Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

218

Participants

Timeline

Start Date

January 15, 2008

Primary Completion Date

September 30, 2017

Study Completion Date

June 30, 2024

Conditions
Acute Lymphoblastic LeukemiaAcute Undifferentiated LeukemiaChildhood T Acute Lymphoblastic Leukemia
Interventions
DRUG

Asparaginase

Given IV, IM, or PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV or IT

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given IV or PO

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given IV or SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lestaurtinib

Given PO

DRUG

Leucovorin Calcium

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IV, IT, or PO

DRUG

Methylprednisolone

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Pegaspargase

Given IM

OTHER

Pharmacological Study

Correlative studies

DRUG

Prednisone

Given PO

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Vincristine Sulfate

Given IV

Trial Locations (170)

1145

Starship Children's Hospital, Grafton

6008

Princess Margaret Hospital for Children, Perth

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone, 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

11501

NYU Langone Hospital - Long Island, Mineola

12208

Albany Medical Center, Albany

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Penn State Children's Hospital, Hershey

17822

Geisinger Medical Center, Danville

19104

Children's Hospital of Philadelphia, 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

23507

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

25304

West Virginia University Charleston Division, Charleston

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

29605

BI-LO Charities Children's Cancer Center, Greenville

Greenville Cancer Treatment Center, Greenville

30322

Children's Healthcare of Atlanta - Egleston, 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

32610

University of Florida Health Science Center - Gainesville, Gainesville

32803

AdventHealth Orlando, Orlando

32806

Arnold Palmer Hospital for Children, Orlando

Nemours Children's Clinic - Orlando, Orlando

Orlando Health Cancer Institute, Orlando

32827

Nemours Children's Hospital, Orlando

33136

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

33176

Miami Cancer Institute, Miami

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

37232

Vanderbilt University/Ingram Cancer Center, Nashville

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

44106

Rainbow Babies and Childrens Hospital, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

46260

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48503

Hurley Medical Center, Flint

48824

Michigan State University Clinical Center, East Lansing

49007

Bronson Methodist Hospital, Kalamazoo

49008

Kalamazoo Center for Medical Studies, Kalamazoo

49503

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids

50309

Blank Children's Hospital, Des Moines

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

Marshfield Medical Center-Marshfield, Marshfield

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 Children's Hospital-Park Ridge, Park Ridge

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

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

65201

Columbia Regional, Columbia

68114

Children's Hospital and Medical Center of Omaha, Omaha

70112

Tulane University School of Medicine, 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

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

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

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

87106

University of New Mexico Cancer Center, Albuquerque

89135

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas

89144

Summerlin Hospital Medical Center, Las Vegas

89169

Nevada Cancer Research Foundation NCORP, Las Vegas

90048

Cedars Sinai Medical Center, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

90806

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

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

93636

Valley Children's Hospital, Madera

94143

UCSF Medical Center-Parnassus, San Francisco

94158

UCSF Medical Center-Mission Bay, 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

95817

University of California Davis Comprehensive Cancer Center, Sacramento

96813

University of Hawaii Cancer Center, Honolulu

96826

Kapiolani Medical Center for Women and Children, Honolulu

96859

Tripler Army Medical Center, Honolulu

97227

Legacy Emanuel Children's Hospital, Portland

Legacy Emanuel Hospital and Health Center, Portland

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

06106

Connecticut Children's Medical Center, Hartford

06520

Yale University, New Haven

04401

Eastern Maine Medical Center, Bangor

02111

Tufts Children's Hospital, Boston

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer 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

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

University of Vermont and State Agricultural College, Burlington

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

N6A 5W9

Children's 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

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT00557193 - Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter