Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

3,154

Participants

Timeline

Start Date

December 29, 2003

Primary Completion Date

December 31, 2010

Study Completion Date

March 31, 2021

Conditions
Acute Lymphoblastic LeukemiaAdult B Acute Lymphoblastic LeukemiaChildhood B Acute Lymphoblastic Leukemia
Interventions
DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT, SC, or IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT or IV

DRUG

Pegaspargase

Given IM

DRUG

Prednisone

Given PO or IV

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

Thioguanine

Given PO

DRUG

Vincristine Sulfate

Given IV

Trial Locations (234)

1011

Swiss Pediatric Oncology Group - Lausanne, Lausanne

1145

Starship Children's Hospital, Grafton

1205

Swiss Pediatric Oncology Group - Geneva, Geneva

3010

Swiss Pediatric Oncology Group - Bern, Bern

3052

Royal Children's Hospital, Parkville

4029

Royal Brisbane and Women's Hospital, Herston

Royal Children's Hospital-Brisbane, Herston

5006

Women's and Children's Hospital-Adelaide, North Adelaide

6002

Wellington Children's Hospital, Wellington

6008

Princess Margaret Hospital for Children, Perth

8011

Christchurch Hospital, Christchurch

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10029

Mount Sinai Hospital, New York

10065

NYP/Weill Cornell Medical Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10595

New York Medical College, Valhalla

11040

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

11201

Brooklyn Hospital Center, Brooklyn

11212

Brookdale Hospital Medical Center, Brooklyn

11219

Maimonides Medical Center, Brooklyn

11501

NYU Winthrop Hospital, Mineola

11794

Stony Brook University Medical Center, Stony Brook

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Children's Hospital, Hershey

17822

Geisinger Medical Center, Danville

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

19104

Children's Hospital of Philadelphia, Philadelphia

Children's Oncology Group, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20007

MedStar Georgetown University Hospital, Washington D.C.

20010

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

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21215

Sinai Hospital of Baltimore, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

22908

University of Virginia Cancer Center, Charlottesville

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

23507

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

24014

Carilion Children's, Roanoke

25304

West Virginia University Charleston Division, Charleston

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

Duke University Medical Center, Durham

27834

East Carolina University, Greenville

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28204

Novant Health Presbyterian Medical Center, Charlotte

28801

Mission Hospital, Asheville

29203

Prisma Health Richland Hospital, Columbia

29425

Medical University of South Carolina, Charleston

29605

BI-LO Charities Children's Cancer Center, Greenville

Greenville Cancer Treatment Center, Greenville

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

Emory University Hospital/Winship Cancer Institute, Atlanta

30912

Augusta University Medical Center, Augusta

31404

Memorial Health University Medical Center, Savannah

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32504

Nemours Children's Clinic - Pensacola, Pensacola

Sacred Heart Hospital, Pensacola

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32806

Nemours Children's Clinic - Orlando, Orlando

Orlando Health Cancer Institute, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood

33136

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33155

Nicklaus Children's Hospital, Miami

33176

Miami Cancer Institute, Miami

33316

Broward Health Medical Center, Fort Lauderdale

33407

Saint Mary's Hospital, West Palm Beach

33607

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33901

Lee Memorial Health System, Fort Myers

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

University of Alabama at Birmingham Cancer Center, Birmingham

36604

USA Health Strada Patient Care Center, Mobile

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37403

T C Thompson Children's Hospital, Chattanooga

37916

East Tennessee Childrens Hospital, Knoxville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Children's Hospital, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43205

Nationwide Children's Hospital, Columbus

43606

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo

43608

Mercy Children's Hospital, Toledo

43614

University of Toledo, Toledo

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

44501

Tod Children's Hospital - Forum Health, Youngstown

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

Riley Hospital for Children, Indianapolis

46260

Saint Vincent Hospital and Health Care Center, Indianapolis

48073

Beaumont Children's Hospital-Royal Oak, Royal Oak

William Beaumont Hospital-Royal Oak, Royal Oak

48109

C S Mott Children's Hospital, Ann Arbor

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48236

Ascension Saint John Hospital, Detroit

48503

Hurley Medical Center, Flint

49007

Bronson Methodist Hospital, Kalamazoo

49008

Kalamazoo Center for Medical Studies, Kalamazoo

49503

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids

Spectrum Health at Butterworth Campus, Grand Rapids

50309

Blank Children's Hospital, Des Moines

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

Marshfield Medical Center-Marshfield, Marshfield

54601

Gundersen Lutheran Medical Center, La Crosse

55102

Children's Hospital and Clinic-Saint Paul, Saint Paul

55404

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

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

58122

Sanford Broadway Medical Center, Fargo

60068

Advocate Lutheran General Hospital, Park Ridge

60153

Loyola University Medical Center, Maywood

60453

Advocate Children's Hospital-Oak Lawn, Oak Lawn

60611

Lurie Children's Hospital-Chicago, Chicago

60612

Rush University Medical Center, Chicago

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

62702

Southern Illinois University School of Medicine, Springfield

63104

Cardinal Glennon Children's Medical Center, St Louis

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

65201

Columbia Regional, Columbia

65212

University of Missouri - Ellis Fischel, Columbia

66160

University of Kansas Cancer Center, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Health Sciences Center, New Orleans

70118

Children's Hospital New Orleans, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

74136

Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa

75230

Medical City Dallas Hospital, Dallas

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

76508

Scott and White Memorial Hospital, Temple

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

M D Anderson Cancer Center, Houston

78229

Methodist Children's Hospital of South Texas, San Antonio

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

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

79106

Texas Tech University Health Sciences Center-Amarillo, Amarillo

79410

Covenant Children's Hospital, Lubbock

80045

Children's Hospital Colorado, Aurora

80218

Presbyterian - Saint Lukes Medical Center - Health One, Denver

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver

83712

Saint Luke's Cancer Institute - Boise, Boise

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

85202

Banner Children's at Desert, Mesa

85719

Banner University Medical Center - Tucson, Tucson

87102

University of New Mexico Cancer Center, Albuquerque

89169

Nevada Cancer Research Foundation NCORP, Las Vegas

90027

Children's Hospital Los Angeles, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90095

Mattel Children's Hospital UCLA, Los Angeles

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

90806

Miller Children's and Women's Hospital Long Beach, Long Beach

91010

City of Hope Comprehensive Cancer Center, Duarte

92123

Rady Children's Hospital - San Diego, San Diego

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

93102

Santa Barbara Cottage Hospital, Santa Barbara

93636

Valley Children's Hospital, Madera

94143

UCSF Medical Center-Parnassus, San Francisco

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

UCSF Benioff Children's Hospital Oakland, Oakland

94611

Kaiser Permanente-Oakland, Oakland

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96813

University of Hawaii Cancer Center, Honolulu

96859

Tripler Army Medical Center, Honolulu

97227

Legacy Emanuel Children's Hospital, Portland

Legacy Emanuel Hospital and Health Center, Portland

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

98405

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

Madigan Army Medical Center, Tacoma

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

72202-3591

Arkansas Children's Hospital, Little Rock

06030

University of Connecticut, Farmington

06106

Connecticut Children's Medical Center, Hartford

06520

Yale University, New Haven

04401

Eastern Maine Medical Center, Bangor

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02111

Tufts Children's Hospital, Boston

02114

Massachusetts General Hospital Cancer Center, Boston

01199

Baystate Medical Center, Springfield

01655

UMass Memorial Medical Center - University Campus, Worcester

48824-7016

Michigan State University Clinical Center, East Lansing

03756

Dartmouth Hitchcock Medical Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

07039

Saint Barnabas Medical Center, Livingston

07960

Morristown Medical Center, Morristown

08901

Saint Peter's University Hospital, New Brunswick

08903

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

07112

Newark Beth Israel Medical Center, Newark

07503

Saint Joseph's Regional Medical Center, Paterson

07902

Overlook Hospital, Summit

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

77555-0565

University of Texas Medical Branch, Galveston

05405

University of Vermont and State Agricultural College, Burlington

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

T3B 6A8

Alberta Children's Hospital, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

V6H 3V4

British Columbia Children's Hospital, Vancouver

R3E 0V9

CancerCare Manitoba, Winnipeg

A1B 3V6

Janeway Child Health Centre, St. John's

B3K 6R8

IWK Health Centre, Halifax

K7L 2V7

Kingston Health Sciences Centre, Kingston

N6A 5W9

Children's Hospital, London

N6K 1C2

Victoria Hospital, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

Hospital for Sick Children, Toronto

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00075725 - Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter