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S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00085709
Collaborator
National Cancer Institute (NCI) (NIH)
637
Enrollment
279
Locations
4
Arms
121
Duration (Months)
2.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.

PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemtuzumab ozogamicin
  • Other: observation
  • Drug: Cytosine arabinoside
  • Drug: Daunomycin
 Phase 3

Detailed Description

OBJECTIVES:

  • Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy.

  • Compare the complete remission rate in patients treated with these regimens.

  • Compare the frequency and severity of the toxic effects of these regimens in these patients.

Other objectives (if funding allows):

  • Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin.

  • Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens.

  • Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens.

  • Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group.

  • Induction therapy: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover.

  • Arm II: Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I.

Patients in both arms undergo bone marrow aspiration and biopsy on day 14 (and on day 19, if applicable) and then proceed to reinduction therapy.

  • Reinduction therapy: Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive G-CSF or GM-CSF as in induction therapy.

Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy.

  • Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who maintain A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy.

  • Post-consolidation therapy: Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

  • Arm II: Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 684 patients (342 per treatment arm) will be accrued for this study within 4.5-5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
637 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post-consolidation GO

Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Drug: gemtuzumab ozogamicin
Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses >/= 28 days apart
Other Names:
  • mylotarg

    		•
    Other: Post-consolidation observation

    Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.

    Other: observation
    No treatment given
    Active Comparator: Induction 7+3

    Standard induction regimen of 7 days of Ara-C (cytosine arabinoside) and 3 days of daunomycin

    Drug: Cytosine arabinoside
    IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
    Other Names:
  • Ara-C

    • Drug: Daunomycin
    IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
    Other Names:
  • daunorubicin

    		•
    Active Comparator: Induction 7+3+GO

    Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin

    Drug: Cytosine arabinoside
    IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
    Other Names:
  • Ara-C

    • Drug: Daunomycin
    IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
    Other Names:
  • daunorubicin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 2-year Disease-free Survival (DFS) [After completing any treatment, every 6 months for 2 years, than annually for years 3-5]

      Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.

    2. Complete Remission [After induction therapy was completed (1 or 2 months)]

    Secondary Outcome Measures

    1. Toxicity [For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.]

      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 to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy* within the past 14 days

    • No M3 disease NOTE: *Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL

    • No blastic transformation of chronic myelogenous leukemia

    • No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)

    PATIENT CHARACTERISTICS:

    Age

    • 18 to 60

    Performance status

    • Zubrod 0-3

    Life expectancy

    • Not specified

    Hematopoietic

    • See Disease Characteristics

    Hepatic

    • Bilirubin ≤ 2 times upper limit of normal (ULN)

    • AST and ALT ≤ 3 times ULN

    • No known hepatitis B or C infection

    • No known liver disease

    Renal

    • Not specified

    Cardiovascular

    • LVEF ≥ 50% by MUGA or echocardiogram

    • No unstable cardiac arrhythmias

    • No unstable angina

    Other

    • 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

    • Not pregnant or nursing

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • No prior systemic chemotherapy

    • Prior hydroxyurea to control high cell counts allowed

    • No more than 1 prior dose of intrathecal chemotherapy for acute leukemia

    • Concurrent intrathecal chemotherapy allowed during induction therapy

    Endocrine therapy

    • Not specified

    Radiotherapy

    • Not specified

    Surgery

    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Cancer Center Anchorage Alaska United States 99508
    2 Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Ft. Smith Arkansas United States 72903
    3 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 Alta Bates Summit Comprehensive Cancer Center Berkeley California United States 94704
    5 Peninsula Medical Center Burlingame California United States 94010
    6 Marin Cancer Institute at Marin General Hospital Greenbrae California United States 94904
    7 Sutter Health - Western Division Cancer Research Group Greenbrae California United States 94904
    8 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90089-9181
    9 California Pacific Medical Center - California Campus San Francisco California United States 94118
    10 Sutter Solano Medical Center Vallejo California United States 94589
    11 Center for Cancer Care and Research at Watson Clinic, LLP Lakeland Florida United States 33805
    12 Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia United States 31701
    13 Medical Center of Central Georgia Macon Georgia United States 31208
    14 Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois United States 62002
    15 St. Joseph Medical Center Bloomington Illinois United States 61701
    16 Graham Hospital Canton Illinois United States 61520
    17 Memorial Hospital Carthage Illinois United States 62321
    18 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
    19 Eureka Community Hospital Eureka Illinois United States 61530
    20 Galesburg Clinic, PC Galesburg Illinois United States 61401
    21 Galesburg Cottage Hospital Galesburg Illinois United States 61401
    22 Mason District Hospital Havana Illinois United States 62644
    23 Hopedale Medical Complex Hopedale Illinois United States 61747
    24 McDonough District Hospital Macomb Illinois United States 61455
    25 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
    26 Good Samaritan Regional Health Center Mt. Vernon Illinois United States 62864
    27 BroMenn Regional Medical Center Normal Illinois United States 61761
    28 Community Cancer Center Normal Illinois United States 61761
    29 Community Hospital of Ottawa Ottawa Illinois United States 61350
    30 Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois United States 61350
    31 Cancer Treatment Center at Pekin Hospital Pekin Illinois United States 61554
    32 Proctor Hospital Peoria Illinois United States 61614
    33 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61615
    34 Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois United States 61615
    35 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    36 OSF St. Francis Medical Center Peoria Illinois United States 61637
    37 Illinois Valley Community Hospital Peru Illinois United States 61354
    38 Perry Memorial Hospital Princeton Illinois United States 61356
    39 St. Margaret's Hospital Spring Valley Illinois United States 61362
    40 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
    41 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
    42 Reid Hospital & Health Care Services Richmond Indiana United States 47374
    43 McFarland Clinic, PC Ames Iowa United States 50010
    44 Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa United States 52803
    45 Genesis Medical Center - West Campus Davenport Iowa United States 52804
    46 Mercy Capitol Hospital Des Moines Iowa United States 50307
    47 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
    48 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
    49 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
    50 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
    51 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    52 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316
    53 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
    54 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
    55 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
    56 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
    57 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
    58 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
    59 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    60 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
    61 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    62 Southwest Medical Center Liberal Kansas United States 67901
    63 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
    64 Menorah Medical Center Overland Park Kansas United States 66209
    65 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
    66 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
    67 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
    68 Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    69 Cotton-O'Neil Cancer Center Topeka Kansas United States 66606
    70 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
    71 Associates in Womens Health, PA - North Review Wichita Kansas United States 67208
    72 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
    73 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
    74 CCOP - Wichita Wichita Kansas United States 67214
    75 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
    76 Wesley Medical Center Wichita Kansas United States 67214
    77 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
    78 Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky United States 40536-0093
    79 Tulane Cancer Center Office of Clinical Research Alexandria Louisiana United States 71315-3198
    80 Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana United States 70806
    81 Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana United States 70809
    82 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    83 Medical Center of Louisiana - New Orleans New Orleans Louisiana United States 70112
    84 Massachusetts General Hospital Boston Massachusetts United States 02114
    85 Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts United States 02115
    86 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
    87 Caritas St. Elizabeth's Medical Center Brighton Massachusetts United States 02135-2997
    88 Saint Joseph Mercy Cancer Center Ann Arbor Michigan United States 48106-0995
    89 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    90 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0942
    91 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
    92 Mecosta County Medical Center Big Rapids Michigan United States 49307
    93 Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan United States 48123-2500
    94 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    95 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
    96 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    97 Hurley Medical Center Flint Michigan United States 48503
    98 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    99 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    100 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
    101 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
    102 Foote Memorial Hospital Jackson Michigan United States 49201
    103 Borgess Medical Center Kalamazoo Michigan United States 49001
    104 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
    105 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    106 Sparrow Regional Cancer Center Lansing Michigan United States 48912-1811
    107 St. Mary Mercy Hospital Livonia Michigan United States 48154
    108 Mercy General Health Partners Muskegon Michigan United States 49443
    109 St. Joseph Mercy Oakland Pontiac Michigan United States 48341-2985
    110 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
    111 Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan United States 48601
    112 Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan United States 48075
    113 Munson Medical Center Traverse City Michigan United States 49684
    114 St. John Macomb Hospital Warren Michigan United States 48093
    115 Metro Health Hospital Wyoming Michigan United States 49519
    116 Duluth Clinic Cancer Center - Duluth Duluth Minnesota United States 55805-1983
    117 CCOP - Duluth Duluth Minnesota United States 55805
    118 Miller - Dwan Medical Center Duluth Minnesota United States 55805
    119 University of Mississippi Cancer Clinic Jackson Mississippi United States 39216
    120 Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Cape Girardeau Missouri United States 63701
    121 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    122 Independence Regional Health Center Independence Missouri United States 64050
    123 Truman Medical Center - Hospital Hill Kansas City Missouri United States 64108
    124 Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri United States 64111
    125 St. Joseph Medical Center Kansas City Missouri United States 64114
    126 North Kansas City Hospital Kansas City Missouri United States 64116
    127 Parvin Radiation Oncology Kansas City Missouri United States 64116
    128 CCOP - Kansas City Kansas City Missouri United States 64131
    129 Research Medical Center Kansas City Missouri United States 64132
    130 Liberty Hospital Liberty Missouri United States 64068
    131 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    132 Midwest Hematology Oncology Group, Incorporated Saint Louis Missouri United States 63109
    133 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    134 David C. Pratt Cancer Center at St. John's Mercy Saint Louis Missouri United States 63141
    135 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    136 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
    137 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
    138 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
    139 Billings Clinic - Downtown Billings Montana United States 59107-7000
    140 St. James Healthcare Cancer Care Butte Montana United States 59701
    141 Big Sky Oncology Great Falls Montana United States 59405-5309
    142 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
    143 Sletten Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
    144 Great Falls Montana United States 59405
    145 Northern Montana Hospital Havre Montana United States 59501
    146 St. Peter's Hospital Helena Montana United States 59601
    147 Glacier Oncology, PLLC Kalispell Montana United States 59901
    148 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
    149 Kalispell Regional Medical Center Kalispell Montana United States 59901
    150 Community Medical Center Missoula Montana United States 59801
    151 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
    152 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
    153 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
    154 Methodist Estabrook Cancer Center Omaha Nebraska United States 68114
    155 UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska United States 68198-6805
    156 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    157 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    158 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    159 University of New Mexico Cancer Center Albuquerque New Mexico United States 87131-5636
    160 New Mexico Cancer Care Associates Santa Fe New Mexico United States 87505
    161 Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina United States 28233-3549
    162 Kinston Medical Specialists Kinston North Carolina United States 28501
    163 Rutherford Hospital Rutherfordton North Carolina United States 28139
    164 McDowell Cancer Center at Akron General Medical Center Akron Ohio United States 44307
    165 Mary Rutan Hospital Bellefontaine Ohio United States 43311
    166 Mercy Cancer Center at Mercy Medical Center Canton Ohio United States 44708
    167 Aultman Cancer Center at Aultman Hospital Canton Ohio United States 44710-1799
    168 Adena Regional Medical Center Chillicothe Ohio United States 45601
    169 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
    170 CCOP - Columbus Columbus Ohio United States 43215
    171 Grant Medical Center Cancer Care Columbus Ohio United States 43215
    172 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
    173 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
    174 Grandview Hospital Dayton Ohio United States 45405
    175 Good Samaritan Hospital Dayton Ohio United States 45406
    176 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
    177 CCOP - Dayton Dayton Ohio United States 45429
    178 Grady Memorial Hospital Delaware Ohio United States 43015
    179 Blanchard Valley Medical Associates Findlay Ohio United States 45840
    180 Middletown Regional Hospital Franklin Ohio United States 45005-1066
    181 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
    182 Fairfield Medical Center Lancaster Ohio United States 43130
    183 St. Rita's Medical Center Lima Ohio United States 45801
    184 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
    185 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
    186 Mercy Medical Center Springfield Ohio United States 45504
    187 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
    188 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
    189 Mount Carmel St. Ann's Cancer Center Westerville Ohio United States 43081
    190 Clinton Memorial Hospital Wilmington Ohio United States 45177
    191 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
    192 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
    193 Lancaster General Hospital Lancaster Pennsylvania United States 17604
    194 Guthrie Cancer Center at Guthrie Clinic Sayre Sayre Pennsylvania United States 18840
    195 Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania United States 18501
    196 Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania United States 18510
    197 AnMed Cancer Center Anderson South Carolina United States 29621
    198 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    199 McLeod Regional Medical Center Florence South Carolina United States 29501
    200 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    201 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    202 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    203 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
    204 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
    205 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229-3900
    206 Cancer Therapy and Research Center San Antonio Texas United States 78229
    207 University Hospital - San Antonio San Antonio Texas United States 78229
    208 American Fork Hospital American Fork Utah United States 84003
    209 Sandra L. Maxwell Cancer Center Cedar City Utah United States 84720
    210 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah United States 84157
    211 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah United States 84403
    212 Utah Valley Regional Medical Center - Provo Provo Utah United States 84604
    213 Dixie Regional Medical Center - East Campus Saint George Utah United States 84770
    214 LDS Hospital Salt Lake City Utah United States 84103
    215 Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah United States 84106
    216 Huntsman Cancer Institute at University of Utah Salt Lake City Utah United States 84112
    217 Auburn Regional Center for Cancer Care Auburn Washington United States 98002
    218 St. Joseph Cancer Center Bellingham Washington United States 98225
    219 Olympic Hematology and Oncology Bremerton Washington United States 98310
    220 Providence Centralia Hospital Centralia Washington United States 98531-9027
    221 St. Francis Hospital Federal Way Washington United States 98003
    222 Columbia Basin Hematology Kennewick Washington United States 99336
    223 Providence St. Peter Hospital Regional Cancer Center Olympia Washington United States 98506-5166
    224 Good Samaritan Cancer Center Puyallup Washington United States 98372
    225 Fred Hutchinson Cancer Research Center Seattle Washington United States 98104
    226 Harborview Medical Center Seattle Washington United States 98104
    227 Group Health Central Hospital Seattle Washington United States 98112
    228 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington United States 98122-4307
    229 Polyclinic First Hill Seattle Washington United States 98122
    230 University Cancer Center at University of Washington Medical Center Seattle Washington United States 98195-6043
    231 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
    232 Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington United States 98405-3004
    233 Allenmore Hospital Tacoma Washington United States 98405
    234 CCOP - Northwest Tacoma Washington United States 98405
    235 MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington United States 98405
    236 Madigan Army Medical Center - Tacoma Tacoma Washington United States 98431
    237 St. Clare Hospital Tacoma Washington United States 98499
    238 West Virginia University Health Sciences Center - Charleston Charleston West Virginia United States 25304
    239 Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg West Virginia United States 26102
    240 Marshfield Clinic - Chippewa Center Chippewa Falls Wisconsin United States 54729
    241 Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin United States 54701
    242 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54301-3526
    243 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
    244 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
    245 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
    246 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
    247 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
    248 Froedtert Hospital and Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    249 Medical College of Wisconsin Cancer Center Milwaukee Wisconsin United States 53226
    250 Marshfield Clinic - Lakeland Center Minocqua Wisconsin United States 54548
    251 Marshfield Clinic - Indianhead Center Rice Lake Wisconsin United States 54868
    252 Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin United States 53188
    253 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    254 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    255 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801
    256 Cross Cancer Institute at University of Alberta Edmonton Alberta Canada T6G 1Z2
    257 University of British Columbia Vancouver British Columbia Canada V6T 1Z4
    258 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    259 Moncton Hospital Moncton New Brunswick Canada E1C 6Z8
    260 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V8
    261 Margaret and Charles Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
    262 Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario Canada K7L 5P9
    263 London Regional Cancer Program at London Health Sciences Centre London Ontario Canada N6A 4L6
    264 Cancer Care Program at Thunder Bay Regional Health Sciences Thunder Bay Ontario Canada P7B 6V4
    265 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    266 Hopital Charles Lemoyne Greenfield Park Quebec Canada J4V 2H1
    267 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4
    268 McGill Cancer Centre at McGill University Montreal Quebec Canada H2W 1S6
    269 Hopital du Saint-Sacrement - Quebec Quebec City Quebec Canada G1S 4L8
    270 Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan Canada S4T 7T1
    271 Saskatoon Cancer Centre at the University of Saskatchewan Saskatoon Saskatchewan Canada S7N 4H4
    272 Sahlgrenska University Hospital Goteborg Sweden 413 45
    273 Karolinska University Hospital - Huddinge Huddinge Sweden SE-141 86
    274 University Hospital of Linkoping Linkoping Sweden 85
    275 Lund University Hospital Lund Sweden S-221 00
    276 Orebro University Hospital Orebro Sweden SE-700
    277 Karolinska University Hospital - Solna Stockholm Sweden 171 76
    278 Sundsvall Hospital Sundsvalls Sweden SE-85186
    279 Uppsala University Hospital Uppsala Sweden

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Stephen H. Petersdorf, MD, Seattle Cancer Care Alliance

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00085709
    Other Study ID Numbers:
    • S0106
    • U10CA032102
    • S0106
    First Posted:
    Jun 16, 2004
    Last Update Posted:
    Sep 30, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by Southwest Oncology Group
    untreated adult acute myeloid leukemia
    adult acute eosinophilic leukemia
    adult acute basophilic leukemia
    adult acute monocytic leukemia (M5b)
    adult acute erythroid leukemia (M6)
    adult acute megakaryoblastic leukemia (M7)
    adult acute minimally differentiated myeloid leukemia (M0)
    adult acute myeloblastic leukemia with maturation (M2)
    adult acute myeloblastic leukemia without maturation (M1)
    adult acute myelomonocytic leukemia (M4)
    adult acute monoblastic leukemia (M5a)
    adult acute myeloid leukemia with 11q23 (MLL) abnormalities
    adult acute myeloid leukemia with inv(16)(p13;q22)
    adult acute myeloid leukemia with t(16;16)(p13;q22)
    adult acute myeloid leukemia with t(8;21)(q22;q22)
    Additional relevant MeSH terms:
    Leukemia
    Cytarabine
    Daunorubicin
    Gemtuzumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin
    Arm/Group Description Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
    Period Title: Overall Study
    STARTED 317 320
    Eligible 298 301
    Eligible and Did Not Withdraw Consent 296 300
    COMPLETED 264 270
    NOT COMPLETED 53 50

    Baseline Characteristics

    Arm/Group Title Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin Total
    Arm/Group Description Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin Total of all reporting groups
    Overall Participants 296 300 596
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    47
    48
    47
    Sex: Female, Male (Count of Participants)
    Female
    135
    45.6%
    148
    49.3%
    283
    47.5%
    Male
    161
    54.4%
    152
    50.7%
    313
    52.5%

    Outcome Measures

    1. Primary Outcome
    Title 2-year Disease-free Survival (DFS)
    Description Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
    Time Frame After completing any treatment, every 6 months for 2 years, than annually for years 3-5

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who completed induction and consolidation therapy
    Arm/Group Title Post-consolidation GO Post-consolidation Observation
    Arm/Group Description For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart. Patients did not receive any post-consolidation therapy
    Measure Participants 84 84
    Number (95% Confidence Interval) [Percentage of population]
    39
    50
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Post-consolidation GO, Post-consolidation Observation
    Comments Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Cox
    Comments The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.
    2. Primary Outcome
    Title Complete Remission
    Description
    Time Frame After induction therapy was completed (1 or 2 months)

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who did not withdraw consent
    Arm/Group Title Ara-C+Daunomycin Ara-C+Daunomycin+Mylotarg
    Arm/Group Description A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
    Measure Participants 296 300
    Number [participants]
    203
    68.6%
    207
    69%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Post-consolidation GO, Post-consolidation Observation
    Comments Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0025
    Comments
    Method Test of difference of proportions
    Comments
    3. 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 For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.

    Outcome Measure Data

    Analysis Population Description
    Eligible patients who started therapy
    Arm/Group Title Ara-C+Daunomycin+Mylotarg Ara-C+Daunomycin Ara-C Consolidation Post-consolidation G.O.
    Arm/Group Description A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment. For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
    Measure Participants 293 294 377 79
    ALT, SGPT (serum glutamic pyruvic transaminase)
    29
    9.8%
    11
    3.7%
    22
    3.7%
    2
    NaN
    AST, SGOT (serum glut. oxaloacetic transaminase)
    32
    10.8%
    11
    3.7%
    17
    2.9%
    2
    NaN
    Acidosis (metabolic or respiratory)
    2
    0.7%
    0
    0%
    2
    0.3%
    0
    NaN
    Adult respiratory distress syndrome (ARDS)
    7
    2.4%
    0
    0%
    2
    0.3%
    0
    NaN
    Albumin, serum-low (hypoalbuminemia)
    15
    5.1%
    10
    3.3%
    3
    0.5%
    0
    NaN
    Alkaline phosphatase
    3
    1%
    2
    0.7%
    2
    0.3%
    0
    NaN
    Alkalosis (metabolic or respiratory)
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Allergic reaction/hypersens. (inc drug fever)
    6
    2%
    0
    0%
    0
    0%
    0
    NaN
    Amylase
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Anorexia
    14
    4.7%
    13
    4.3%
    2
    0.3%
    0
    NaN
    Apnea
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Ataxia (incoordination)
    0
    0%
    0
    0%
    2
    0.3%
    0
    NaN
    Bicarbonate, serum-low
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Bilirubin (hyperbilirubinemia)
    14
    4.7%
    11
    3.7%
    4
    0.7%
    0
    NaN
    Blood/Bone Marrow-Other (Specify)
    0
    0%
    1
    0.3%
    2
    0.3%
    0
    NaN
    Bronchospasm, wheezing
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Calcium, serum-low (hypocalcemia)
    13
    4.4%
    7
    2.3%
    3
    0.5%
    0
    NaN
    Cardiac Arrhythmia-Other (Specify)
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Cardiac General-Other (Specify)
    0
    0%
    2
    0.7%
    0
    0%
    0
    NaN
    Cardiac troponin I (cTnI)
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Cardiac troponin T (cTnT)
    0
    0%
    0
    0%
    3
    0.5%
    0
    NaN
    Cardiac-ischemia/infarction
    2
    0.7%
    1
    0.3%
    4
    0.7%
    0
    NaN
    Colitis
    2
    0.7%
    6
    2%
    1
    0.2%
    0
    NaN
    Colitis, infectious (e.g., Clostridium difficile)
    8
    2.7%
    10
    3.3%
    4
    0.7%
    0
    NaN
    Confusion
    3
    1%
    1
    0.3%
    0
    0%
    0
    NaN
    Constipation
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Cough
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Creatinine
    3
    1%
    2
    0.7%
    0
    0%
    0
    NaN
    DIC (disseminated intravascular coagulation)
    2
    0.7%
    0
    0%
    0
    0%
    0
    NaN
    Death not assoc with CTCAE term-Multi-organ failu
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Dehydration
    0
    0%
    0
    0%
    1
    0.2%
    1
    NaN
    Diarrhea
    5
    1.7%
    19
    6.3%
    4
    0.7%
    0
    NaN
    Distention/bloating, abdominal
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Dizziness
    2
    0.7%
    0
    0%
    3
    0.5%
    0
    NaN
    Dysphagia (difficulty swallowing)
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Dyspnea (shortness of breath)
    10
    3.4%
    6
    2%
    10
    1.7%
    0
    NaN
    Edema, larynx
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Edema: limb
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Edema: viscera
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Enteritis (inflammation of the small bowel)
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Esophagitis
    1
    0.3%
    3
    1%
    0
    0%
    0
    NaN
    Fatigue (asthenia, lethargy, malaise)
    24
    8.1%
    25
    8.3%
    22
    3.7%
    4
    NaN
    Febrile neutropenia
    178
    60.1%
    196
    65.3%
    183
    30.7%
    22
    NaN
    Fever (in the absence of neutropenia)
    6
    2%
    8
    2.7%
    16
    2.7%
    1
    NaN
    Fistula, GI - Rectum
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Fistula, GU - Vagina
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Flu-like syndrome
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    GGT (gamma-glutamyl transpeptidase)
    1
    0.3%
    0
    0%
    4
    0.7%
    0
    NaN
    Glucose, serum-high (hyperglycemia)
    22
    7.4%
    12
    4%
    15
    2.5%
    2
    NaN
    Glucose, serum-low (hypoglycemia)
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Hematoma
    1
    0.3%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Hemoglobin
    101
    34.1%
    87
    29%
    144
    24.2%
    2
    NaN
    Hemolysis
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Hemorrhage, CNS
    5
    1.7%
    1
    0.3%
    0
    0%
    0
    NaN
    Hemorrhage, GI - Abdomen NOS
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Hemorrhage, GI - Jejunum
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Hemorrhage, GI - Lower GI NOS
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Hemorrhage, GI - Oral cavity
    1
    0.3%
    0
    0%
    2
    0.3%
    0
    NaN
    Hemorrhage, GI - Rectum
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Hemorrhage, GU - Bladder
    2
    0.7%
    0
    0%
    0
    0%
    0
    NaN
    Hemorrhage, GU - Kidney
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Hemorrhage, GU - Urinary NOS
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Hemorrhage, GU - Uterus
    0
    0%
    2
    0.7%
    0
    0%
    0
    NaN
    Hemorrhage, GU - Vagina
    1
    0.3%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Hemorrhage, pulmonary/upper respiratory - Lung
    5
    1.7%
    0
    0%
    0
    0%
    0
    NaN
    Hemorrhage, pulmonary/upper respiratory - Nose
    3
    1%
    1
    0.3%
    4
    0.7%
    0
    NaN
    Hemorrhage/Bleeding-Other (Specify)
    8
    2.7%
    5
    1.7%
    12
    2%
    0
    NaN
    Hepatobiliary/Pancreas-Other (Specify)
    3
    1%
    0
    0%
    0
    0%
    0
    NaN
    Hiccoughs (hiccups, singultus)
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Hypertension
    2
    0.7%
    3
    1%
    2
    0.3%
    0
    NaN
    Hypotension
    5
    1.7%
    1
    0.3%
    4
    0.7%
    1
    NaN
    Hypoxia
    8
    2.7%
    2
    0.7%
    6
    1%
    0
    NaN
    Infec with Grade 3 or 4 neut - Abdomen NOS
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Anal/perianal
    0
    0%
    2
    0.7%
    4
    0.7%
    0
    NaN
    Infec with Grade 3 or 4 neut - Appendix
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Bladder (urin
    2
    0.7%
    1
    0.3%
    4
    0.7%
    0
    NaN
    Infec with Grade 3 or 4 neut - Blood
    30
    10.1%
    25
    8.3%
    47
    7.9%
    4
    NaN
    Infec with Grade 3 or 4 neut - Bone (osteomy
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Brain + Spina
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Bronchus
    0
    0%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Catheter-rela
    5
    1.7%
    6
    2%
    13
    2.2%
    2
    NaN
    Infec with Grade 3 or 4 neut - Cecum
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Colon
    5
    1.7%
    2
    0.7%
    2
    0.3%
    0
    NaN
    Infec with Grade 3 or 4 neut - Dental-tooth
    1
    0.3%
    2
    0.7%
    3
    0.5%
    0
    NaN
    Infec with Grade 3 or 4 neut - Heart (endoca
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Lip/perioral
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Liver
    0
    0%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Lung (pneumon
    22
    7.4%
    27
    9%
    22
    3.7%
    0
    NaN
    Infec with Grade 3 or 4 neut - Meninges (men
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infect with Grade 3 or 4 neut - Mucosa
    1
    0.3%
    2
    0.7%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Nerve-periphe
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Oral cavity-g
    2
    0.7%
    3
    1%
    2
    0.3%
    0
    NaN
    Infec with Grade 3 or 4 neut - Pelvis NOS
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut- Pharynx
    0
    0%
    1
    0.3%
    1
    0.2%
    1
    NaN
    Infec with Grade 3 or 4 neut - Rectum
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infec with Grade 3 or 4 neut - Sinus
    2
    0.7%
    3
    1%
    2
    0.3%
    0
    NaN
    Infec with Grade 3 or 4 neut - Skin (celluli
    4
    1.4%
    3
    1%
    9
    1.5%
    1
    NaN
    Infec with Grade 3 or 4 neut - Small bowel N
    0
    0%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Upper airway
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infection with Grade 3 or 4 neut - Urinary tract
    6
    2%
    6
    2%
    6
    1%
    0
    NaN
    Infec with Grade 3 or 4 neut - Vulva
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with Grade 3 or 4 neut - Wound
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with normal ANC or Grade 1/2 neut - Blood
    0
    0%
    0
    0%
    6
    1%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut, Catheter-rel
    0
    0%
    1
    0.3%
    4
    0.7%
    0
    NaN
    Infec with norm ANC or Grade 1/2 neut - Colon
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neutr- Dental-tooth
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut - Heart
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neutrophils - Liver
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni)
    6
    2%
    0
    0%
    9
    1.5%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut - Muscle
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut - Scrotum
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut-Skin
    2
    0.7%
    0
    0%
    0
    0%
    0
    NaN
    Infec with norm ANC or Gr 1/2 neut-Urinary tract
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infection with unknown ANC - Blood
    0
    0%
    3
    1%
    7
    1.2%
    0
    NaN
    Infection with unknown ANC - Catheter-related
    3
    1%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Infection with unknown ANC - Dental-tooth
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infection with unknown ANC - Joint
    0
    0%
    0
    0%
    2
    0.3%
    0
    NaN
    Infection with unknown ANC - Liver
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infection with unknown ANC - Lung (pneumonia)
    0
    0%
    2
    0.7%
    2
    0.3%
    0
    NaN
    Infection with unknown ANC - Mucosa
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Infection with unknown ANC - Sinus
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Infection with unknown ANC - Skin (cellulitis)
    4
    1.4%
    3
    1%
    3
    0.5%
    0
    NaN
    Infection with unknown ANC - Urinary tract NOS
    1
    0.3%
    1
    0.3%
    0
    0%
    0
    NaN
    Infection with unknown ANC - Wound
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Infection-Other (Specify)
    4
    1.4%
    4
    1.3%
    4
    0.7%
    0
    NaN
    Left ventricular diastolic dysfunction
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Left ventricular systolic dysfunction
    1
    0.3%
    1
    0.3%
    2
    0.3%
    0
    NaN
    Leukocytes (total WBC)
    106
    35.8%
    96
    32%
    151
    25.3%
    41
    NaN
    Leukoencephalopathy (radiolographic findings)
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Liver dysfunction/failure (clinical)
    4
    1.4%
    1
    0.3%
    0
    0%
    0
    NaN
    Lymphopenia
    21
    7.1%
    23
    7.7%
    50
    8.4%
    4
    NaN
    Magnesium, serum-low (hypomagnesemia)
    1
    0.3%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Metabolic/Laboratory-Other (Specify)
    3
    1%
    5
    1.7%
    4
    0.7%
    0
    NaN
    Mood alteration - anxiety
    1
    0.3%
    0
    0%
    1
    0.2%
    0
    NaN
    Mood alteration - depression
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (clinical exam) - Esophagus
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (clinical exam) - Large bowel
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (clinical exam) - Larynx
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (clinical exam) - Oral cavity
    6
    2%
    11
    3.7%
    2
    0.3%
    0
    NaN
    Mucositis/stomatitis (clinical exam) - Pharynx
    2
    0.7%
    2
    0.7%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (func/sympt) - Esophagus
    0
    0%
    2
    0.7%
    0
    0%
    0
    NaN
    Mucositis/stomatitis (func/sympt)- Oral cavity
    4
    1.4%
    9
    3%
    1
    0.2%
    0
    NaN
    Mucositis/stomatitis (func/sympt) - Pharynx
    1
    0.3%
    2
    0.7%
    1
    0.2%
    0
    NaN
    Muscle weakness (func/sym, Whole body/generalized
    0
    0%
    1
    0.3%
    2
    0.3%
    0
    NaN
    Nasal cavity/paranasal sinus reactions
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Nausea
    7
    2.4%
    13
    4.3%
    7
    1.2%
    1
    NaN
    Necrosis, GI - Rectum
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Neurology-Other (Specify)
    1
    0.3%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Neuropathy: motor
    0
    0%
    0
    0%
    2
    0.3%
    0
    NaN
    Neuropathy: sensory
    1
    0.3%
    0
    0%
    1
    0.2%
    0
    NaN
    Neutrophils/granulocytes (ANC/AGC)
    111
    37.5%
    110
    36.7%
    193
    32.4%
    43
    NaN
    Nystagmus
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Obstruction/stenosis of airway - Trachea
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Ocular/Visual-Other (Specify)
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Opportunistic infec assoc with Gr 2 lymphopenia
    0
    0%
    2
    0.7%
    0
    0%
    1
    NaN
    PTT (Partial thromboplastin time)
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Pain - Abdomen NOS
    8
    2.7%
    5
    1.7%
    3
    0.5%
    0
    NaN
    Pain - Anus
    0
    0%
    0
    0%
    1
    0.2%
    1
    NaN
    Pain - Back
    1
    0.3%
    0
    0%
    1
    0.2%
    1
    NaN
    Pain - Bone
    0
    0%
    0
    0%
    4
    0.7%
    0
    NaN
    Pain - Chest/thorax NOS
    2
    0.7%
    1
    0.3%
    2
    0.3%
    0
    NaN
    Pain - Extremity-limb
    0
    0%
    1
    0.3%
    1
    0.2%
    1
    NaN
    Pain - Eye
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Pain - Head/headache
    8
    2.7%
    1
    0.3%
    8
    1.3%
    1
    NaN
    Pain - Joint
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Pain - Muscle
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Pain - Oral-gums
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Pain - Rectum
    0
    0%
    0
    0%
    0
    0%
    1
    NaN
    Pain - Throat/pharynx/larynx
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Pain-Other (Specify)
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Pancreatic endocrine: glucose intolerance
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Perforation, GI - Colon
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Pericardial effusion (non-malignant)
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Pericarditis
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Petechiae/purpura
    6
    2%
    2
    0.7%
    3
    0.5%
    1
    NaN
    Phosphate, serum-low (hypophosphatemia)
    10
    3.4%
    9
    3%
    6
    1%
    1
    NaN
    Platelets
    145
    49%
    130
    43.3%
    226
    37.9%
    40
    NaN
    Pleural effusion (non-malignant)
    1
    0.3%
    1
    0.3%
    3
    0.5%
    0
    NaN
    Pneumonitis/pulmonary infiltrates
    3
    1%
    1
    0.3%
    5
    0.8%
    0
    NaN
    Portal vein flow
    2
    0.7%
    0
    0%
    0
    0%
    0
    NaN
    Potassium, serum-high (hyperkalemia)
    4
    1.4%
    2
    0.7%
    0
    0%
    0
    NaN
    Potassium, serum-low (hypokalemia)
    21
    7.1%
    15
    5%
    19
    3.2%
    3
    NaN
    Proctitis
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Pulmonary/Upper Respiratory-Other (Specify)
    1
    0.3%
    0
    0%
    1
    0.2%
    0
    NaN
    Rash/desquamation
    6
    2%
    9
    3%
    1
    0.2%
    0
    NaN
    Renal failure
    8
    2.7%
    6
    2%
    0
    0%
    0
    NaN
    Rigors/chills
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Seroma
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Serum sickness
    0
    0%
    0
    0%
    0
    0%
    1
    NaN
    Sodium, serum-high (hypernatremia)
    2
    0.7%
    0
    0%
    0
    0%
    0
    NaN
    Sodium, serum-low (hyponatremia)
    8
    2.7%
    15
    5%
    4
    0.7%
    0
    NaN
    Somnolence/depressed level of consciousness
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Atrial fibrillation
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Sinus tachycardia
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Supraventricular arrhythmia NOS
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Syncope (fainting)
    1
    0.3%
    3
    1%
    4
    0.7%
    0
    NaN
    Syndromes-Other (Specify)
    0
    0%
    0
    0%
    2
    0.3%
    0
    NaN
    Thrombosis/embolism (vascular access-related)
    0
    0%
    1
    0.3%
    1
    0.2%
    0
    NaN
    Thrombosis/thrombus/embolism
    4
    1.4%
    4
    1.3%
    4
    0.7%
    0
    NaN
    Thrombotic microangiopathy
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Tumor lysis syndrome
    2
    0.7%
    2
    0.7%
    0
    0%
    0
    NaN
    Typhlitis (cecal inflammation)
    3
    1%
    4
    1.3%
    1
    0.2%
    0
    NaN
    Uric acid, serum-high (hyperuricemia)
    1
    0.3%
    0
    0%
    1
    0.2%
    0
    NaN
    Vasovagal episode
    0
    0%
    0
    0%
    1
    0.2%
    0
    NaN
    Ventricular arrhythmia - Ventricular fibrillation
    1
    0.3%
    0
    0%
    0
    0%
    0
    NaN
    Vision-blurred vision
    0
    0%
    1
    0.3%
    0
    0%
    0
    NaN
    Vomiting
    2
    0.7%
    5
    1.7%
    5
    0.8%
    1
    NaN

    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 Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
    Arm/Group Description A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment. For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
    All Cause Mortality
    Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 47/293 (16%) 9/293 (3.1%) 13/375 (3.5%) 19/78 (24.4%)
    Blood and lymphatic system disorders
    DIC (disseminated intravascular coagulation) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Febrile neutropenia 7/293 (2.4%) 7 1/293 (0.3%) 1 4/375 (1.1%) 4 9/78 (11.5%) 9
    Hemoglobin 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Cardiac disorders
    Cardiac-ischemia/infarction 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Pericardial effusion (non-malignant) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Pericarditis 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Gastrointestinal disorders
    Colitis 0/293 (0%) 0 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Mucositis/stomatitis (clinical exam) - Oral cavity 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Nausea 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Pain - Rectum 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Perforation, GI - Colon 0/293 (0%) 0 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Typhlitis (cecal inflammation) 1/293 (0.3%) 1 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Vomiting 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    General disorders
    Death not associated with CTCAE term - Multi-organ failure 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Fatigue (asthenia, lethargy, malaise) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Syndromes-Other (Specify) 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Hepatobiliary disorders
    Hepatobiliary/Pancreas-Other (Specify) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Liver dysfunction/failure (clinical) 4/293 (1.4%) 4 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Portal vein flow 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Immune system disorders
    Allergic reaction/hypersensitivity (including drug fever) 2/293 (0.7%) 2 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infections and infestations
    Colitis, infectious (e.g., Clostridium difficile) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood 8/293 (2.7%) 8 2/293 (0.7%) 2 1/375 (0.3%) 1 3/78 (3.8%) 3
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Heart (endoca 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon 3/293 (1%) 3 1/293 (0.3%) 1 1/375 (0.3%) 1 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pelvis NOS 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (celluli 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Infection-Other (Specify) 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 5/293 (1.7%) 5 0/293 (0%) 0 1/375 (0.3%) 1 1/78 (1.3%) 1
    AST, SGOT (serum glutamic oxaloacetic transaminase) 4/293 (1.4%) 4 0/293 (0%) 0 1/375 (0.3%) 1 1/78 (1.3%) 1
    Alkaline phosphatase 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Bilirubin (hyperbilirubinemia) 3/293 (1%) 3 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Creatinine 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Leukocytes (total WBC) 5/293 (1.7%) 5 0/293 (0%) 0 1/375 (0.3%) 1 2/78 (2.6%) 2
    Metabolic/Laboratory-Other (Specify) 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Neutrophils/granulocytes (ANC/AGC) 3/293 (1%) 3 0/293 (0%) 0 1/375 (0.3%) 1 5/78 (6.4%) 5
    Platelets 9/293 (3.1%) 9 1/293 (0.3%) 1 1/375 (0.3%) 1 2/78 (2.6%) 2
    Metabolism and nutrition disorders
    Calcium, serum-low (hypocalcemia) 3/293 (1%) 3 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Dehydration 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Glucose, serum-high (hyperglycemia) 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 1/78 (1.3%) 1
    Glucose, serum-low (hypoglycemia) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Pancreatic endocrine: glucose intolerance 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Potassium, serum-low (hypokalemia) 1/293 (0.3%) 1 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Uric acid, serum-high (hyperuricemia) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain - Joint 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Nervous system disorders
    Hemorrhage, CNS 5/293 (1.7%) 5 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Leukoencephalopathy (radiolographic findings) 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Neurology-Other (Specify) 1/293 (0.3%) 1 1/293 (0.3%) 1 0/375 (0%) 0 0/78 (0%) 0
    Renal and urinary disorders
    Hemorrhage, GU - Bladder 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Hemorrhage, GU - Kidney 2/293 (0.7%) 2 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome (ARDS) 5/293 (1.7%) 5 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Dyspnea (shortness of breath) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Hemorrhage, pulmonary/upper respiratory - Lung 5/293 (1.7%) 5 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Hypoxia 4/293 (1.4%) 4 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Pleural effusion (non-malignant) 2/293 (0.7%) 2 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Pneumonitis/pulmonary infiltrates 2/293 (0.7%) 2 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Pulmonary/Upper Respiratory-Other (Specify) 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Skin and subcutaneous tissue disorders
    Rash/desquamation 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Vascular disorders
    Hemorrhage/Bleeding-Other (Specify) 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Hypotension 1/293 (0.3%) 1 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Phlebitis (including superficial thrombosis) 1/293 (0.3%) 1 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Thrombosis/thrombus/embolism 0/293 (0%) 0 0/293 (0%) 0 1/375 (0.3%) 1 0/78 (0%) 0
    Other (Not Including Serious) Adverse Events
    Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 277/293 (94.5%) 279/293 (95.2%) 356/375 (94.9%) 77/78 (98.7%)
    Blood and lymphatic system disorders
    Febrile neutropenia 172/293 (58.7%) 172 194/293 (66.2%) 194 178/375 (47.5%) 178 14/78 (17.9%) 14
    Hemoglobin 116/293 (39.6%) 116 109/293 (37.2%) 109 201/375 (53.6%) 201 27/78 (34.6%) 27
    Eye disorders
    Vision-blurred vision 0/293 (0%) 0 0/293 (0%) 0 19/375 (5.1%) 19 0/78 (0%) 0
    Gastrointestinal disorders
    Constipation 36/293 (12.3%) 36 32/293 (10.9%) 32 46/375 (12.3%) 46 5/78 (6.4%) 5
    Diarrhea 115/293 (39.2%) 115 130/293 (44.4%) 130 76/375 (20.3%) 76 9/78 (11.5%) 9
    Heartburn/dyspepsia 0/293 (0%) 0 25/293 (8.5%) 25 20/375 (5.3%) 20 0/78 (0%) 0
    Hemorrhage, GI - Oral cavity 0/293 (0%) 0 0/293 (0%) 0 19/375 (5.1%) 19 0/78 (0%) 0
    Mucositis/stomatitis (clinical exam) - Oral cavity 76/293 (25.9%) 76 64/293 (21.8%) 64 63/375 (16.8%) 63 8/78 (10.3%) 8
    Mucositis/stomatitis (functional/symptomatic) - Oral cavity 33/293 (11.3%) 33 37/293 (12.6%) 37 35/375 (9.3%) 35 0/78 (0%) 0
    Nausea 165/293 (56.3%) 165 159/293 (54.3%) 159 182/375 (48.5%) 182 40/78 (51.3%) 40
    Pain - Abdomen NOS 51/293 (17.4%) 51 35/293 (11.9%) 35 31/375 (8.3%) 31 8/78 (10.3%) 8
    Vomiting 93/293 (31.7%) 93 75/293 (25.6%) 75 97/375 (25.9%) 97 22/78 (28.2%) 22
    General disorders
    Edema: limb 38/293 (13%) 38 24/293 (8.2%) 24 27/375 (7.2%) 27 0/78 (0%) 0
    Fatigue (asthenia, lethargy, malaise) 140/293 (47.8%) 140 142/293 (48.5%) 142 210/375 (56%) 210 41/78 (52.6%) 41
    Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L) 56/293 (19.1%) 56 55/293 (18.8%) 55 97/375 (25.9%) 97 14/78 (17.9%) 14
    Rigors/chills 71/293 (24.2%) 71 55/293 (18.8%) 55 56/375 (14.9%) 56 8/78 (10.3%) 8
    Immune system disorders
    Allergic reaction/hypersensitivity (including drug fever) 15/293 (5.1%) 15 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Infections and infestations
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood 23/293 (7.8%) 23 24/293 (8.2%) 24 47/375 (12.5%) 47 0/78 (0%) 0
    Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon 22/293 (7.5%) 22 26/293 (8.9%) 26 23/375 (6.1%) 23 0/78 (0%) 0
    Investigations
    ALT, SGPT (serum glutamic pyruvic transaminase) 124/293 (42.3%) 124 90/293 (30.7%) 90 137/375 (36.5%) 137 34/78 (43.6%) 34
    AST, SGOT (serum glutamic oxaloacetic transaminase) 126/293 (43%) 126 92/293 (31.4%) 92 121/375 (32.3%) 121 33/78 (42.3%) 33
    Alkaline phosphatase 79/293 (27%) 79 60/293 (20.5%) 60 84/375 (22.4%) 84 22/78 (28.2%) 22
    Bilirubin (hyperbilirubinemia) 51/293 (17.4%) 51 63/293 (21.5%) 63 75/375 (20%) 75 0/78 (0%) 0
    Creatinine 34/293 (11.6%) 34 19/293 (6.5%) 19 23/375 (6.1%) 23 0/78 (0%) 0
    Leukocytes (total WBC) 101/293 (34.5%) 101 97/293 (33.1%) 97 152/375 (40.5%) 152 40/78 (51.3%) 40
    Lymphopenia 32/293 (10.9%) 32 27/293 (9.2%) 27 50/375 (13.3%) 50 10/78 (12.8%) 10
    Metabolic/Laboratory-Other (Specify) 16/293 (5.5%) 16 0/293 (0%) 0 21/375 (5.6%) 21 0/78 (0%) 0
    Neutrophils/granulocytes (ANC/AGC) 109/293 (37.2%) 109 111/293 (37.9%) 111 195/375 (52%) 195 40/78 (51.3%) 40
    Platelets 136/293 (46.4%) 136 130/293 (44.4%) 130 227/375 (60.5%) 227 49/78 (62.8%) 49
    Metabolism and nutrition disorders
    Albumin, serum-low (hypoalbuminemia) 69/293 (23.5%) 69 53/293 (18.1%) 53 81/375 (21.6%) 81 6/78 (7.7%) 6
    Anorexia 85/293 (29%) 85 75/293 (25.6%) 75 76/375 (20.3%) 76 9/78 (11.5%) 9
    Calcium, serum-low (hypocalcemia) 44/293 (15%) 44 53/293 (18.1%) 53 44/375 (11.7%) 44 5/78 (6.4%) 5
    Glucose, serum-high (hyperglycemia) 79/293 (27%) 79 71/293 (24.2%) 71 97/375 (25.9%) 97 21/78 (26.9%) 21
    Magnesium, serum-low (hypomagnesemia) 17/293 (5.8%) 17 0/293 (0%) 0 25/375 (6.7%) 25 0/78 (0%) 0
    Phosphate, serum-low (hypophosphatemia) 17/293 (5.8%) 17 18/293 (6.1%) 18 0/375 (0%) 0 0/78 (0%) 0
    Potassium, serum-high (hyperkalemia) 20/293 (6.8%) 20 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Potassium, serum-low (hypokalemia) 55/293 (18.8%) 55 44/293 (15%) 44 61/375 (16.3%) 61 12/78 (15.4%) 12
    Sodium, serum-low (hyponatremia) 42/293 (14.3%) 42 41/293 (14%) 41 39/375 (10.4%) 39 8/78 (10.3%) 8
    Uric acid, serum-high (hyperuricemia) 0/293 (0%) 0 0/293 (0%) 0 20/375 (5.3%) 20 0/78 (0%) 0
    Musculoskeletal and connective tissue disorders
    Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized 0/293 (0%) 0 0/293 (0%) 0 0/375 (0%) 0 4/78 (5.1%) 4
    Pain - Bone 0/293 (0%) 0 15/293 (5.1%) 15 40/375 (10.7%) 40 8/78 (10.3%) 8
    Pain - Joint 0/293 (0%) 0 0/293 (0%) 0 21/375 (5.6%) 21 4/78 (5.1%) 4
    Pain - Muscle 0/293 (0%) 0 0/293 (0%) 0 19/375 (5.1%) 19 0/78 (0%) 0
    Nervous system disorders
    Dizziness 0/293 (0%) 0 0/293 (0%) 0 42/375 (11.2%) 42 0/78 (0%) 0
    Pain - Head/headache 72/293 (24.6%) 72 48/293 (16.4%) 48 94/375 (25.1%) 94 9/78 (11.5%) 9
    Taste alteration (dysgeusia) 18/293 (6.1%) 18 16/293 (5.5%) 16 0/375 (0%) 0 0/78 (0%) 0
    Psychiatric disorders
    Insomnia 0/293 (0%) 0 0/293 (0%) 0 25/375 (6.7%) 25 0/78 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 15/293 (5.1%) 15 0/293 (0%) 0 20/375 (5.3%) 20 0/78 (0%) 0
    Dyspnea (shortness of breath) 33/293 (11.3%) 33 20/293 (6.8%) 20 59/375 (15.7%) 59 0/78 (0%) 0
    Hemorrhage, pulmonary/upper respiratory - Nose 37/293 (12.6%) 37 24/293 (8.2%) 24 26/375 (6.9%) 26 6/78 (7.7%) 6
    Skin and subcutaneous tissue disorders
    Hair loss/Alopecia (scalp or body) 76/293 (25.9%) 76 98/293 (33.4%) 98 118/375 (31.5%) 118 8/78 (10.3%) 8
    Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) 53/293 (18.1%) 53 45/293 (15.4%) 45 85/375 (22.7%) 85 0/78 (0%) 0
    Pruritus/itching 0/293 (0%) 0 15/293 (5.1%) 15 20/375 (5.3%) 20 0/78 (0%) 0
    Rash/desquamation 51/293 (17.4%) 51 64/293 (21.8%) 64 62/375 (16.5%) 62 6/78 (7.7%) 6
    Vascular disorders
    Hemorrhage/Bleeding-Other (Specify) 27/293 (9.2%) 27 15/293 (5.1%) 15 29/375 (7.7%) 29 0/78 (0%) 0
    Hypertension 21/293 (7.2%) 21 0/293 (0%) 0 0/375 (0%) 0 0/78 (0%) 0
    Hypotension 17/293 (5.8%) 17 15/293 (5.1%) 15 28/375 (7.5%) 28 0/78 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title SWOG Leukemia Statistician
    Organization SWOG Statistical Office
    Phone 206-667-4408
    Email
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00085709
    Other Study ID Numbers:
    • S0106
    • U10CA032102
    • S0106
    First Posted:
    Jun 16, 2004
    Last Update Posted:
    Sep 30, 2015
    Last Verified:
    Sep 1, 2015