasatinib
  • No concurrent drugs that irreversibly inhibit platelet function, including any of the following (arm III only):

    • Aspirin

      • Patients who have discontinued aspirin must have a wash-out period of at least 7 days for low-dose aspirin (< 325 mg/day) or 14 days for high-dose aspirin (> 325 mg/day) prior to first dose of dasatinib
    • Dipyridamole
    • Epoprostenol
    • Eptifibatide
    • Clopidogrel
    • Cilostazol
    • Abciximab
    • Ticlopidine
  • No other concurrent anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070499

  Hide Study Locations
Locations
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
United States, Florida
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
La Grange Oncology Associates - Geneva
Naperville, Illinois, United States, 60563
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Graham Hospital
Canton, Illinois, United States, 61520
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Community Cancer Center
Normal, Illinois, United States, 61761
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46815
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
Southwest Medical Center
Liberal, Kansas, United States, 67901
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Maine
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
York Hospital's Oncology Treatment Center
York, Maine, United States, 03909
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. John Macomb Hospital
Warren, Michigan, United States, 48093
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
United Hospital
Saint Paul, Minnesota, United States, 55102
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Independence Regional Health Center
Independence, Missouri, United States, 64050
Midwest Hematology Oncology Group, Incorporated
Saint Louis, Missouri, United States, 63109
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
CCOP - Columbus
Columbus, Ohio, United States, 43215
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Mercy Medical Center
Springfield, Ohio, United States, 45504
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States, 44903
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Kaiser Permanente Health Care - Portland
Portland, Oregon, United States, 97232
United States, Pennsylvania
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Polyclinic First Hill
Seattle, Washington, United States, 98122
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Harborview Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States, 54481
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
Investigator: Brian J. Druker, MD OHSU Knight Cancer Institute
Investigator: Marilyn L. Slovak, PhD Beckman Research Institute
Investigator: Peter D. Emanuel, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers: CDR0000334588, SWOG-S0325, ECOG-S0325
Study First Received: October 3, 2003
Last Updated: May 30, 2009
ClinicalTrials.gov Identifier: NCT00070499     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009