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Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00070499
Collaborator
(none)
406
Enrollment
341
Locations
3
Arms
1.2
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dasatinib
  • Drug: Imatinib Mesylate
  • Other: Laboratory Biomarker Analysis
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:

  1. To compare the molecular response rates, as measured by the decrease in breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) transcripts after 12 months of treatment, in patients with previously untreated chronic myelogenous leukemia (CML) in chronic phase who are treated with either dasatinib 100 mg/day or imatinib (STI571, Gleevec) (imatinib mesylate) 400 mg/day.

  2. To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase.

  3. To estimate rates of cytogenetic and hematologic responses to imatinib 400 mg/day, imatinib 800 mg/day, and dasatinib 100 mg/day.

  4. To evaluate in a preliminary manner the prognostic effects of derivative (der)(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib and dasatinib.

  5. To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment.

  6. To estimate the frequency and severity of toxicities of the three treatment regimens.

  7. To evaluate, in a preliminary manner, the overall survival and relapse-free survival of patients treated with these regimens.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive imatinib mesylate orally (PO) once daily (QD). Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive imatinib mesylate PO twice daily (BID). Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

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

After completion of study treatment, patients are followed up for 15 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
406 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase IIb Study of Molecular Responses to Imatinib, at Standard or Increased Doses, or Dasatinib (BMS-354825) (NSC-732517) for Previously Untreated Patients With Chronic Myelogenous Leukemia (CML) in Chronic Phase
Actual Study Start Date :
Aug 15, 2004
Actual Primary Completion Date :
Nov 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (QD imatinib mesylate)

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 Mesylate
Given PO
Other Names:
  • CGP 57148
  • CGP57148B
  • Gleevec
  • Glivec
  • STI 571
  • STI-571
  • STI571

    • Other: Laboratory Biomarker Analysis
    Correlative studies
    Experimental: Arm II (BID imatinib mesylate)

    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 Mesylate
    Given PO
    Other Names:
  • CGP 57148
  • CGP57148B
  • Gleevec
  • Glivec
  • STI 571
  • STI-571
  • STI571

    • Other: Laboratory Biomarker Analysis
    Correlative studies
    Experimental: Arm III (dasatinib)

    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: Dasatinib
    Given PO
    Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Molecular Response Rate at 12 Months [pretreatment and after 12 months of treatment]

      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.

    Secondary Outcome Measures

    1. Hematologic Response [1 month after starting treatment]

      Hematologic response assesses whether patients' blood counts return to normal

    2. 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]

      Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.

    3. 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]

      Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.

    4. 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.]

      Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    2 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    3 Kaiser Permanente-Fremont Fremont California United States 94538
    4 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    5 Kaiser Permanente-Oakland Oakland California United States 94611
    6 Kaiser Permanente-Redwood City Redwood City California United States 94063
    7 Kaiser Permanente-Richmond Richmond California United States 94801
    8 Kaiser Permanente-Roseville Roseville California United States 95661
    9 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    10 Kaiser Permanente - Sacramento Sacramento California United States 95825
    11 Kaiser Permanente-San Francisco San Francisco California United States 94115
    12 Kaiser Permanente-Santa Teresa-San Jose San Jose California United States 95119
    13 Kaiser Permanente San Leandro San Leandro California United States 94577
    14 Kaiser Permanente-San Rafael San Rafael California United States 94903
    15 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051
    16 Kaiser Permanente-Santa Rosa Santa Rosa California United States 95403
    17 Kaiser Permanente-South San Francisco South San Francisco California United States 94080
    18 Kaiser Permanente-Stockton Stockton California United States 95210
    19 Kaiser Permanente-Vallejo Vallejo California United States 94589
    20 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    21 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    22 University of Colorado Denver Colorado United States 80217-3364
    23 Poudre Valley Hospital Fort Collins Colorado United States 80524
    24 Montrose Memorial Hospital Montrose Colorado United States 81401
    25 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    26 Beebe Medical Center Lewes Delaware United States 19958
    27 Christiana Care Health System-Christiana Hospital Newark Delaware United States 19718
    28 Saint Francis Hospital - Wilmington Wilmington Delaware United States 19805
    29 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    30 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    31 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    32 Orlando Health Cancer Institute Orlando Florida United States 32806
    33 Moffitt Cancer Center Tampa Florida United States 33612
    34 Saint Anthony's Health Alton Illinois United States 62002
    35 Rush - Copley Medical Center Aurora Illinois United States 60504
    36 Saint Joseph Medical Center Bloomington Illinois United States 61701
    37 Graham Hospital Association Canton Illinois United States 61520
    38 Memorial Hospital Carthage Illinois United States 62321
    39 Hematology and Oncology Associates Chicago Illinois United States 60611
    40 Northwestern University Chicago Illinois United States 60611
    41 Jesse Brown Veterans Affairs Medical Center Chicago Illinois United States 60612
    42 University of Illinois Chicago Illinois United States 60612
    43 Mercy Hospital and Medical Center Chicago Illinois United States 60616
    44 Swedish Covenant Hospital Chicago Illinois United States 60625
    45 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    46 Decatur Memorial Hospital Decatur Illinois United States 62526
    47 Heartland Cancer Research NCORP Decatur Illinois United States 62526
    48 Eureka Hospital Eureka Illinois United States 61530
    49 Galesburg Cottage Hospital Galesburg Illinois United States 61401
    50 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    51 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    52 Mason District Hospital Havana Illinois United States 62644
    53 Hopedale Medical Complex - Hospital Hopedale Illinois United States 61747
    54 Midwest Center for Hematology Oncology Joliet Illinois United States 60432
    55 Duly Health and Care Joliet Joliet Illinois United States 60435
    56 Kewanee Hospital Kewanee Illinois United States 61443
    57 Deerpath Medical Associates Lake Forest Illinois United States 60045
    58 AMG Libertyville - Oncology Libertyville Illinois United States 60048
    59 Mcdonough District Hospital Macomb Illinois United States 61455
    60 Loyola University Medical Center Maywood Illinois United States 60153
    61 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    62 DuPage Medical Group-Ogden Naperville Illinois United States 60563
    63 Illinois Cancer Specialists-Niles Niles Illinois United States 60714
    64 Bromenn Regional Medical Center Normal Illinois United States 61761
    65 Carle Cancer Institute Normal Normal Illinois United States 61761
    66 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    67 Ottawa Regional Hospital and Healthcare Center Ottawa Illinois United States 61350
    68 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    69 Pekin Hospital Pekin Illinois United States 61554
    70 Proctor Hospital Peoria Illinois United States 61614
    71 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    72 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    73 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    74 Illinois Valley Hospital Peru Illinois United States 61354
    75 Valley Radiation Oncology Peru Illinois United States 61354
    76 Perry Memorial Hospital Princeton Illinois United States 61356
    77 Swedish American Hospital Rockford Illinois United States 61104
    78 Edward H Kaplan MD and Associates Skokie Illinois United States 60076
    79 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois United States 60076
    80 Midwest Cancer Research Group Incorporated Skokie Illinois United States 60077
    81 Saint Margaret's Hospital Spring Valley Illinois United States 61362
    82 Memorial Medical Center Springfield Illinois United States 62781
    83 Carle Cancer Center Urbana Illinois United States 61801
    84 Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana United States 46107
    85 Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana United States 46845
    86 Franciscan Saint Anthony Health-Michigan City Michigan City Indiana United States 46360
    87 Reid Health Richmond Indiana United States 47374
    88 McFarland Clinic PC - Ames Ames Iowa United States 50010
    89 Memorial Hospital of Arkansas City Arkansas City Kansas United States 67005
    90 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    91 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    92 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    93 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    94 Providence Medical Center Kansas City Kansas United States 66112
    95 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    96 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    97 Southwest Medical Center Liberal Kansas United States 67901
    98 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    99 Cancer Center of Kansas - Ottawa Ottawa Kansas United States 66067
    100 Menorah Medical Center Overland Park Kansas United States 66209
    101 Radiation Oncology Practice Corporation Southwest Overland Park Kansas United States 66210
    102 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    103 Kansas City NCI Community Oncology Research Program Prairie Village Kansas United States 66208
    104 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    105 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    106 Salina Regional Health Center Salina Kansas United States 67401
    107 Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    108 Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas United States 66606
    109 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    110 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    111 Associates In Womens Health Wichita Kansas United States 67208
    112 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    113 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    114 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    115 Wichita NCI Community Oncology Research Program Wichita Kansas United States 67214
    116 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    117 Baton Rouge General Medical Center Baton Rouge Louisiana United States 70806
    118 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    119 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    120 University Medical Center New Orleans New Orleans Louisiana United States 70112
    121 Eastern Maine Medical Center Bangor Maine United States 04401
    122 York Hospital York Maine United States 03909
    123 Christiana Care - Union Hospital Elkton Maryland United States 21921
    124 Unspecified Site Rockville Maryland United States 20852
    125 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    126 Brigham and Women's Hospital Boston Massachusetts United States 02115
    127 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    128 Michigan Cancer Research Consortium NCORP Ann Arbor Michigan United States 48106
    129 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    130 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    131 Bronson Battle Creek Battle Creek Michigan United States 49017
    132 Spectrum Health Big Rapids Hospital Big Rapids Michigan United States 49307
    133 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    134 Henry Ford Hospital Detroit Michigan United States 48202
    135 Ascension Saint John Hospital Detroit Michigan United States 48236
    136 Hurley Medical Center Flint Michigan United States 48503
    137 Genesys Regional Medical Center-West Flint Campus Flint Michigan United States 48532
    138 Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan United States 49503
    139 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    140 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    141 Holland Community Hospital Holland Michigan United States 49423
    142 Allegiance Health Jackson Michigan United States 49201
    143 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    144 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    145 Borgess Medical Center Kalamazoo Michigan United States 49048
    146 Sparrow Hospital Lansing Michigan United States 48912
    147 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    148 Mercy Health Partners-Hackley Campus Muskegon Michigan United States 49442
    149 McLaren Cancer Institute-Northern Michigan Petoskey Michigan United States 49770
    150 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
    151 Lake Huron Medical Center Port Huron Michigan United States 48060
    152 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    153 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    154 Munson Medical Center Traverse City Michigan United States 49684
    155 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    156 Metro Health Hospital Wyoming Michigan United States 49519
    157 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    158 Mercy Hospital Coon Rapids Minnesota United States 55433
    159 Fairview Southdale Hospital Edina Minnesota United States 55435
    160 Unity Hospital Fridley Minnesota United States 55432
    161 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
    162 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
    163 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    164 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    165 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    166 Virginia Piper Cancer Institute Minneapolis Minnesota United States 55407
    167 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    168 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    169 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    170 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    171 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    172 Regions Hospital Saint Paul Minnesota United States 55101
    173 Saint Joseph's Hospital - Healtheast Saint Paul Minnesota United States 55102
    174 United Hospital Saint Paul Minnesota United States 55102
    175 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    176 Ridgeview Medical Center Waconia Minnesota United States 55387
    177 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    178 Woodwinds Health Campus Woodbury Minnesota United States 55125
    179 Singing River Hospital Pascagoula Mississippi United States 39581
    180 Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    181 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    182 Missouri Cancer Associates Columbia Missouri United States 65201
    183 Centerpoint Medical Center LLC Independence Missouri United States 64057
    184 Truman Medical Centers Kansas City Missouri United States 64108
    185 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
    186 Radiation Oncology Practice Corporation South Kansas City Missouri United States 64114
    187 Saint Joseph Health Center Kansas City Missouri United States 64114
    188 North Kansas City Hospital Kansas City Missouri United States 64116
    189 Research Medical Center Kansas City Missouri United States 64132
    190 Radiation Oncology Practice Corporation - North Kansas City Missouri United States 64154
    191 Liberty Radiation Oncology Center Liberty Missouri United States 64068
    192 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    193 SSM Health Saint Louis University Hospital Saint Louis Missouri United States 63104
    194 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    195 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    196 Saint Louis-Cape Girardeau CCOP Saint Louis Missouri United States 63141
    197 Billings Clinic Cancer Center Billings Montana United States 59101
    198 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    199 Saint Vincent Healthcare Billings Montana United States 59101
    200 Montana Cancer Consortium NCORP Billings Montana United States 59102
    201 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    202 Deaconess Medical Center Billings Montana United States 59107
    203 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    204 Internal Medicine of Bozeman Bozeman Montana United States 59715
    205 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    206 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    207 Berdeaux, Donald MD (UIA Investigator) Great Falls Montana United States 59405
    208 Great Falls Clinic Great Falls Montana United States 59405
    209 Saint Peter's Community Hospital Helena Montana United States 59601
    210 Glacier Oncology PLLC Kalispell Montana United States 59901
    211 Kalispell Medical Oncology Kalispell Montana United States 59901
    212 Kalispell Regional Medical Center Kalispell Montana United States 59901
    213 Eastern Montana Cancer Center Miles City Montana United States 59301
    214 Montana Cancer Specialists Missoula Montana United States 59802
    215 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    216 Community Medical Hospital Missoula Montana United States 59804
    217 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    218 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    219 Riverview Medical Center/Booker Cancer Center Red Bank New Jersey United States 07701
    220 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    221 Montefiore Medical Center-Wakefield Campus Bronx New York United States 10466
    222 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    223 Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York United States 13057
    224 Adirondack Cancer Center Glens Falls New York United States 12801
    225 Glens Falls Hospital Glens Falls New York United States 12801
    226 Interlakes Foundation Inc-Rochester Rochester New York United States 14623
    227 University of Rochester Rochester New York United States 14642
    228 Stony Brook University Medical Center Stony Brook New York United States 11794
    229 State University of New York Upstate Medical University Syracuse New York United States 13210
    230 Syracuse Veterans Administration Medical Center Syracuse New York United States 13210
    231 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    232 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
    233 Wayne Radiation Oncology Goldsboro North Carolina United States 27534
    234 Lenoir Memorial Hospital Kinston North Carolina United States 28501
    235 Vidant Oncology-Kinston Kinston North Carolina United States 28501
    236 Rutherford Hospital Rutherfordton North Carolina United States 28139
    237 Iredell Memorial Hospital Statesville North Carolina United States 28677
    238 Wilson Medical Center Wilson North Carolina United States 27893
    239 Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina United States 27104
    240 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    241 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    242 Aultman Health Foundation Canton Ohio United States 44710
    243 Adena Regional Medical Center Chillicothe Ohio United States 45601
    244 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    245 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    246 Riverside Methodist Hospital Columbus Ohio United States 43214
    247 Columbus NCI Community Oncology Research Program Columbus Ohio United States 43215
    248 Grant Medical Center Columbus Ohio United States 43215
    249 Mount Carmel Health Center West Columbus Ohio United States 43222
    250 Doctors Hospital Columbus Ohio United States 43228
    251 Grandview Hospital Dayton Ohio United States 45405
    252 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
    253 Miami Valley Hospital Dayton Ohio United States 45409
    254 Miami Valley Hospital North Dayton Ohio United States 45415
    255 Dayton Veterans Affairs Medical Center Dayton Ohio United States 45428
    256 Dayton NCI Community Oncology Research Program Dayton Ohio United States 45459
    257 Grady Memorial Hospital Delaware Ohio United States 43015
    258 Blanchard Valley Hospital Findlay Ohio United States 45840
    259 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    260 Kettering Medical Center Kettering Ohio United States 45429
    261 Fairfield Medical Center Lancaster Ohio United States 43130
    262 Saint Rita's Medical Center Lima Ohio United States 45801
    263 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    264 Marietta Memorial Hospital Marietta Ohio United States 45750
    265 Licking Memorial Hospital Newark Ohio United States 43055
    266 Springfield Regional Medical Center Springfield Ohio United States 45505
    267 Upper Valley Medical Center Troy Ohio United States 45373
    268 Saint Ann's Hospital Westerville Ohio United States 43081
    269 Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio United States 45433
    270 Greene Memorial Hospital Xenia Ohio United States 45385
    271 Tod Children's Hospital - Forum Health Youngstown Ohio United States 44501
    272 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    273 Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma United States 74136
    274 Kaiser Permanente Northwest Portland Oregon United States 97227
    275 Oregon Health and Science University Portland Oregon United States 97239
    276 Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania United States 18015
    277 Geisinger Medical Center Danville Pennsylvania United States 17822
    278 Penn State Milton S Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    279 Lewistown Hospital Lewistown Pennsylvania United States 17044
    280 Jefferson Torresdale Hospital Philadelphia Pennsylvania United States 19114
    281 West Penn Hospital Pittsburgh Pennsylvania United States 15224
    282 Geisinger Medical Group State College Pennsylvania United States 16801
    283 Mount Nittany Medical Center State College Pennsylvania United States 16803
    284 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    285 AnMed Health Hospital Anderson South Carolina United States 29621
    286 Medical University of South Carolina Charleston South Carolina United States 29425
    287 McLeod Regional Medical Center Florence South Carolina United States 29506
    288 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    289 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    290 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    291 Medical X-Ray Center Sioux Falls South Dakota United States 57105
    292 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57117-5045
    293 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    294 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    295 Wilford Hall Medical Center Lackland Air Force Base Texas United States 78236
    296 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    297 Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas United States 78229
    298 University Hospital San Antonio Texas United States 78229
    299 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    300 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    301 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    302 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    303 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    304 Skagit Valley Hospital Mount Vernon Washington United States 98274
    305 Harborview Medical Center Seattle Washington United States 98104
    306 Minor and James Medical PLLC Seattle Washington United States 98104
    307 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    308 Kaiser Permanente Washington Seattle Washington United States 98112
    309 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    310 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    311 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    312 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    313 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    314 Central Washington Hospital Wenatchee Washington United States 98801
    315 Wenatchee Valley Hospital and Clinics Wenatchee Washington United States 98801
    316 West Virginia University Healthcare Morgantown West Virginia United States 26506
    317 HSHS Sacred Heart Hospital Eau Claire Wisconsin United States 54701
    318 Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin United States 54701
    319 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    320 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    321 Marshfield Medical Center Marshfield Wisconsin United States 54449
    322 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    323 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    324 Ascension Saint Mary's Hospital Rhinelander Wisconsin United States 54501
    325 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    326 Ascension Saint Michael's Hospital Stevens Point Wisconsin United States 54481
    327 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    328 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    329 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    330 Welch Cancer Center Sheridan Wyoming United States 82801
    331 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    332 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    333 The Moncton Hospital Moncton New Brunswick Canada E1C 6Z8
    334 Doctor H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador Canada A1B 3V6
    335 QEII Health Sciences Centre/Nova Scotia Health Authority Halifax Nova Scotia Canada B3H 2Y9
    336 Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario Canada L8V 5C2
    337 London Regional Cancer Program London Ontario Canada N6A 4L6
    338 University Health Network-Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    339 Verdun Hospital Centre Montreal Quebec Canada H4G 2A3
    340 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    341 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brian J Druker, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00070499
    Other Study ID Numbers:
    • NCI-2009-00764
    • NCI-2009-00764
    • S0325
    • S0325
    • S0325
    • U10CA180888
    • U10CA032102
    First Posted:
    Oct 7, 2003
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Imatinib Mesylate
    Dasatinib

    Study Results

    Participant Flow

    Recruitment Details Note that 403 patients were registered to the study. Three patients were registered to standard dose imatinib while concurrent randomization was occurring between standard dose imatinib, high dose imatinib, and dasatinib. Those three patients are included in both the standard dose imatinib A and B cohorts.
    Pre-assignment Detail
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily. High dose imatinib was 800 mg daily. Dasatinib dose was 100 mg daily Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
    Period Title: Overall Study
    STARTED 75 78 126 127
    Eligible 73 73 123 125
    Eligible and Treated 72 73 123 123
    COMPLETED 37 52 6 17
    NOT COMPLETED 38 26 120 110

    Baseline Characteristics

    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B Total
    Arm/Group Description Randomization between occurred between standard dose imatinib A and high dose imatinib Randomization occurred between Standard dose imatinib and dasatinib Total of all reporting groups
    Overall Participants 72 73 123 123 391
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    50
    52
    47
    50
    50
    Sex: Female, Male (Count of Participants)
    Female
    26
    36.1%
    26
    35.6%
    48
    39%
    51
    41.5%
    151
    38.6%
    Male
    46
    63.9%
    47
    64.4%
    75
    61%
    72
    58.5%
    240
    61.4%
    Region of Enrollment (participants) [Number]
    United States
    72
    100%
    73
    100%
    123
    100%
    123
    100%
    391
    100%

    Outcome Measures

    1. Primary Outcome
    Title Molecular Response Rate at 12 Months
    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.
    Time Frame pretreatment and after 12 months of treatment

    Outcome Measure Data

    Analysis Population Description
    Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Standard dose imatinib A High dose imatinib Dasatinib Standard dose imatinib B
    Measure Participants 49 55 99 90
    Number [participants]
    5
    6.9%
    14
    19.2%
    27
    22%
    18
    14.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Dose Imatinib A, High Dose Imatinib
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.073
    Comments
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dasatinib, Standard Dose Imatinib B
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.31
    Comments
    Method Fisher Exact
    Comments
    2. Secondary Outcome
    Title Hematologic Response
    Description Hematologic response assesses whether patients' blood counts return to normal
    Time Frame 1 month after starting treatment

    Outcome Measure Data

    Analysis Population Description
    Eligible, treated patients who were evaluable for hematologic response
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization between occurred between standard dose imatinib A and high dose imatinib Randomization occurred between Standard dose imatinib and dasatinib
    Measure Participants 72 72 123 123
    Number [participants]
    63
    87.5%
    66
    90.4%
    107
    87%
    112
    91.1%
    3. Secondary Outcome
    Title 2-year Overall Survival (OS)
    Description Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
    Time Frame Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5

    Outcome Measure Data

    Analysis Population Description
    All eligible patients who were treated
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization between occurred between standard dose imatinib A and high dose imatinib Randomization occurred between Standard dose imatinib and dasatinib
    Measure Participants 72 73 123 123
    Number [Percent of population]
    89
    95
    97
    98
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Dose Imatinib A, High Dose Imatinib
    Comments Log-rank test of overall survival
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.29
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dasatinib, Standard Dose Imatinib B
    Comments Log-rank test of overall survival
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.55
    Comments
    Method Log Rank
    Comments
    4. Secondary Outcome
    Title Two Year Relapse-free Survival
    Description Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.
    Time Frame every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5

    Outcome Measure Data

    Analysis Population Description
    Eligible, treated patients who achieved a hematologic complete remission
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization between occurred between standard dose imatinib A and high dose imatinib Randomization occurred between Standard dose imatinib and dasatinib
    Measure Participants 63 66 107 112
    Number [Percent of population]
    83
    97
    96
    95
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Standard Dose Imatinib A, High Dose Imatinib
    Comments Log-rank test of relapse-free survival
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.074
    Comments
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Dasatinib, Standard Dose Imatinib B
    Comments Log-rank test of relapse-free survival
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value 0.29
    Comments
    Method Log Rank
    Comments
    5. Secondary Outcome
    Title Toxicity
    Description Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
    Time Frame 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.

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who started therapy
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily Patients received 800 mg imatinib daily Patients received 100 mg dasatinib daily Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
    Measure Participants 72 72 122 123
    ALT, SGPT (serum glutamic pyruvic transaminase)
    1
    1.4%
    3
    4.1%
    1
    0.8%
    3
    2.4%
    AST, SGOT (serum glutamic oxaloacetic trans.)
    1
    1.4%
    1
    1.4%
    1
    0.8%
    2
    1.6%
    Bilirubin (hyperbilirubinemia)
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    Bronchospasm, wheezing
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    CNS cerebrovascular ischemia
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    CPK (creatine phosphokinase)
    3
    4.2%
    0
    0%
    1
    0.8%
    0
    0%
    Cardiac-ischemia/infarction
    0
    0%
    0
    0%
    2
    1.6%
    0
    0%
    Colitis
    0
    0%
    0
    0%
    3
    2.4%
    0
    0%
    Conduction abnor/Atrioventricular heart block
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Constipation
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Dehydration
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Diarrhea
    1
    1.4%
    6
    8.2%
    6
    4.9%
    2
    1.6%
    Distention/bloating, abdominal
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Dizziness
    1
    1.4%
    0
    0%
    0
    0%
    1
    0.8%
    Dyspnea (shortness of breath)
    0
    0%
    2
    2.7%
    7
    5.7%
    2
    1.6%
    Edema: head and neck
    2
    2.8%
    0
    0%
    0
    0%
    2
    1.6%
    Edema: limb
    0
    0%
    2
    2.7%
    1
    0.8%
    1
    0.8%
    Edema: trunk/genital
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Edema: viscera
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    Fatigue (asthenia, lethargy, malaise)
    0
    0%
    11
    15.1%
    1
    0.8%
    1
    0.8%
    Febrile neutropenia
    1
    1.4%
    1
    1.4%
    3
    2.4%
    0
    0%
    GGT (gamma-glutamyl transpeptidase)
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Glucose, serum-high (hyperglycemia)
    0
    0%
    0
    0%
    3
    2.4%
    0
    0%
    Hematoma
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Hemoglobin
    5
    6.9%
    8
    11%
    12
    9.8%
    5
    4.1%
    Hepatobiliary/Pancreas-Other (Specify)
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Hot flashes/flushes
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Hypertension
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Hypoxia
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Infection with Grade 3 or 4 neutrophils - Blood
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Infection with Grade 3/4 neut - Lung (pneumon
    0
    0%
    0
    0%
    2
    1.6%
    0
    0%
    Infec with norm ANC or Grade 1 or 2 neut - Colon
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Inf with no ANC or Grade 1/2 netLung (pneumonia)
    0
    0%
    1
    1.4%
    2
    1.6%
    0
    0%
    Infec with norm ANC or Grade 1 or 2 neut - Scrotum
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Infect with norm ANC or Grade 1 or 2 neut - Sinus
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Inf with no ANC or Grade 1/2 neut - Ur tract NOS
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    Infection with unknown ANC - Sinus
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Left ventricular diastolic dysfunction
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Leukocytes (total WBC)
    1
    1.4%
    2
    2.7%
    3
    2.4%
    3
    2.4%
    Lymphopenia
    1
    1.4%
    1
    1.4%
    3
    2.4%
    1
    0.8%
    Metabolic/Laboratory-Other (Specify)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Mood alteration - depression
    1
    1.4%
    0
    0%
    0
    0%
    0
    0%
    Mucositis/stomatitis (clinical exam) - Oral cavity
    0
    0%
    0
    0%
    0
    0%
    2
    1.6%
    Muscle weak, not due to neurop. Whole body/general
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Nausea
    2
    2.8%
    2
    2.7%
    0
    0%
    1
    0.8%
    Neuropathy: motor
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Neuropathy: sensory
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Neutrophils/granulocytes (ANC/AGC)
    8
    11.1%
    12
    16.4%
    18
    14.6%
    15
    12.2%
    Pain - Abdomen NOS
    1
    1.4%
    4
    5.5%
    3
    2.4%
    1
    0.8%
    Pain - Back
    0
    0%
    1
    1.4%
    0
    0%
    1
    0.8%
    Pain - Bone
    1
    1.4%
    3
    4.1%
    2
    1.6%
    0
    0%
    Pain - Chest/thorax NOS
    0
    0%
    1
    1.4%
    1
    0.8%
    1
    0.8%
    Pain - Extremity-limb
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Pain - Head/headache
    1
    1.4%
    1
    1.4%
    3
    2.4%
    3
    2.4%
    Pain - Joint
    0
    0%
    1
    1.4%
    1
    0.8%
    2
    1.6%
    Pain - Muscle
    1
    1.4%
    3
    4.1%
    0
    0%
    1
    0.8%
    Pain-Other (Specify)
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Pericardial effusion (non-malignant)
    0
    0%
    0
    0%
    3
    2.4%
    0
    0%
    Phosphate, serum-low (hypophosphatemia)
    0
    0%
    0
    0%
    1
    0.8%
    1
    0.8%
    Platelets
    6
    8.3%
    14
    19.2%
    22
    17.9%
    11
    8.9%
    Pleural effusion (non-malignant)
    0
    0%
    0
    0%
    4
    3.3%
    1
    0.8%
    Potassium, serum-high (hyperkalemia)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Potassium, serum-low (hypokalemia)
    0
    0%
    0
    0%
    1
    0.8%
    2
    1.6%
    Prolonged QTc interval
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Proteinuria
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Pruritus/itching
    0
    0%
    1
    1.4%
    0
    0%
    2
    1.6%
    Pulmonary/Upper Respiratory-Other (Specify)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Rash/desquamation
    1
    1.4%
    4
    5.5%
    0
    0%
    2
    1.6%
    Rash: acne/acneiform
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Restrictive cardiomyopathy
    0
    0%
    1
    1.4%
    0
    0%
    0
    0%
    Retinal detachment
    0
    0%
    0
    0%
    0
    0%
    1
    0.8%
    Sodium, serum-high (hypernatremia)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Syncope (fainting)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Vaginal mucositis
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Vision-blurred vision
    1
    1.4%
    1
    1.4%
    1
    0.8%
    0
    0%
    Vomiting
    1
    1.4%
    0
    0%
    1
    0.8%
    0
    0%
    Watery eye (epiphora, tearing)
    0
    0%
    0
    0%
    1
    0.8%
    0
    0%
    Weight gain
    0
    0%
    1
    1.4%
    3
    2.4%
    0
    0%

    Adverse Events

    Time Frame While the patient is on treatment until resolution of acute toxicities with maximum grade reported
    Adverse Event Reporting Description Regular investigator assessments are reported after each cycle of protocol treatment
    Arm/Group Title Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Arm/Group Description Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily Patients received 800 mg imatinib daily Patients received 100 mg dasatinib daily Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
    All Cause Mortality
    Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/72 (5.6%) 0/72 (0%) 20/122 (16.4%) 0/123 (0%)
    Blood and lymphatic system disorders
    Hemoglobin 2/72 (2.8%) 2 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Cardiac disorders
    Left ventricular diastolic dysfunction 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Pericardial effusion (non-malignant) 0/72 (0%) 0 0/72 (0%) 0 2/122 (1.6%) 2 0/123 (0%) 0
    Gastrointestinal disorders
    Colitis 0/72 (0%) 0 0/72 (0%) 0 2/122 (1.6%) 2 0/123 (0%) 0
    Diarrhea 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Nausea 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Ulcer, GI - Duodenum 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Vomiting 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    General disorders
    Edema: limb 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Pain - Chest/thorax NOS 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Infections and infestations
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Infection with normal ANC or Grade 1 or 2 neutrophils - Scrotum 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Investigations
    AST, SGOT (serum glutamic oxaloacetic transaminase) 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    CPK (creatine phosphokinase) 1/72 (1.4%) 1 0/72 (0%) 0 0/122 (0%) 0 0/123 (0%) 0
    Neutrophils/granulocytes (ANC/AGC) 1/72 (1.4%) 1 0/72 (0%) 0 0/122 (0%) 0 0/123 (0%) 0
    Platelets 1/72 (1.4%) 1 0/72 (0%) 0 0/122 (0%) 0 0/123 (0%) 0
    Prolonged QTc interval 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Weight gain 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Metabolism and nutrition disorders
    Dehydration 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Potassium, serum-high (hyperkalemia) 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain - Extremity-limb 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Nervous system disorders
    Pain - Head/headache 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Psychiatric disorders
    Mood alteration - depression 1/72 (1.4%) 1 0/72 (0%) 0 0/122 (0%) 0 0/123 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis 0/72 (0%) 0 0/72 (0%) 0 2/122 (1.6%) 2 0/123 (0%) 0
    Cough 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Dyspnea (shortness of breath) 0/72 (0%) 0 0/72 (0%) 0 3/122 (2.5%) 3 0/123 (0%) 0
    Hypoxia 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Pleural effusion (non-malignant) 0/72 (0%) 0 0/72 (0%) 0 5/122 (4.1%) 5 0/123 (0%) 0
    Pulmonary/Upper Respiratory-Other (Specify) 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash/desquamation 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Vascular disorders
    Hematoma 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Hypertension 0/72 (0%) 0 0/72 (0%) 0 1/122 (0.8%) 1 0/123 (0%) 0
    Other (Not Including Serious) Adverse Events
    Standard Dose Imatinib A High Dose Imatinib Dasatinib Standard Dose Imatinib B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 71/72 (98.6%) 72/72 (100%) 115/122 (94.3%) 120/123 (97.6%)
    Blood and lymphatic system disorders
    Hemoglobin 47/72 (65.3%) 47 59/72 (81.9%) 59 86/122 (70.5%) 86 87/123 (70.7%) 87
    Eye disorders
    Vision-blurred vision 5/72 (6.9%) 5 4/72 (5.6%) 4 0/122 (0%) 0 7/123 (5.7%) 7
    Watery eye (epiphora, tearing) 0/72 (0%) 0 10/72 (13.9%) 10 0/122 (0%) 0 13/123 (10.6%) 13
    Gastrointestinal disorders
    Ascites (non-malignant) 0/72 (0%) 0 6/72 (8.3%) 6 0/122 (0%) 0 0/123 (0%) 0
    Constipation 4/72 (5.6%) 4 6/72 (8.3%) 6 9/122 (7.4%) 9 9/123 (7.3%) 9
    Diarrhea 26/72 (36.1%) 26 40/72 (55.6%) 40 41/122 (33.6%) 41 51/123 (41.5%) 51
    Distention/bloating, abdominal 0/72 (0%) 0 0/72 (0%) 0 0/122 (0%) 0 7/123 (5.7%) 7
    Flatulence 0/72 (0%) 0 9/72 (12.5%) 9 11/122 (9%) 11 9/123 (7.3%) 9
    Heartburn/dyspepsia 7/72 (9.7%) 7 19/72 (26.4%) 19 12/122 (9.8%) 12 22/123 (17.9%) 22
    Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) 0/72 (0%) 0 5/72 (6.9%) 5 0/122 (0%) 0 0/123 (0%) 0
    Nausea 36/72 (50%) 36 42/72 (58.3%) 42 33/122 (27%) 33 63/123 (51.2%) 63
    Pain - Abdomen NOS 7/72 (9.7%) 7 19/72 (26.4%) 19 16/122 (13.1%) 16 16/123 (13%) 16
    Vomiting 11/72 (15.3%) 11 19/72 (26.4%) 19 19/122 (15.6%) 19 25/123 (20.3%) 25
    General disorders
    Edema: head and neck 28/72 (38.9%) 28 43/72 (59.7%) 43 14/122 (11.5%) 14 45/123 (36.6%) 45
    Edema: limb 26/72 (36.1%) 26 29/72 (40.3%) 29 21/122 (17.2%) 21 36/123 (29.3%) 36
    Edema: trunk/genital 0/72 (0%) 0 4/72 (5.6%) 4 0/122 (0%) 0 0/123 (0%) 0
    Fatigue (asthenia, lethargy, malaise) 47/72 (65.3%) 47 57/72 (79.2%) 57 66/122 (54.1%) 66 67/123 (54.5%) 67
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L) 4/72 (5.6%) 4 9/72 (12.5%) 9 15/122 (12.3%) 15 7/123 (5.7%) 7
    Pain - Chest/thorax NOS 0/72 (0%) 0 7/72 (9.7%) 7 11/122 (9%) 11 0/123 (0%) 0
    Rigors/chills 4/72 (5.6%) 4 5/72 (6.9%) 5 0/122 (0%) 0 0/123 (0%) 0
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 6/72 (8.3%) 6 12/72 (16.7%) 12 20/122 (16.4%) 20 15/123 (12.2%) 15
    AST, SGOT (serum glutamic oxaloacetic transaminase) 9/72 (12.5%) 9 18/72 (25%) 18 23/122 (18.9%) 23 18/123 (14.6%) 18
    Alkaline phosphatase 14/72 (19.4%) 14 23/72 (31.9%) 23 20/122 (16.4%) 20 26/123 (21.1%) 26
    Bilirubin (hyperbilirubinemia) 5/72 (6.9%) 5 11/72 (15.3%) 11 7/122 (5.7%) 7 0/123 (0%) 0
    Creatinine 10/72 (13.9%) 10 12/72 (16.7%) 12 13/122 (10.7%) 13 18/123 (14.6%) 18
    Leukocytes (total WBC) 14/72 (19.4%) 14 28/72 (38.9%) 28 34/122 (27.9%) 34 35/123 (28.5%) 35
    Lymphopenia 8/72 (11.1%) 8 8/72 (11.1%) 8 10/122 (8.2%) 10 8/123 (6.5%) 8
    Metabolic/Laboratory-Other (Specify) 5/72 (6.9%) 5 0/72 (0%) 0 0/122 (0%) 0 0/123 (0%) 0
    Neutrophils/granulocytes (ANC/AGC) 22/72 (30.6%) 22 33/72 (45.8%) 33 46/122 (37.7%) 46 45/123 (36.6%) 45
    Platelets 23/72 (31.9%) 23 46/72 (63.9%) 46 71/122 (58.2%) 71 42/123 (34.1%) 42
    Prolonged QTc interval 0/72 (0%) 0 7/72 (9.7%) 7 0/122 (0%) 0 0/123 (0%) 0
    Weight gain 6/72 (8.3%) 6 17/72 (23.6%) 17 18/122 (14.8%) 18 17/123 (13.8%) 17
    Metabolism and nutrition disorders
    Albumin, serum-low (hypoalbuminemia) 5/72 (6.9%) 5 12/72 (16.7%) 12 9/122 (7.4%) 9 0/123 (0%) 0
    Anorexia 11/72 (15.3%) 11 16/72 (22.2%) 16 22/122 (18%) 22 12/123 (9.8%) 12
    Calcium, serum-low (hypocalcemia) 4/72 (5.6%) 4 10/72 (13.9%) 10 12/122 (9.8%) 12 10/123 (8.1%) 10
    Glucose, serum-high (hyperglycemia) 10/72 (13.9%) 10 11/72 (15.3%) 11 15/122 (12.3%) 15 0/123 (0%) 0
    Potassium, serum-low (hypokalemia) 5/72 (6.9%) 5 4/72 (5.6%) 4 9/122 (7.4%) 9 9/123 (7.3%) 9
    Sodium, serum-low (hyponatremia) 0/72 (0%) 0 5/72 (6.9%) 5 0/122 (0%) 0 0/123 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain - Back 0/72 (0%) 0 6/72 (8.3%) 6 0/122 (0%) 0 7/123 (5.7%) 7
    Pain - Bone 9/72 (12.5%) 9 11/72 (15.3%) 11 9/122 (7.4%) 9 8/123 (6.5%) 8
    Pain - Extremity-limb 5/72 (6.9%) 5 5/72 (6.9%) 5 0/122 (0%) 0 0/123 (0%) 0
    Pain - Joint 11/72 (15.3%) 11 15/72 (20.8%) 15 26/122 (21.3%) 26 21/123 (17.1%) 21
    Pain - Muscle 22/72 (30.6%) 22 29/72 (40.3%) 29 15/122 (12.3%) 15 47/123 (38.2%) 47
    Nervous system disorders
    Dizziness 4/72 (5.6%) 4 9/72 (12.5%) 9 13/122 (10.7%) 13 10/123 (8.1%) 10
    Neuropathy: motor 0/72 (0%) 0 4/72 (5.6%) 4 0/122 (0%) 0 0/123 (0%) 0
    Neuropathy: sensory 0/72 (0%) 0 0/72 (0%) 0 15/122 (12.3%) 15 0/123 (0%) 0
    Pain - Head/headache 9/72 (12.5%) 9 9/72 (12.5%) 9 33/122 (27%) 33 23/123 (18.7%) 23
    Taste alteration (dysgeusia) 0/72 (0%) 0 9/72 (12.5%) 9 0/122 (0%) 0 8/123 (6.5%) 8
    Psychiatric disorders
    Insomnia 8/72 (11.1%) 8 10/72 (13.9%) 10 0/122 (0%) 0 11/123 (8.9%) 11
    Mood alteration - depression 5/72 (6.9%) 5 6/72 (8.3%) 6 8/122 (6.6%) 8 0/123 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/72 (0%) 0 7/72 (9.7%) 7 9/122 (7.4%) 9 7/123 (5.7%) 7
    Dyspnea (shortness of breath) 0/72 (0%) 0 6/72 (8.3%) 6 22/122 (18%) 22 12/123 (9.8%) 12
    Hemorrhage, pulmonary/upper respiratory - Nose 0/72 (0%) 0 0/72 (0%) 0 7/122 (5.7%) 7 0/123 (0%) 0
    Pleural effusion (non-malignant) 0/72 (0%) 0 0/72 (0%) 0 16/122 (13.1%) 16 0/123 (0%) 0
    Skin and subcutaneous tissue disorders
    Dry skin 0/72 (0%) 0 5/72 (6.9%) 5 0/122 (0%) 0 0/123 (0%) 0
    Hair loss/Alopecia (scalp or body) 4/72 (5.6%) 4 6/72 (8.3%) 6 11/122 (9%) 11 10/123 (8.1%) 10
    Pruritus/itching 6/72 (8.3%) 6 20/72 (27.8%) 20 11/122 (9%) 11 18/123 (14.6%) 18
    Rash/desquamation 19/72 (26.4%) 19 36/72 (50%) 36 41/122 (33.6%) 41 35/123 (28.5%) 35
    Rash: acne/acneiform 0/72 (0%) 0 0/72 (0%) 0 12/122 (9.8%) 12 0/123 (0%) 0
    Sweating (diaphoresis) 5/72 (6.9%) 5 10/72 (13.9%) 10 8/122 (6.6%) 8 14/123 (11.4%) 14

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title SWOG Leukemia Statistician
    Organization SWOG Statistical Office
    Phone 206-667-4408
    Email
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00070499
    Other Study ID Numbers:
    • NCI-2009-00764
    • NCI-2009-00764
    • S0325
    • S0325
    • S0325
    • U10CA180888
    • U10CA032102
    First Posted:
    Oct 7, 2003
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022