ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

ClinicalTrials.gov ID: NCT00372593

Public ClinicalTrials.gov record NCT00372593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 21, 2026, 2:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Study identification

NCT ID
NCT00372593
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Children's Oncology Group
Network
Enrollment
1,070 participants

Conditions and interventions

Conditions

Interventions

  • asparaginase Drug
  • cytarabine Drug
  • daunorubicin hydrochloride Drug
  • etoposide Drug
  • gemtuzumab ozogamicin Drug
  • mitoxantrone hydrochloride Drug

Drug

Eligibility (public fields only)

Age range
Up to 29 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2006
Primary completion
Jul 31, 2013
Completion
Sep 29, 2020
Last update posted
Mar 23, 2021

2006 – 2020

United States locations

U.S. sites
178
U.S. states
48
U.S. cities
144
Facility City State ZIP Site status
UAB Comprehensive Cancer Center Birmingham Alabama 35294
University of South Alabama Mitchell Cancer Institute Mobile Alabama 36604
Banner Desert Medical Center Mesa Arizona 85202
Phoenix Children's Hospital Phoenix Arizona 85016
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona 85724-5024
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas 72205
Southern California Permanente Medical Group Downey California 90242
City of Hope Comprehensive Cancer Center Duarte California 91010-3000
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California 92354
Childrens Hospital Los Angeles Los Angeles California 90027
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California 90048-1865
Jonsson Comprehensive Cancer Center at UCLA Los Angeles California 90095-1781
Children's Hospital Central California Madera California 93636-8762
Children's Hospital and Research Center Oakland Oakland California 94609
Kaiser Permanente Medical Center - Oakland Oakland California 94611
Children's Hospital of Orange County Orange California 92868-3874
Sutter Cancer Center Sacramento California 95816
University of California Davis Cancer Center Sacramento California 95817
Rady Children's Hospital - San Diego San Diego California 92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California 94115
Santa Barbara Cottage Children's Hospital Santa Barbara California 93105
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Torrance California 90502
Children's Hospital Center for Cancer and Blood Disorders Aurora Colorado 80045
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut 06360-2875
Yale Cancer Center New Haven Connecticut 06520-8028
Alfred I. duPont Hospital for Children Wilmington Delaware 19803
Children's National Medical Center Washington D.C. District of Columbia 20010-2970
Walter Reed Army Medical Center Washington D.C. District of Columbia 20307-5001
Broward General Medical Center Cancer Center Fort Lauderdale Florida 33316
Lee Cancer Care of Lee Memorial Health System Fort Myers Florida 33901
University of Florida Shands Cancer Center Gainesville Florida 32610-0232
Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida 33021
Nemours Children's Clinic Jacksonville Florida 32207-8426
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami Florida 33136
Miami Children's Hospital Miami Florida 33155
Baptist-South Miami Regional Cancer Program Miami Florida 33176
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida 32803-1273
M.D. Anderson Cancer Center at Orlando Orlando Florida 32806
Nemours Children's Clinic - Orlando Orlando Florida 32806
Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola Florida 32504
All Children's Hospital St. Petersburg Florida 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa Florida 33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach Florida 33407
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta Georgia 30322
Winship Cancer Institute of Emory University Atlanta Georgia 30322
MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia 30912
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia 31403-3089
Cancer Research Center of Hawaii Honolulu Hawaii 96813
Tripler Army Medical Center Tripler AMC Hawaii 96859-5000
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho 83712
University of Illinois Cancer Center Chicago Illinois 60612-7243
Children's Memorial Hospital - Chicago Chicago Illinois 60614
University of Chicago Cancer Research Center Chicago Illinois 60637-1470
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois 60153
Advocate Christ Medical Center Oak Lawn Illinois 60453-2699
Keyser Family Cancer Center at Advocate Hope Children's Hospital Oak Lawn Illinois 60453
Advocate Lutheran General Cancer Care Center Park Ridge Illinois 60068-1174
Simmons Cooper Cancer Institute Springfield Illinois 62794-9677
Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202-5289
St. Vincent Indianapolis Hospital Indianapolis Indiana 46260
Blank Children's Hospital Des Moines Iowa 50309
Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa 52242-1002
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas 66160-7357
Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky 40536-0093
Kosair Children's Hospital Louisville Kentucky 40232
Tulane Cancer Center Office of Clinical Research Alexandria Louisiana 71315-3198
Children's Hospital of New Orleans New Orleans Louisiana 70118
CancerCare of Maine at Eastern Maine Medical Center Bangor Maine 04401
Maine Children's Cancer Program at Barbara Bush Children's Hospital Portland Maine 04102
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland 21201
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore Maryland 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-2410
Floating Hospital for Children at Tufts - New England Medical Center Boston Massachusetts 02111
Massachusetts General Hospital Boston Massachusetts 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts 02115
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield Massachusetts 01199-0001
UMASS Memorial Cancer Center - University Campus Worcester Massachusetts 01655
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor Michigan 48109-0286
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-1379
Hurley Medical Center Flint Michigan 48503
Butterworth Hospital at Spectrum Health Grand Rapids Michigan 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236
CCOP - Kalamazoo Kalamazoo Michigan 49008
Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan 48910
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota 55404
Masonic Cancer Center at University of Minnesota Minneapolis Minnesota 55455
Mayo Clinic Cancer Center Rochester Minnesota 55905
University of Mississippi Cancer Clinic Jackson Mississippi 39216
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri 65203
Children's Mercy Hospital Kansas City Missouri 64108
Cardinal Glennon Children's Hospital St Louis Missouri 63104
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St Louis Missouri 63110
Children's Hospital Omaha Nebraska 68114-4113
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska 68198-6805
CCOP - Nevada Cancer Research Foundation Las Vegas Nevada 89106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756-0002
Hackensack University Medical Center Cancer Center Hackensack New Jersey 07601
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey 08903
Newark Beth Israel Medical Center Newark New Jersey 07112
St. Joseph's Hospital and Medical Center Paterson New Jersey 07503
Overlook Hospital Summit New Jersey 07902
University of New Mexico Cancer Center Albuquerque New Mexico 87131-5636
Albany Medical Center Hospital Albany New York 12208
Brooklyn Hospital Center Brooklyn New York 11201-5493
Roswell Park Cancer Institute Buffalo New York 14263-0001
Winthrop University Hospital Mineola New York 11501
Schneider Children's Hospital New Hyde Park New York 11040
NYU Cancer Institute at New York University Medical Center New York New York 10016
New York Weill Cornell Cancer Center at Cornell University New York New York 10021
Mount Sinai Medical Center New York New York 10029
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York 10032
Memorial Sloan-Kettering Cancer Center New York New York 10065
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York 14642
Stony Brook University Cancer Center Stony Brook New York 11794-9446
SUNY Upstate Medical University Hospital Syracuse New York 13210
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Bronx New York 10461
Mission Hospitals - Memorial Campus Asheville North Carolina 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina 28233-3549
Duke Comprehensive Cancer Center Durham North Carolina 27710
Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina 27834
Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina 27157-1096
CCOP - MeritCare Hospital Fargo North Dakota 58122
Akron Children's Hospital Akron Ohio 44308-1062
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229-3039
Rainbow Babies and Children's Hospital Cleveland Ohio 44106
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195
Nationwide Children's Hospital Columbus Ohio 43205-2696
Children's Medical Center - Dayton Dayton Ohio 45404
Toledo Hospital Toledo Ohio 43606
Medical University of Ohio Cancer Center Toledo Ohio 43614
Oklahoma University Cancer Institute Oklahoma City Oklahoma 73104
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon 97227
Knight Cancer Institute at Oregon Health and Science University Portland Oregon 97239-3098
Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania 18017
Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania 17033-0850
Penn State Children's Hospital Hershey Pennsylvania 17033-0850
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134-1095
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213
Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island 02903
Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina 29425
Palmetto Health South Carolina Cancer Center Columbia South Carolina 29203
Greenville Hospital Cancer Center Greenville South Carolina 29605
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota 57117-5039
T.C. Thompson Children's Hospital Chattanooga Tennessee 37403
East Tennessee Children's Hospital Knoxville Tennessee 37916
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6838
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas 79106
Dell Children's Medical Center of Central Texas Austin Texas 78723
Driscoll Children's Hospital Corpus Christi Texas 78411
Medical City Dallas Hospital Dallas Texas 75230
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas 75390
Cook Children's Medical Center - Fort Worth Fort Worth Texas 76104
Baylor University Medical Center - Houston Houston Texas 77030
Covenant Children's Hospital Lubbock Texas 79410
University of Texas Health Science Center at San Antonio San Antonio Texas 78229-3900
Methodist Children's Hospital of South Texas San Antonio Texas 78229-3993
CCOP - Scott and White Hospital Temple Texas 76508
Primary Children's Medical Center Salt Lake City Utah 84113-1100
Fletcher Allen Health Care - University Health Center Campus Burlington Vermont 05401
University of Virginia Cancer Center Charlottesville Virginia 22908
Inova Fairfax Hospital Falls Church Virginia 22042-3300
Children's Hospital of The King's Daughters Norfolk Virginia 23507
Naval Medical Center - Portsmouth Portsmouth Virginia 23708-2197
Virginia Commonwealth University Massey Cancer Center Richmond Virginia 23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital Roanoke Virginia 24014
Children's Hospital and Regional Medical Center - Seattle Seattle Washington 98105
Providence Cancer Center at Sacred Heart Medical Center Spokane Washington 99204
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma Washington 98405
Madigan Army Medical Center - Tacoma Tacoma Washington 98431
West Virginia University Health Sciences Center - Charleston Charleston West Virginia 25302
St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54307-3508
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison Wisconsin 53792-6164
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00372593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 23, 2021 · Synced May 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00372593 live on ClinicalTrials.gov.

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