A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,186

Participants

Timeline

Start Date

July 21, 2020

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Acute Myeloid Leukemia
Interventions
PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

DRUG

Asparaginase Erwinia chrysanthemi

Given IM or IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo BM aspiration

PROCEDURE

Bone Marrow Biopsy

BM biopsy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cytarabine

Given IV or IT

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexrazoxane Hydrochloride

Given IV

DRUG

Etoposide

Given IV

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET

DRUG

Gemtuzumab Ozogamicin

Given IV

DRUG

Gilteritinib Fumarate

Given PO/NG/G-tube

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Methotrexate

Given IT

DRUG

Mitoxantrone Hydrochloride

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Therapeutic Hydrocortisone

Given IT

Trial Locations (205)

2031

ACTIVE_NOT_RECRUITING

Sydney Children's Hospital, Randwick

2145

ACTIVE_NOT_RECRUITING

The Children's Hospital at Westmead, Westmead

4101

RECRUITING

Queensland Children's Hospital, South Brisbane

6009

ACTIVE_NOT_RECRUITING

Perth Children's Hospital, Perth

10016

RECRUITING

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

10029

SUSPENDED

Mount Sinai Hospital, New York

10032

RECRUITING

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

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

RECRUITING

NYP/Weill Cornell Medical Center, New York

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10595

RECRUITING

New York Medical College, Valhalla

11040

RECRUITING

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

11219

RECRUITING

Maimonides Medical Center, Brooklyn

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

11794

RECRUITING

Stony Brook University Medical Center, Stony Brook

12208

RECRUITING

Albany Medical Center, Albany

13210

RECRUITING

State University of New York Upstate Medical University, Syracuse

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

14642

RECRUITING

University of Rochester, Rochester

15224

RECRUITING

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

RECRUITING

Penn State Children's Hospital, Hershey

17822

RECRUITING

Geisinger Medical Center, Danville

18103

RECRUITING

Lehigh Valley Hospital-Cedar Crest, Allentown

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19134

RECRUITING

Saint Christopher's Hospital for Children, Philadelphia

19803

RECRUITING

Alfred I duPont Hospital for Children, Wilmington

20007

RECRUITING

MedStar Georgetown University Hospital, Washington D.C.

20010

RECRUITING

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

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

21215

RECRUITING

Sinai Hospital of Baltimore, Baltimore

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22042

RECRUITING

Inova Fairfax Hospital, Falls Church

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

23507

RECRUITING

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

24014

RECRUITING

Carilion Children's, Roanoke

25304

RECRUITING

West Virginia University Charleston Division, Charleston

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27710

RECRUITING

Duke University Medical Center, Durham

27834

RECRUITING

East Carolina University, Greenville

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28204

SUSPENDED

Novant Health Presbyterian Medical Center, Charlotte

28801

RECRUITING

Mission Hospital, Asheville

29203

RECRUITING

Prisma Health Richland Hospital, Columbia

29425

RECRUITING

Medical University of South Carolina, Charleston

29605

RECRUITING

BI-LO Charities Children's Cancer Center, Greenville

30329

RECRUITING

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

30912

RECRUITING

Augusta University Medical Center, Augusta

31404

RECRUITING

Memorial Health University Medical Center, Savannah

32207

RECRUITING

Nemours Children's Clinic-Jacksonville, Jacksonville

32504

RECRUITING

Nemours Children's Clinic - Pensacola, Pensacola

SUSPENDED

Sacred Heart Hospital, Pensacola

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

32803

RECRUITING

AdventHealth Orlando, Orlando

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

32827

RECRUITING

Nemours Children's Hospital, Orlando

33021

RECRUITING

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

33136

RECRUITING

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

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33316

ACTIVE_NOT_RECRUITING

Broward Health Medical Center, Fort Lauderdale

33407

RECRUITING

Saint Mary's Medical Center, West Palm Beach

33470

ACTIVE_NOT_RECRUITING

Palms West Radiation Therapy, Loxahatchee Groves

33606

RECRUITING

Tampa General Hospital, Tampa

33607

RECRUITING

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

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

33908

RECRUITING

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

RECRUITING

Children's Hospital of Alabama, Birmingham

36604

RECRUITING

USA Health Strada Patient Care Center, Mobile

37203

RECRUITING

The Children's Hospital at TriStar Centennial, Nashville

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

37403

RECRUITING

T C Thompson Children's Hospital, Chattanooga

37916

RECRUITING

East Tennessee Childrens Hospital, Knoxville

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40202

RECRUITING

Norton Children's Hospital, Louisville

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43205

RECRUITING

Nationwide Children's Hospital, Columbus

43606

RECRUITING

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

44106

RECRUITING

Rainbow Babies and Childrens Hospital, Cleveland

44195

RECRUITING

Cleveland Clinic Foundation, Cleveland

44308

RECRUITING

Children's Hospital Medical Center of Akron, Akron

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

RECRUITING

Dayton Children's Hospital, Dayton

46202

RECRUITING

Riley Hospital for Children, Indianapolis

46260

RECRUITING

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48073

RECRUITING

Corewell Health Children's, Royal Oak

48109

RECRUITING

C S Mott Children's Hospital, Ann Arbor

48201

RECRUITING

Children's Hospital of Michigan, Detroit

48236

ACTIVE_NOT_RECRUITING

Henry Ford Health Saint John Hospital, Detroit

48823

ACTIVE_NOT_RECRUITING

Michigan State University, East Lansing

49007

RECRUITING

Bronson Methodist Hospital, Kalamazoo

49503

RECRUITING

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

50309

RECRUITING

Blank Children's Hospital, Des Moines

52242

RECRUITING

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54301

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54449

SUSPENDED

Marshfield Medical Center-Marshfield, Marshfield

55404

RECRUITING

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

55455

RECRUITING

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

60068

RECRUITING

Advocate Children's Hospital-Park Ridge, Park Ridge

60153

RECRUITING

Loyola University Medical Center, Maywood

60453

RECRUITING

Advocate Children's Hospital-Oak Lawn, Oak Lawn

60611

RECRUITING

Lurie Children's Hospital-Chicago, Chicago

60612

RECRUITING

University of Illinois, Chicago

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

61637

RECRUITING

Saint Jude Midwest Affiliate, Peoria

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

63104

ACTIVE_NOT_RECRUITING

Cardinal Glennon Children's Medical Center, St Louis

63110

RECRUITING

Washington University School of Medicine, St Louis

63141

RECRUITING

Mercy Hospital Saint Louis, St Louis

64108

RECRUITING

Children's Mercy Hospitals and Clinics, Kansas City

65212

SUSPENDED

University of Missouri Children's Hospital, Columbia

68114

RECRUITING

Children's Hospital and Medical Center of Omaha, Omaha

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70118

RECRUITING

Children's Hospital New Orleans, New Orleans

70121

RECRUITING

Ochsner Medical Center Jefferson, New Orleans

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

75230

RECRUITING

Medical City Dallas Hospital, Dallas

75390

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76104

RECRUITING

Cook Children's Medical Center, Fort Worth

76508

RECRUITING

Scott and White Memorial Hospital, Temple

77030

RECRUITING

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

RECRUITING

M D Anderson Cancer Center, Houston

78207

RECRUITING

Children's Hospital of San Antonio, San Antonio

78229

RECRUITING

Methodist Children's Hospital of South Texas, San Antonio

RECRUITING

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

78411

RECRUITING

Driscoll Children's Hospital, Corpus Christi

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79905

RECRUITING

El Paso Children's Hospital, El Paso

80045

RECRUITING

Children's Hospital Colorado, Aurora

80218

RECRUITING

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

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

85016

RECRUITING

Phoenix Childrens Hospital, Phoenix

85202

RECRUITING

Banner Children's at Desert, Mesa

85719

RECRUITING

Banner University Medical Center - Tucson, Tucson

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

89102

SUSPENDED

University Medical Center of Southern Nevada, Las Vegas

89109

SUSPENDED

Sunrise Hospital and Medical Center, Las Vegas

89135

RECRUITING

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

89144

RECRUITING

Summerlin Hospital Medical Center, Las Vegas

89502

RECRUITING

Renown Regional Medical Center, Reno

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90095

RECRUITING

Mattel Children's Hospital UCLA, Los Angeles

90242

RECRUITING

Kaiser Permanente Downey Medical Center, Downey

90806

RECRUITING

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

91010

RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

92123

RECRUITING

Rady Children's Hospital - San Diego, San Diego

92354

RECRUITING

Loma Linda University Medical Center, Loma Linda

92868

RECRUITING

Children's Hospital of Orange County, Orange

93102

SUSPENDED

Santa Barbara Cottage Hospital, Santa Barbara

93636

RECRUITING

Valley Children's Hospital, Madera

94158

RECRUITING

UCSF Medical Center-Mission Bay, San Francisco

94304

RECRUITING

Lucile Packard Children's Hospital Stanford University, Palo Alto

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland, Oakland

94611

RECRUITING

Kaiser Permanente-Oakland, Oakland

95817

RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

96826

RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

97227

RECRUITING

Legacy Emanuel Children's Hospital, Portland

97239

RECRUITING

Oregon Health and Science University, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

98405

RECRUITING

Mary Bridge Children's Hospital and Health Center, Tacoma

98431

RECRUITING

Madigan Army Medical Center, Tacoma

99204

RECRUITING

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

72202-3591

RECRUITING

Arkansas Children's Hospital, Little Rock

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

06520

RECRUITING

Yale University, New Haven

04401

RECRUITING

Eastern Maine Medical Center, Bangor

04074

RECRUITING

Maine Children's Cancer Program, Scarborough

20889-5600

RECRUITING

Walter Reed National Military Medical Center, Bethesda

02111

ACTIVE_NOT_RECRUITING

Tufts Children's Hospital, Boston

02114

RECRUITING

Massachusetts General Hospital Cancer Center, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

01655

RECRUITING

UMass Memorial Medical Center - University Campus, Worcester

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07601

RECRUITING

Hackensack University Medical Center, Hackensack

07960

RECRUITING

Morristown Medical Center, Morristown

08901

RECRUITING

Saint Peter's University Hospital, New Brunswick

08903

RECRUITING

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

07112

RECRUITING

Newark Beth Israel Medical Center, Newark

07503

RECRUITING

Saint Joseph's Regional Medical Center, Paterson

02903

RECRUITING

Rhode Island Hospital, Providence

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05405

RECRUITING

University of Vermont and State Agricultural College, Burlington

23708-2197

RECRUITING

Naval Medical Center - Portsmouth, Portsmouth

T3B 6A8

RECRUITING

Alberta Children's Hospital, Calgary

T6G 2B7

RECRUITING

University of Alberta Hospital, Edmonton

V6H 3V4

RECRUITING

British Columbia Children's Hospital, Vancouver

R3E 0V9

RECRUITING

CancerCare Manitoba, Winnipeg

B3K 6R8

RECRUITING

IWK Health Centre, Halifax

L8N 3Z5

SUSPENDED

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

K7L 2V7

RECRUITING

Kingston Health Sciences Centre, Kingston

N6A 5W9

SUSPENDED

Children's Hospital, London

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

RECRUITING

Hospital for Sick Children, Toronto

H3H 1P3

RECRUITING

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine, Montreal

J1H 5N4

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke

S7N 0W8

RECRUITING

Jim Pattison Children's Hospital, Saskatoon

G1V 4G2

RECRUITING

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Québec

00926

RECRUITING

University Pediatric Hospital, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT04293562 - A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | Biotech Hunter | Biotech Hunter