Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

657

Participants

Timeline

Start Date

December 19, 2002

Primary Completion Date

March 31, 2009

Study Completion Date

December 31, 2019

Conditions
Leukemia
Interventions
BIOLOGICAL

sargramostim

Given IV or as an injection

DRUG

busulfan

Given IV

DRUG

cyclophosphamide

Given IV

DRUG

cytarabine

Given as a continuous infusion

DRUG

gemtuzumab ozogamicin (GO)

Given IV

DRUG

Daunorubicin

Given intravenously daily for 3 days at a dose of either 45 or 90 mg/m2.

PROCEDURE

Autologous HCT

Autologous hematopoietic cell transplantation

PROCEDURE

Allogeneic HCT

Allogeneic hematopoietic cell transplantation

Trial Locations (99)

10016

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

10461

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

15232

UPMC Cancer Centers, Pittsburgh

16801

Geisinger Medical Group - Scenery Park, State College

18711

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre

30322

Winship Cancer Institute of Emory University, Atlanta

31096

Rambam Medical Center, Haifa

33136

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami

33428

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West, Boca Raton

33486

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus, Boca Raton

35294

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham

44708

Mercy Cancer Center at Mercy Medical Center, Canton

45236

Jewish Hospital Cancer Center, Cincinnati

45801

St. Rita's Medical Center, Lima

46815

Fort Wayne Medical Oncology and Hematology, Fort Wayne

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

54449

Marshfield Clinic - Marshfield Center, Marshfield

Saint Joseph's Hospital, Marshfield

54476

Marshfield Clinic - Weston Center, Weston

54501

Ministry Medical Group at Saint Mary's Hospital, Rhinelander

54601

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse

54701

Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire

55102

United Hospital, Saint Paul

55109

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55125

Minnesota Oncology Hematology, PA - Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

Park Nicollet Cancer Center, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55905

Mayo Clinic Cancer Center, Rochester

56601

MeritCare Bemidji, Bemidji

58122

CCOP - MeritCare Hospital, Fargo

MeritCare Broadway, Fargo

59101

CCOP - Montana Cancer Consortium, Billings

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings

Northern Rockies Radiation Oncology Center, Billings

St. Vincent Healthcare Cancer Care Services, Billings

59405

Great Falls Clinic - Main Facility, Great Falls

Great Falls Clinic, Great Falls

59601

St. Peter's Hospital, Helena

59701

St. James Healthcare Cancer Care, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

59801

Community Medical Center, Missoula

59804

Guardian Oncology and Center for Wellness, Missoula

59807

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula

59901

Glacier Oncology, PLLC, Kalispell

Kalispell Medical Oncology at KRMC, Kalispell

Kalispell Regional Medical Center, Kalispell

60048

North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville

60076

Hematology Oncology Associates - Skokie, Skokie

60432

Midwest Center for Hematology/Oncology, Joliet

60435

Joliet Oncology-Hematology Associates, Limited - West, Joliet

60563

La Grange Oncology Associates - Geneva, Naperville

60611

Hematology and Oncology Associates, Chicago

60714

Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles

61801

Carle Cancer Center at Carle Foundation Hospital, Urbana

CCOP - Carle Cancer Center, Urbana

80012

Aurora Presbyterian Hospital, Aurora

80033

Exempla Lutheran Medical Center, Wheat Ridge

80110

Swedish Medical Center, Englewood

80124

Sky Ridge Medical Center, Lone Tree

80204

St. Anthony Central Hospital, Denver

80210

Porter Adventist Hospital, Denver

80218

Presbyterian - St. Luke's Medical Center, Denver

St. Joseph Hospital, Denver

80220

Rose Medical Center, Denver

80229

North Suburban Medical Center, Thornton

80502

Hope Cancer Care Center at Longmont United Hospital, Longmont

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

80933

Penrose Cancer Center at Penrose Hospital, Colorado Springs

81004

St. Mary - Corwin Regional Medical Center, Pueblo

81502

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction

82801

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan

85259-5499

Mayo Clinic Scottsdale, Scottsdale

80224-2522

CCOP - Colorado Cancer Research Program, Denver

32610-0232

University of Florida Shands Cancer Center, Gainesville

60611-3013

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

60201-1781

Evanston Northwestern Healthcare - Evanston Hospital, Evanston

60068-1174

Advocate Lutheran General Cancer Care Center, Park Ridge

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

02111

Tufts-NEMC Cancer Center, Boston

49007-3731

West Michigan Cancer Center, Kalamazoo

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

59107-7000

Billings Clinic - Downtown, Billings

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

44710-1799

Aultman Cancer Center at Aultman Hospital, Canton

17822-0001

Geisinger Cancer Institute at Geisinger Health, Danville

17033-0850

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

19104-4283

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

37232-6838

Vanderbilt-Ingram Cancer Center, Nashville

23298-0037

Virginia Commonwealth University Massey Cancer Center, Richmond

53792-6164

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

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Eastern Cooperative Oncology Group

NETWORK

NCT00049517 - Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia | Biotech Hunter | Biotech Hunter