Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

197

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAdult Acute Myeloid Leukemia in RemissionAdult 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); RUNX1-RUNX1T1Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLLAdult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARAAlkylating Agent-Related Acute Myeloid LeukemiaChronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromePreviously Treated Myelodysplastic SyndromeRecurrent Adult Acute Myeloid LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromeUntreated Adult Acute Myeloid Leukemia
Interventions
DRUG

Azacitidine

Given SC

DRUG

Entinostat

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

Trial Locations (234)

10016

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

10029

Mount Sinai Medical Center, New York

10461

Montefiore Medical Center-Weiler Hospital, The Bronx

10940

Orange Regional Medical Center, Middletown

11030

North Shore University Hospital, Manhasset

11040

Long Island Jewish Medical Center, New Hyde Park

11042

Northwell Health NCORP, Lake Success

12801

Adirondack Cancer Center, Glens Falls

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

16801

Geisinger Medical Group, State College

17403

WellSpan Health-York Hospital, York

17822

Geisinger Medical Center, Danville

18201

Geisinger Medical Center-Cancer Center Hazleton, Hazleton

18501

Mercy Hospital, Scranton

18510

Scranton Hematology Oncology, Scranton

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19010

Bryn Mawr Hospital, Bryn Mawr

19096

Lankenau Medical Center, Wynnewood

Main Line Health NCORP, Wynnewood

19111

Fox Chase Cancer Center, Philadelphia

19301

Paoli Memorial Hospital, Paoli

19718

Christiana Care Health System-Christiana Hospital, Newark

19958

Beebe Medical Center, Lewes

20016

Sibley Memorial Hospital, Washington D.C.

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

21921

Union Hospital of Cecil County, Elkton

24541

Danville Regional Medical Center, Danville

27157

Wake Forest University Health Sciences, Winston-Salem

27858

East Carolina University, Greenville

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28501

Kinston Medical Specialists PA, Kinston

30322

Emory University/Winship Cancer Institute, Atlanta

37920

University of Tennessee - Knoxville, Knoxville

38301

Jackson-Madison County General Hospital, Jackson

44106

Case Western Reserve University, Cleveland

44307

Akron General Medical Center, Akron

46360

Franciscan Saint Anthony Health-Michigan City, Michigan City

46845

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

48202

Henry Ford Hospital, Detroit

50010

McFarland Clinic PC-William R Bliss Cancer Center, Ames

50307

Mercy Capitol, Des Moines

50309

Iowa Methodist Medical Center, Des Moines

Iowa-Wide Oncology Research Coalition NCORP, Des Moines

Medical Oncology and Hematology Associates-Des Moines, Des Moines

50314

Medical Oncology and Hematology Associates-Laurel, Des Moines

Mercy Medical Center - Des Moines, Des Moines

50316

Iowa Lutheran Hospital, Des Moines

50325

Medical Oncology and Hematology Associates-West Des Moines, Clive

51101

Siouxland Regional Cancer Center, Sioux City

51104

Mercy Medical Center-Sioux City, Sioux City

Saint Luke's Regional Medical Center, Sioux City

52242

University of Iowa/Holden Comprehensive Cancer Center, Iowa City

53215

Medical Consultants Limited, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

55455

University of Minnesota/Masonic Cancer Center, Minneapolis

55905

Mayo Clinic, Rochester

56537

Lake Region Healthcare Corporation-Cancer Care, Fergus Falls

56601

Sanford Clinic North-Bemidgi, Bemidji

57104

Sanford Cancer Center-Oncology Clinic, Sioux Falls

57105

Medical X-Ray Center, Sioux Falls

58122

Sanford Clinic North-Fargo, Fargo

Sanford Medical Center-Fargo, Fargo

59101

Billings Clinic Cancer Center, Billings

Montana Cancer Consortium NCORP, Billings

Northern Rockies Radiation Oncology Center, Billings

Saint Vincent Healthcare, Billings

59102

Frontier Cancer Center and Blood Institute-Billings, Billings

59405

Benefis Healthcare- Sletten Cancer Institute, Great Falls

Berdeaux, Donald MD (UIA Investigator), Great Falls

Big Sky Oncology, Great Falls

Great Falls Clinic, Great Falls

59501

Northern Montana Hospital, Havre

59601

Saint Peter's Community Hospital, Helena

59701

Saint James Community Hospital and Cancer Treatment Center, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

Bozeman Deaconess Hospital, Bozeman

59802

Montana Cancer Specialists, Missoula

Saint Patrick Hospital - Community Hospital, Missoula

59804

Community Medical Hospital, Missoula

Guardian Oncology and Center for Wellness, Missoula

59901

Glacier Oncology PLLC, Kalispell

Kalispell Medical Oncology, Kalispell

Kalispell Regional Medical Center, Kalispell

60048

NorthShore Hematology Oncology-Libertyville, Libertyville

60076

Edward H Kaplan MD and Associates, Skokie

Hematology Oncology Associates of Illinois - Skokie, Skokie

60153

Loyola University Medical Center, Maywood

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60402

MacNeal Hospital and Cancer Center, Berwyn

60432

Midwest Center for Hematology Oncology, Joliet

60435

Joliet Oncology-Hematology Associates Limited, Joliet

60504

Rush - Copley Medical Center, Aurora

60563

DuPage Medical Group-Ogden, Naperville

60611

Hematology and Oncology Associates, Chicago

Northwestern University, Chicago

60612

Jesse Brown Veterans Affairs Medical Center, Chicago

John H Stroger Jr Hospital of Cook County, Chicago

University of Illinois, Chicago

60616

Mercy Hospital and Medical Center, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

60640

Weiss Memorial Hospital, Chicago

60657

Presence Saint Joseph Hospital-Chicago, Chicago

60714

Illinois Cancer Specialists-Niles, Niles

61104

Swedish American Hospital, Rockford

61114

SwedishAmerican Regional Cancer Center/ACT, Rockford

61350

Illinois CancerCare-Ottawa Clinic, Ottawa

Ottawa Regional Hospital and Healthcare Center, Ottawa

61354

Illinois CancerCare-Peru, Peru

Illinois Valley Hospital, Peru

61356

Illinois CancerCare-Princeton, Princeton

Perry Memorial Hospital, Princeton

61362

Illinois CancerCare-Spring Valley, Spring Valley

Saint Margaret's Hospital, Spring Valley

61401

Galesburg Cottage Hospital, Galesburg

Illinois CancerCare-Galesburg, Galesburg

61443

Illinois CancerCare-Kewanee Clinic, Kewanee

61455

Illinois CancerCare-Macomb, Macomb

Mcdonough District Hospital, Macomb

61462

Holy Family Medical Center, Monmouth

Illinois CancerCare-Monmouth, Monmouth

61520

Graham Hospital Association, Canton

Illinois CancerCare-Canton, Canton

61530

Eureka Hospital, Eureka

Illinois CancerCare-Eureka, Eureka

61554

Illinois CancerCare-Pekin, Pekin

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin

Pekin Hospital, Pekin

61603

Methodist Medical Center of Illinois, Peoria

61614

Proctor Hospital, Peoria

61615

Illinois CancerCare-Peoria, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61701

Saint Joseph Medical Center, Bloomington

61704

Illinois CancerCare-Bloomington, Bloomington

61747

Hopedale Medical Complex - Hospital, Hopedale

61761

Bromenn Regional Medical Center, Normal

Community Cancer Center Foundation, Normal

Illinois CancerCare-Community Cancer Center, Normal

61801

Carle Clinic-Urbana Main, Urbana

62321

Illinois CancerCare-Carthage, Carthage

Memorial Hospital, Carthage

62526

Decatur Memorial Hospital, Decatur

Heartland Cancer Research NCORP, Decatur

62644

Illinois CancerCare-Havana, Havana

Mason District Hospital, Havana

62781

Memorial Medical Center, Springfield

63110

Saint Louis University Hospital, St Louis

63701

Southeast Missouri Hospital, Cape Girardeau

64057

Centerpoint Medical Center LLC, Independence

64068

Liberty Hospital, Liberty

Liberty Radiation Oncology Center, Liberty

64086

Saint Luke's East - Lee's Summit, Lee's Summit

64108

Truman Medical Center, Kansas City

64111

Saint Luke's Cancer Institute, Kansas City

Saint Luke's Hospital of Kansas City, Kansas City

64114

Radiation Oncology Practice Corporation South, Kansas City

Saint Joseph Health Center, Kansas City

64116

North Kansas City Hospital, Kansas City

64118

Heartland Hematology and Oncology Associates Incorporated, Kansas City

64132

Research Medical Center, Kansas City

64154

Radiation Oncology Practice Corporation - North, Kansas City

64506

Heartland Regional Medical Center, Saint Joseph

64507

Saint Joseph Oncology Inc, Saint Joseph

65201

Veterans Administration, Columbia

65212

University of Missouri - Ellis Fischel, Columbia

66044

Lawrence Memorial Hospital, Lawrence

66112

Providence Medical Center, Kansas City

66204

Shawnee Mission Medical Center-KCCC, Shawnee Mission

66208

Kansas City NCI Community Oncology Research Program, Prairie Village

66209

Menorah Medical Center, Overland Park

66210

Radiation Oncology Practice Corporation Southwest, Overland Park

66213

Saint Luke's South Hospital, Overland Park

66606

Saint Francis Hospital and Medical Center - Topeka, Topeka

66701

Cancer Center of Kansas - Fort Scott, Fort Scott

66720

Cancer Center of Kansas - Chanute, Chanute

67003

Hospital District Sixth of Harper County, Anthony

67042

Cancer Center of Kansas - El Dorado, El Dorado

67068

Cancer Center of Kansas-Kingman, Kingman

67114

Cancer Center of Kansas - Newton, Newton

67124

Cancer Center of Kansas - Pratt, Pratt

67152

Cancer Center of Kansas - Wellington, Wellington

67156

Cancer Center of Kansas - Winfield, Winfield

67208

Associates In Womens Health, Wichita

Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita

67214

Cancer Center of Kansas - Wichita, Wichita

Via Christi Regional Medical Center, Wichita

Wichita NCI Community Oncology Research Program, Wichita

67301

Cancer Center of Kansas-Independence, Independence

67357

Cancer Center of Kansas - Parsons, Parsons

67401

Cancer Center of Kansas - Salina, Salina

Salina Regional Health Center, Salina

67801

Cancer Center of Kansas - Dodge City, Dodge City

67905

Cancer Center of Kansas-Liberal, Liberal

75235

Zale Lipshy University Hospital, Dallas

75390

Clements University Hospital, Dallas

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

76508

Scott and White Memorial Hospital, Temple

80012

The Medical Center of Aurora, Aurora

80033

SCL Health Lutheran Medical Center, Wheat Ridge

80113

Swedish Medical Center, Englewood

80124

Sky Ridge Medical Center, Lone Tree

80210

Porter Adventist Hospital, Denver

80218

Presbyterian - Saint Lukes Medical Center - Health One, Denver

SCL Health Saint Joseph Hospital, Denver

80220

Rose Medical Center, Denver

80222

Colorado Cancer Research Program NCORP, Denver

80228

Saint Anthony Hospital, Lakewood

80229

North Suburban Medical Center, Thornton

80301

Boulder Community Hospital, Boulder

80501

Longmont United Hospital, Longmont

80524

Poudre Valley Hospital, Fort Collins

80528

Front Range Cancer Specialists, Fort Collins

80539

McKee Medical Center, Loveland

80631

North Colorado Medical Center, Greeley

80907

Penrose-Saint Francis Healthcare, Colorado Springs

81004

Saint Mary Corwin Medical Center, Pueblo

81502

Saint Mary's Hospital and Regional Medical Center, Grand Junction

82609

Rocky Mountain Oncology, Casper

82801

Welch Cancer Center, Sheridan

84107

Cottonwood Hospital Medical Center, Murray

85259

Mayo Clinic in Arizona, Scottsdale

87110

Presbyterian Kaseman Hospital, Albuquerque

90057

Los Angeles Oncology Institute, Los Angeles

91505

Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank

94304

Stanford Cancer Institute, Palo Alto

95661

Sutter Roseville Medical Center, Roseville

95816

Sutter General Hospital, Sacramento

04401

Eastern Maine Medical Center, Bangor

02118

Boston Medical Center, Boston

08724

Ocean Medical Center, Brick

08103

Cooper Hospital University Medical Center, Camden

10467-2490

Montefiore Medical Center - Moses Campus, The Bronx

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00313586 - Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter