Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

546

Participants

Timeline

Start Date

November 15, 2006

Primary Completion Date

January 31, 2011

Study Completion Date

December 1, 2016

Conditions
Acute Myeloid LeukemiaAcute Myeloid Leukemia With Myelodysplasia-Related ChangesAdult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2AUntreated Adult Acute Myeloid Leukemia
Interventions
PROCEDURE

Autologous Bone Marrow Transplantation

Undergo autologous bone marrow transplantation

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSC transplantation

DRUG

Busulfan

Given IV

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Decitabine

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Trial Locations (46)

10029

Mount Sinai Hospital, New York

11030

North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11042

Northwell Health NCORP, Lake Success

Northwell Health/Center for Advanced Medicine, Lake Success

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

15224

West Penn Hospital, Pittsburgh

19718

Christiana Care Health System-Christiana Hospital, Newark

19958

Beebe Medical Center, Lewes

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21921

Union Hospital of Cecil County, Elkton

27157

Wake Forest University Health Sciences, Winston-Salem

27534

Wayne Memorial Hospital, Goldsboro

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

30342

Blood and Marrow Transplant Group of Georgia, Atlanta

32803

Florida Hospital Orlando, Orlando

43210

Ohio State University Comprehensive Cancer Center, Columbus

46845

Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60612

University of Illinois, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

63110

Washington University School of Medicine, St Louis

65201

Veterans Administration, Columbia

65212

University of Missouri - Ellis Fischel, Columbia

68198

University of Nebraska Medical Center, Omaha

69101

Great Plains Health Callahan Cancer Center, North Platte

73104

University of Oklahoma Health Sciences Center, Oklahoma City

89102

University Medical Center of Southern Nevada, Las Vegas

89106

Nevada Cancer Research Foundation CCOP, Las Vegas

89109

Sunrise Hospital and Medical Center, Las Vegas

94115

UCSF Medical Center-Mount Zion, San Francisco

04401

Eastern Maine Medical Center, Bangor

20889-5600

Walter Reed National Military Medical Center, Bethesda

02114

Massachusetts General Hospital Cancer Center, Boston

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

01605

Commonwealth Hematology Oncology PC-Worcester, Worcester

03431

Cheshire Medical Center-Dartmouth-Hitchcock Keene, Keene

03756

Dartmouth Hitchcock Medical Center, Lebanon

08103

Cooper Hospital University Medical Center, Camden

02903

Rhode Island Hospital, Providence

02906

Miriam Hospital, Providence

05602

Central Vermont Medical Center/National Life Cancer Treatment, Berlin Corners

05405

University of Vermont College of Medicine, Burlington

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00416598 - Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter