Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

May 2, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

June 30, 2023

Conditions
Acute Myeloid Leukemia Post Cytotoxic TherapyRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia
Interventions
DRUG

Cytarabine

Given IT or IV

BIOLOGICAL

Filgrastim

Given SC or IV

DRUG

Fludarabine Phosphate

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

OTHER

Pharmacological Study

Correlative studies

Trial Locations (73)

10016

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

10032

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

11501

NYU Winthrop Hospital, Mineola

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

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

20010

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

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23507

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

28801

Mission Hospital, Asheville

30322

Children's Healthcare of Atlanta - Egleston, Atlanta

32207

Nemours Children's Clinic-Jacksonville, Jacksonville

32504

Nemours Children's Clinic - Pensacola, Pensacola

32610

University of Florida Health Science Center - Gainesville, Gainesville

33701

Johns Hopkins All Children's Hospital, St. Petersburg

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

38105

Saint Jude Children's Research Hospital, Memphis

39216

University of Mississippi Medical Center, Jackson

40536

University of Kentucky/Markey Cancer Center, Lexington

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Childrens Hospital, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

46260

Ascension Saint Vincent Indianapolis Hospital, Indianapolis

48109

C S Mott Children's Hospital, Ann Arbor

48236

Ascension Saint John Hospital, Detroit

53226

Children's Hospital of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center, Madison

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

Mayo Clinic in Rochester, Rochester

60611

Lurie Children's Hospital-Chicago, Chicago

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital Saint Louis, St Louis

64108

Children's Mercy Hospitals and Clinics, Kansas City

68114

Children's Hospital and Medical Center of Omaha, Omaha

68198

University of Nebraska Medical Center, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

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

78207

Children's Hospital of San Antonio, San Antonio

80045

Children's Hospital Colorado, Aurora

84113

Primary Children's Hospital, Salt Lake City

85016

Phoenix Childrens Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

90242

Kaiser Permanente Downey Medical Center, Downey

91010

City of Hope Comprehensive Cancer Center, Duarte

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

94609

UCSF Benioff Children's Hospital Oakland, Oakland

95817

University of California Davis Comprehensive Cancer Center, Sacramento

97239

Oregon Health and Science University, Portland

98105

Seattle Children's Hospital, Seattle

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

04401

Eastern Maine Medical Center, Bangor

04074

Maine Children's Cancer Program, Scarborough

02114

Massachusetts General Hospital Cancer Center, Boston

02215

Dana-Farber Cancer Institute, Boston

05405

University of Vermont and State Agricultural College, Burlington

R3E 0V9

CancerCare Manitoba, Winnipeg

B3K 6R8

IWK Health Centre, Halifax

K7L 2V7

Kingston Health Sciences Centre, Kingston

H3H 1P3

The Montreal Children's Hospital of the MUHC, Montreal

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

G1V 4G2

Centre Hospitalier Universitaire de Quebec, Québec

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Children's Oncology Group

NETWORK

NCT02642965 - Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter