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

PHASE3CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

March 31, 2010

Study Completion Date

August 31, 2014

Conditions
Leukemia
Interventions
DRUG

gemtuzumab ozogamicin

Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart

OTHER

observation

No treatment given

DRUG

Cytosine arabinoside

IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5

DRUG

Daunomycin

IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;

Trial Locations (279)

85

University Hospital of Linkoping, Linköping

17604

Lancaster General Hospital, Lancaster

18501

Mercy Hospital Cancer Center - Scranton, Scranton

18510

Hematology and Oncology Associates of Northeastern Pennsylvania, Scranton

18840

Guthrie Cancer Center at Guthrie Clinic Sayre, Sayre

25304

West Virginia University Health Sciences Center - Charleston, Charleston

26102

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital, Parkersburg

28139

Rutherford Hospital, Rutherfordton

28501

Kinston Medical Specialists, Kinston

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

29501

McLeod Regional Medical Center, Florence

29621

AnMed Cancer Center, Anderson

31208

Medical Center of Central Georgia, Macon

31701

Phoebe Cancer Center at Phoebe Putney Memorial Hospital, Albany

33805

Center for Cancer Care and Research at Watson Clinic, LLP, Lakeland

39216

University of Mississippi Cancer Clinic, Jackson

43015

Grady Memorial Hospital, Delaware

43055

Licking Memorial Cancer Care Program at Licking Memorial Hospital, Newark

43081

Mount Carmel St. Ann's Cancer Center, Westerville

43130

Fairfield Medical Center, Lancaster

43215

CCOP - Columbus, Columbus

Grant Medical Center Cancer Care, Columbus

43222

Mount Carmel Health - West Hospital, Columbus

43228

Doctors Hospital at Ohio Health, Columbus

43311

Mary Rutan Hospital, Bellefontaine

43701

Genesis - Good Samaritan Hospital, Zanesville

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44708

Mercy Cancer Center at Mercy Medical Center, Canton

45177

Clinton Memorial Hospital, Wilmington

45385

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

David L. Rike Cancer Center at Miami Valley Hospital, Dayton

45429

CCOP - Dayton, Dayton

Charles F. Kettering Memorial Hospital, Kettering

45504

Mercy Medical Center, Springfield

45505

Community Hospital of Springfield and Clark County, Springfield

45601

Adena Regional Medical Center, Chillicothe

45750

Strecker Cancer Center at Marietta Memorial Hospital, Marietta

45801

St. Rita's Medical Center, Lima

45840

Blanchard Valley Medical Associates, Findlay

46107

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove

47374

Reid Hospital & Health Care Services, Richmond

48060

Mercy Regional Cancer Center at Mercy Hospital, Port Huron

48075

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield

48093

St. John Macomb Hospital, Warren

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48154

St. Mary Mercy Hospital, Livonia

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

48236

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

48503

Genesys Hurley Cancer Institute, Flint

Hurley Medical Center, Flint

48601

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49017

Battle Creek Health System Cancer Care Center, Battle Creek

49201

Foote Memorial Hospital, Jackson

49307

Mecosta County Medical Center, Big Rapids

49443

Mercy General Health Partners, Muskegon

49503

Butterworth Hospital at Spectrum Health, Grand Rapids

CCOP - Grand Rapids, Grand Rapids

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids

49519

Metro Health Hospital, Wyoming

49684

Munson Medical Center, Traverse City

50010

McFarland Clinic, PC, Ames

50307

Mercy Capitol Hospital, Des Moines

50309

CCOP - Iowa Oncology Research Association, Des Moines

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines

50314

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines

50316

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines

51101

Siouxland Hematology-Oncology Associates, LLP, Sioux City

51104

Mercy Medical Center - Sioux City, Sioux City

St. Luke's Regional Medical Center, Sioux City

52803

Genesis Regional Cancer Center at Genesis Medical Center, Davenport

52804

Genesis Medical Center - West Campus, Davenport

53188

Waukesha Memorial Hospital Regional Cancer Center, Waukesha

53226

Froedtert Hospital and Medical College of Wisconsin, Milwaukee

Medical College of Wisconsin Cancer Center, Milwaukee

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54303

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay

St. Mary's Hospital Medical Center - Green Bay, Green Bay

54449

Marshfield Clinic - Marshfield Center, Marshfield

54476

Marshfield Clinic - Weston Center, Weston

54494

Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids

54548

Marshfield Clinic - Lakeland Center, Minocqua

54701

Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire

54729

Marshfield Clinic - Chippewa Center, Chippewa Falls

54868

Marshfield Clinic - Indianhead Center, Rice Lake

55805

CCOP - Duluth, Duluth

Miller - Dwan Medical Center, Duluth

57105

Avera Cancer Institute, Sioux Falls

Medical X-Ray Center, PC, Sioux Falls

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

Sletten Cancer Institute at Benefis Healthcare, Great Falls

Great Falls

59501

Northern Montana Hospital, Havre

59601

St. Peter's Hospital, Helena

59701

St. James Healthcare Cancer Care, Butte

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

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

61350

Community Hospital of Ottawa, Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa

61354

Illinois Valley Community Hospital, Peru

61356

Perry Memorial Hospital, Princeton

61362

St. Margaret's Hospital, Spring Valley

61401

Galesburg Clinic, PC, Galesburg

Galesburg Cottage Hospital, Galesburg

61455

McDonough District Hospital, Macomb

61520

Graham Hospital, Canton

61530

Eureka Community Hospital, Eureka

61554

Cancer Treatment Center at Pekin Hospital, Pekin

61614

Proctor Hospital, Peoria

61615

CCOP - Illinois Oncology Research Association, Peoria

Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF St. Francis Medical Center, Peoria

61701

St. Joseph Medical Center, Bloomington

61747

Hopedale Medical Complex, Hopedale

61761

BroMenn Regional Medical Center, Normal

Community Cancer Center, Normal

62002

Saint Anthony's Hospital at Saint Anthony's Health Center, Alton

62321

Memorial Hospital, Carthage

62526

Decatur Memorial Hospital Cancer Care Institute, Decatur

62644

Mason District Hospital, Havana

62864

Good Samaritan Regional Health Center, Mount Vernon

63109

Midwest Hematology Oncology Group, Incorporated, St Louis

63141

CCOP - St. Louis-Cape Girardeau, St Louis

David C. Pratt Cancer Center at St. John's Mercy, St Louis

63701

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau

63703

Saint Francis Medical Center, Cape Girardeau

64050

Independence Regional Health Center, Independence

64068

Liberty Hospital, Liberty

64108

Truman Medical Center - Hospital Hill, Kansas City

64111

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City

64114

St. Joseph Medical Center, Kansas City

64116

North Kansas City Hospital, Kansas City

Parvin Radiation Oncology, Kansas City

64131

CCOP - Kansas City, Kansas City

64132

Research Medical Center, Kansas City

64506

Heartland Regional Medical Center, Saint Joseph

66044

Lawrence Memorial Hospital, Lawrence

66204

Shawnee Mission Medical Center, Shawnee Mission

66209

Menorah Medical Center, Overland Park

66606

Cotton-O'Neil Cancer Center, Topeka

66720

Cancer Center of Kansas, PA - Chanute, Chanute

67042

Cancer Center of Kansas, PA - El Dorado, El Dorado

Cancer Center of Kansas, PA - Salina, Salina

67068

Cancer Center of Kansas, PA - Kingman, Kingman

67114

Cancer Center of Kansas, PA - Newton, Newton

67124

Cancer Center of Kansas, PA - Pratt, Pratt

67152

Cancer Center of Kansas, PA - Wellington, Wellington

67156

Cancer Center of Kansas, PA - Winfield, Winfield

67208

Associates in Womens Health, PA - North Review, Wichita

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita

67214

Cancer Center of Kansas, PA - Wichita, Wichita

CCOP - Wichita, Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita

Wesley Medical Center, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas, PA - Parsons, Parsons

67801

Cancer Center of Kansas, PA - Dodge City, Dodge City

67901

Southwest Medical Center, Liberal

68114

Methodist Estabrook Cancer Center, Omaha

70112

MBCCOP - LSU Health Sciences Center, New Orleans

Medical Center of Louisiana - New Orleans, New Orleans

70806

Pennington Cancer Center at Baton Rouge General, Baton Rouge

70809

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

72205

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

72903

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith

78229

Cancer Therapy and Research Center, San Antonio

University Hospital - San Antonio, San Antonio

82801

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan

84003

American Fork Hospital, American Fork

84103

LDS Hospital, Salt Lake City

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84403

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center - Provo, Provo

84720

Sandra L. Maxwell Cancer Center, Cedar City

84770

Dixie Regional Medical Center - East Campus, St. George

87505

New Mexico Cancer Care Associates, Santa Fe

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89109

Sunrise Hospital and Medical Center, Las Vegas

94010

Peninsula Medical Center, Burlingame

94118

California Pacific Medical Center - California Campus, San Francisco

94589

Sutter Solano Medical Center, Vallejo

94704

Alta Bates Summit Comprehensive Cancer Center, Berkeley

94904

Marin Cancer Institute at Marin General Hospital, Greenbrae

Sutter Health - Western Division Cancer Research Group, Greenbrae

98002

Auburn Regional Center for Cancer Care, Auburn

98003

St. Francis Hospital, Federal Way

98104

Fred Hutchinson Cancer Research Center, Seattle

Harborview Medical Center, Seattle

98112

Group Health Central Hospital, Seattle

98122

Polyclinic First Hill, Seattle

98225

St. Joseph Cancer Center, Bellingham

98310

Olympic Hematology and Oncology, Bremerton

98372

Good Samaritan Cancer Center, Puyallup

98405

Allenmore Hospital, Tacoma

CCOP - Northwest, Tacoma

MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma

98431

Madigan Army Medical Center - Tacoma, Tacoma

98499

St. Clare Hospital, Tacoma

99202

Cancer Care Northwest - Spokane South, Spokane

99336

Columbia Basin Hematology, Kennewick

99508

Providence Cancer Center, Anchorage

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

62781-0001

Regional Cancer Center at Memorial Medical Center, Springfield

40536-0093

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

71315-3198

Tulane Cancer Center Office of Clinical Research, Alexandria

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber/Brigham and Women's Cancer Center, Boston

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

02135-2997

Caritas St. Elizabeth's Medical Center, Brighton

48106-0995

Saint Joseph Mercy Cancer Center, Ann Arbor

48109-0942

University of Michigan Comprehensive Cancer Center, Ann Arbor

48123-2500

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49007-3731

West Michigan Cancer Center, Kalamazoo

48912-1811

Sparrow Regional Cancer Center, Lansing

48341-2985

St. Joseph Mercy Oakland, Pontiac

55805-1983

Duluth Clinic Cancer Center - Duluth, Duluth

59107-7000

Billings Clinic - Downtown, Billings

59405-5309

Big Sky Oncology, Great Falls

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

68198-6805

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

87131-5636

University of New Mexico Cancer Center, Albuquerque

28233-3549

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte

44710-1799

Aultman Cancer Center at Aultman Hospital, Canton

43214-3998

Riverside Methodist Hospital Cancer Care, Columbus

45005-1066

Middletown Regional Hospital, Franklin

45373-1300

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

57117-5039

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls

78229-3900

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

98531-9027

Providence Centralia Hospital, Centralia

98506-5166

Providence St. Peter Hospital Regional Cancer Center, Olympia

98122-4307

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle

98195-6043

University Cancer Center at University of Washington Medical Center, Seattle

98405-3004

Franciscan Cancer Center at St. Joseph Medical Center, Tacoma

54301-3526

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

T6G 1Z2

Cross Cancer Institute at University of Alberta, Edmonton

V6T 1Z4

University of British Columbia, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

E1C 6Z8

Moncton Hospital, Moncton

B3H 1V8

Nova Scotia Cancer Centre, Halifax

L8V 5C2

Margaret and Charles Juravinski Cancer Centre, Hamilton

K7L 5P9

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

P7B 6V4

Cancer Care Program at Thunder Bay Regional Health Sciences, Thunder Bay

M5G 2M9

Princess Margaret Hospital, Toronto

J4V 2H1

Hopital Charles Lemoyne, Greenfield Park

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

H2W 1S6

McGill Cancer Centre at McGill University, Montreal

G1S 4L8

Hopital du Saint-Sacrement - Quebec, Québec

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

S7N 4H4

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon

413 45

Sahlgrenska University Hospital, Gothenburg

SE-141 86

Karolinska University Hospital - Huddinge, Huddinge

S-221 00

Lund University Hospital, Lund

SE-700

Orebro University Hospital, Örebro

171 76

Karolinska University Hospital - Solna, Stockholm

SE-85186

Sundsvall Hospital, Sundsvalls

Unknown

Uppsala University Hospital, Uppsala

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

SWOG Cancer Research Network

NETWORK

NCT00085709 - S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML | Biotech Hunter | Biotech Hunter