Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

July 21, 2015

Primary Completion Date

October 31, 2020

Study Completion Date

September 22, 2025

Conditions
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Interventions
DRUG

Arsenic Trioxide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Mitoxantrone Hydrochloride

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Tretinoin

Given PO

Trial Locations (174)

1145

Starship Children's Hospital, Grafton

2031

Sydney Children's Hospital, Randwick

2145

The Children's Hospital at Westmead, Westmead

2310

John Hunter Children's Hospital, Hunter Regional Mail Centre

3052

Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, South Brisbane

5006

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

6008

Princess Margaret Hospital for Children, Perth

6009

Perth Children's Hospital, Perth

8011

Christchurch Hospital, Christchurch

10029

Mount Sinai Hospital, New York

10032

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

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10595

New York Medical College, Valhalla

11211

King Faisal Specialist Hospital and Research Centre, Riyadh

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

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

24014

Carilion Children's, Roanoke

26506

West Virginia University Healthcare, Morgantown

27157

Wake Forest University Health Sciences, Winston-Salem

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

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

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

33316

Broward Health Medical Center, Fort Lauderdale

33407

Saint Mary's Hospital, West Palm Beach

33606

Tampa General Hospital, Tampa

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

38105

Saint Jude Children's Research Hospital, Memphis

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

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

49007

Bronson Methodist Hospital, Kalamazoo

49503

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

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

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

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

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

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

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

78411

Driscoll Children's Hospital, Corpus Christi

78723

Dell Children's Medical Center of Central Texas, Austin

79415

UMC Cancer Center / UMC Health System, 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

85202

Banner Children's at Desert, Mesa

89102

University Medical Center of Southern Nevada, 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

91010

City of Hope Comprehensive Cancer Center, Duarte

92123

Rady Children's Hospital - San Diego, San Diego

92134

Naval Medical Center -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

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

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

99508

Providence Alaska Medical Center, Anchorage

72202-3591

Arkansas Children's Hospital, Little Rock

06106

Connecticut Children's Medical Center, Hartford

04401

Eastern Maine Medical Center, Bangor

04074

Maine Children's Cancer Program, Scarborough

20889-5600

Walter Reed National Military Medical Center, Bethesda

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

01199

Baystate Medical Center, Springfield

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

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

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

L8N 3Z5

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton

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

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

G1V 4G2

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

00726

HIMA San Pablo Oncologic Hospital, Caguas

00912

San Jorge Children's Hospital, San Juan

00926

University Pediatric Hospital, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK