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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

Phase 2
18 Years
Open (Enrolling)
Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia

Thank you

Trial Information

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


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

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

VII. Compare, preliminarily, the overall survival and relapse-free survival of patients
treated with these regimens.


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.

Inclusion Criteria


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

- 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]

- 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

- Must be enrolled on SWOG-9007 (SWOG institutions only) and SWOG-S9910

- 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

- Bilirubin no greater than 2.0 times upper limit of normal (ULN)

- AST or ALT no greater than 2.0 times ULN

- 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

- Zubrod 0-2

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other concurrent anticancer biologic agents

- 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

- No concurrent anticancer radiotherapy

- More than 28 days since prior major surgery and recovered

- 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

- Pepridil

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Molecular Response Rate at 12 Months

Outcome Description:

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.

Outcome Time Frame:

pretreatment and after 12 months of treatment

Safety Issue:


Principal Investigator

Brian Druker

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Phase Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase



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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
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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
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Cancer Center of Kansas - Salina Salina, Kansas  67042
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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
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Welch Cancer Center Sheridan, Wyoming  82801
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
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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
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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
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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
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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
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Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
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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
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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
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Singing River Hospital Pascagoula, Mississippi  39581
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Union Hospital of Cecil County Elkton MD, Maryland  21921
Mayo Clinic in Florida Jacksonville, Florida  32224
Memorial Medical Center Springfield, Illinois  62781
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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
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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
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Providence Hospital Southfield, Michigan  48075
Oregon Health and Science University Portland, Oregon  97201
Decatur Memorial Hospital Decatur, Illinois  62526
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Penn State Milton S Hershey Medical Center Hershey, Pennsylvania  17033
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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
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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