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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,070

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2020

Conditions
Leukemia
Interventions
DRUG

asparaginase

Given intramuscularly

DRUG

cytarabine

Given IV

DRUG

daunorubicin hydrochloride

Given IV over 6 hours

DRUG

etoposide

Given IV over 1-4 hours

DRUG

gemtuzumab ozogamicin

Given IV over 2 hours

DRUG

mitoxantrone hydrochloride

Given IV over 1 hour

Trial Locations (198)

1145

Starship Children's Health, Grafton

1205

Swiss Pediatric Oncology Group Geneva, Geneva

2145

Westmead Institute for Cancer Research at Westmead Hospital, Westmead

3010

Swiss Pediatric Oncology Group Bern, Bern

4029

Royal Children's Hospital, Herston

5006

Women's and Children's Hospital, North Adelaide

6001

Princess Margaret Hospital for Children, Perth

8011

Christchurch Hospital, Christchurch

10016

NYU Cancer Institute at New York University Medical Center, New York

10021

New York Weill Cornell Cancer Center at Cornell University, New York

10029

Mount Sinai Medical Center, New York

10032

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

10461

Albert Einstein Cancer Center at Albert Einstein College of Medicine, The Bronx

11040

Schneider Children's Hospital, New Hyde Park

11501

Winthrop University Hospital, Mineola

12208

Albany Medical Center Hospital, Albany

13210

SUNY Upstate Medical University Hospital, Syracuse

14642

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester

15213

Children's Hospital of Pittsburgh, Pittsburgh

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I. duPont Hospital for Children, Wilmington

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

21215

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23507

Children's Hospital of The King's Daughters, Norfolk

24014

Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke

25302

West Virginia University Health Sciences Center - Charleston, Charleston

27710

Duke Comprehensive Cancer Center, Durham

27834

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville

28801

Mission Hospitals - Memorial Campus, Asheville

29203

Palmetto Health South Carolina Cancer Center, Columbia

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29605

Greenville Hospital Cancer Center, Greenville

30322

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta

Winship Cancer Institute of Emory University, Atlanta

30912

MBCCOP - Medical College of Georgia Cancer Center, Augusta

32504

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola

32806

M.D. Anderson Cancer Center at Orlando, Orlando

Nemours Children's Clinic - Orlando, Orlando

33021

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

33155

Miami Children's Hospital, Miami

33176

Baptist-South Miami Regional Cancer Program, Miami

33316

Broward General Medical Center Cancer Center, Fort Lauderdale

33407

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach

33607

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa

33701

All Children's Hospital, St. Petersburg

33901

Lee Cancer Care of Lee Memorial Health System, Fort Myers

35294

UAB Comprehensive Cancer Center, Birmingham

36604

University of South Alabama Mitchell Cancer Institute, Mobile

37403

T.C. Thompson Children's Hospital, Chattanooga

37916

East Tennessee Children's Hospital, Knoxville

39216

University of Mississippi Cancer Clinic, Jackson

40232

Kosair Children's Hospital, Louisville

43606

Toledo Hospital, Toledo

43614

Medical University of Ohio Cancer Center, Toledo

44106

Rainbow Babies and Children's Hospital, Cleveland

44195

Cleveland Clinic Taussig Cancer Center, Cleveland

45404

Children's Medical Center - Dayton, Dayton

46260

St. Vincent Indianapolis Hospital, Indianapolis

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Hurley Medical Center, Flint

48910

Breslin Cancer Center at Ingham Regional Medical Center, Lansing

49008

CCOP - Kalamazoo, Kalamazoo

49503

Butterworth Hospital at Spectrum Health, Grand Rapids

50309

Blank Children's Hospital, Des Moines

53226

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee

54449

Marshfield Clinic - Marshfield Center, Marshfield

55404

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

55905

Mayo Clinic Cancer Center, Rochester

58122

CCOP - MeritCare Hospital, Fargo

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

60453

Keyser Family Cancer Center at Advocate Hope Children's Hospital, Oak Lawn

60614

Children's Memorial Hospital - Chicago, Chicago

63104

Cardinal Glennon Children's Hospital, St Louis

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

64108

Children's Mercy Hospital, Kansas City

65203

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia

70118

Children's Hospital of New Orleans, New Orleans

72205

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock

73104

Oklahoma University Cancer Institute, Oklahoma City

75230

Medical City Dallas Hospital, Dallas

75390

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas

76104

Cook Children's Medical Center - Fort Worth, Fort Worth

76508

CCOP - Scott and White Hospital, Temple

77030

Baylor University Medical Center - Houston, Houston

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

79106

Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo

79410

Covenant Children's Hospital, Lubbock

80045

Children's Hospital Center for Cancer and Blood Disorders, Aurora

83712

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise

85016

Phoenix Children's Hospital, Phoenix

85202

Banner Desert Medical Center, Mesa

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

90027

Childrens Hospital Los Angeles, Los Angeles

90242

Southern California Permanente Medical Group, Downey

90502

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Torrance

92354

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda

93105

Santa Barbara Cottage Children's Hospital, Santa Barbara

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94609

Children's Hospital and Research Center Oakland, Oakland

94611

Kaiser Permanente Medical Center - Oakland, Oakland

95816

Sutter Cancer Center, Sacramento

95817

University of California Davis Cancer Center, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

97227

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland

98105

Children's Hospital and Regional Medical Center - Seattle, Seattle

98405

Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma

98431

Madigan Army Medical Center - Tacoma, Tacoma

99204

Providence Cancer Center at Sacred Heart Medical Center, Spokane

85724-5024

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson

91010-3000

City of Hope Comprehensive Cancer Center, Duarte

90048-1865

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles

90095-1781

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles

93636-8762

Children's Hospital Central California, Madera

92868-3874

Children's Hospital of Orange County, Orange

92123-4282

Rady Children's Hospital - San Diego, San Diego

06360-2875

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington

06520-8028

Yale Cancer Center, New Haven

20010-2970

Children's National Medical Center, Washington D.C.

20307-5001

Walter Reed Army Medical Center, Washington D.C.

32610-0232

University of Florida Shands Cancer Center, Gainesville

32207-8426

Nemours Children's Clinic, Jacksonville

32803-1273

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando

31403-3089

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah

96859-5000

Tripler Army Medical Center, Tripler AMC

60612-7243

University of Illinois Cancer Center, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

60453-2699

Advocate Christ Medical Center, Oak Lawn

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

62794-9677

Simmons Cooper Cancer Institute, Springfield

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

52242-1002

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

66160-7357

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City

40536-0093

Lucille P. Markey Cancer Center at University of Kentucky, Lexington

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

04401

CancerCare of Maine at Eastern Maine Medical Center, Bangor

04102

Maine Children's Cancer Program at Barbara Bush Children's Hospital, Portland

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

02111

Floating Hospital for Children at Tufts - New England Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston

01199-0001

Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield

01655

UMASS Memorial Cancer Center - University Campus, Worcester

48109-0286

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

68114-4113

Children's Hospital, Omaha

68198-6805

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

07601

Hackensack University Medical Center Cancer Center, Hackensack

08903

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

07503

St. Joseph's Hospital and Medical Center, Paterson

07902

Overlook Hospital, Summit

87131-5636

University of New Mexico Cancer Center, Albuquerque

11201-5493

Brooklyn Hospital Center, Brooklyn

14263-0001

Roswell Park Cancer Institute, Buffalo

11794-9446

Stony Brook University Cancer Center, Stony Brook

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

28232-2861

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

27157-1096

Wake Forest University Comprehensive Cancer Center, Winston-Salem

44308-1062

Akron Children's Hospital, Akron

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

43205-2696

Nationwide Children's Hospital, Columbus

97239-3098

Knight Cancer Institute at Oregon Health and Science University, Portland

17822-0001

Geisinger Cancer Institute at Geisinger Health, Danville

17033-0850

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey

Penn State Children's Hospital, Hershey

19134-1095

St. Christopher's Hospital for Children, Philadelphia

02903

Rhode Island Hospital Comprehensive Cancer Center, Providence

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

37232-6838

Vanderbilt-Ingram Cancer Center, Nashville

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

78229-3993

Methodist Children's Hospital of South Texas, San Antonio

84113-1100

Primary Children's Medical Center, Salt Lake City

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

22042-3300

Inova Fairfax Hospital, Falls Church

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

23298-0037

Virginia Commonwealth University Massey Cancer Center, Richmond

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

53792-6164

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison

V6H 3V4

Children's & Women's Hospital of British Columbia, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Janeway Children's Health and Rehabilitation Centre, St. John's

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

N6A 5W9

Children's Hospital of Western Ontario, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3T 1C5

Hopital Sainte Justine, Montreal

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

00912

San Jorge Children's Hospital, Santurce

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00372593 - Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter