Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

April 1, 2017

Primary Completion Date

September 30, 2020

Study Completion Date

December 31, 2024

Conditions
Acute Leukemia of Ambiguous LineageB Acute Lymphoblastic LeukemiaMixed Phenotype Acute Leukemia
Interventions
DRUG

Azacitidine

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV, SC, IT

DRUG

Daunorubicin

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO, NG, IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Hydrocortisone Sodium Succinate

Given IT

DRUG

Leucovorin

Given PO, IV

DRUG

Leucovorin Calcium

Given PO, IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mercaptopurine

Given PO, NG

DRUG

Methotrexate

Given IT, IV, PO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

DRUG

Pegaspargase

Given IV

DRUG

Prednisolone

Given PO, NG

DRUG

Thioguanine

Given PO, NG

DRUG

Vincristine

Given IV

DRUG

Vincristine Sulfate

Given IV

Trial Locations (170)

6008

Princess Margaret Hospital for Children, Perth

6009

Perth Children's Hospital, Perth

10016

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

10029

Mount Sinai Hospital, New York

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

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

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

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

18017

Lehigh Valley Hospital - Muhlenberg, Bethlehem

18103

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

Children's Hospital of Philadelphia, Philadelphia

19134

Saint Christopher's Hospital for Children, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

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

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

24014

Carilion Children's, Roanoke

25304

West Virginia University Charleston Division, Charleston

26506

West Virginia University Healthcare, Morgantown

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

28801

Mission Hospital, Asheville

29203

Prisma Health Richland Hospital, Columbia

29605

BI-LO Charities Children's Cancer Center, Greenville

30329

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta

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

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

33407

Saint Mary's Medical Center, West Palm Beach

33607

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

33701

Johns Hopkins All Children's Hospital, St. Petersburg

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

36604

USA Health Strada Patient Care Center, Mobile

37203

The Children's Hospital at TriStar Centennial, Nashville

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

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

48073

Corewell Health Children's, Royal Oak

48109

C S Mott Children's Hospital, Ann Arbor

48236

Henry Ford Health Saint John Hospital, Detroit

48824

Michigan State University Clinical Center, East Lansing

49007

Bronson Methodist Hospital, Kalamazoo

49503

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, 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 Carbone Cancer Center - University Hospital, Madison

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

Marshfield Medical Center-Marshfield, Marshfield

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

58122

Sanford Broadway Medical Center, Fargo

60068

Advocate Children's Hospital-Park Ridge, 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

61637

Saint Jude Midwest Affiliate, Peoria

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

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

65212

University of Missouri Children's Hospital, Columbia

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

70118

Children's Hospital New Orleans, New Orleans

70121

Ochsner Medical Center Jefferson, New Orleans

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

78207

Children's Hospital of San Antonio, San Antonio

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

79410

Covenant Children's Hospital, Lubbock

79415

UMC Cancer Center / UMC Health System, Lubbock

79905

El Paso Children's Hospital, El Paso

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

85202

Banner Children's at Desert, Mesa

89102

University Medical Center of Southern Nevada, Las Vegas

89109

Sunrise Hospital and Medical Center, Las Vegas

89135

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

89144

Summerlin Hospital Medical Center, Las Vegas

90027

Children's Hospital Los Angeles, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

93636

Valley Children's Hospital, Madera

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

96826

Kapiolani Medical Center for Women and Children, Honolulu

97227

Legacy Emanuel Children's Hospital, Portland

98105

Seattle Children's Hospital, Seattle

99204

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

99508

Providence Alaska Medical Center, Anchorage

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

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02111

Tufts Children's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

01655

UMass Memorial Medical Center - University Campus, Worcester

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

Hackensack University Medical Center, Hackensack

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

02903

Rhode Island Hospital, Providence

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

University of Vermont and State Agricultural College, Burlington

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

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

00726

HIMA San Pablo Oncologic Hospital, Caguas

00912

San Jorge Children's Hospital, San Juan

00926

University Pediatric Hospital, San Juan

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02828358 - Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement | Biotech Hunter | Biotech Hunter