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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00313586
First received: April 11, 2006
Last updated: March 16, 2016
Last verified: January 2016
  Purpose
This randomized phase II trial studies azacitidine with or without entinostat to see how well they work compared to azacitidine alone in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may work better in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.

Condition Intervention Phase
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
Alkylating Agent-Related Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Drug: Azacitidine
Drug: Entinostat
Other: Laboratory Biomarker Analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor Entinostat for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia With Multilineage Dysplasia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of Patients With Clinical Response [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry. ] [ Designated as safety issue: No ]

    Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria:

    1. World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett)
    2. Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.)
    3. Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)


Enrollment: 197
Study Start Date: August 2006
Estimated Study Completion Date: April 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (azacitidine)
Patients receive azacitidine SC QD on days 1-10. Treatment repeats every 28 days for 6-24 courses in the absence of disease progression or unacceptable toxicity.
Drug: Azacitidine
Given SC
Other Names:
  • 5 AZC
  • 5-AC
  • 5-Azacytidine
  • 5-AZC
  • Azacytidine
  • Azacytidine, 5-
  • Ladakamycin
  • Mylosar
  • U-18496
  • Vidaza
Other: Laboratory Biomarker Analysis
Correlative studies
Experimental: Arm B (azacitidine, entinostat)
Patients receive azacitidine as in Arm A and entinostat PO on days 3 and 10. Treatment repeats every 28 days for 6-24 courses in the absence of disease progression or unacceptable toxicity.
Drug: Azacitidine
Given SC
Other Names:
  • 5 AZC
  • 5-AC
  • 5-Azacytidine
  • 5-AZC
  • Azacytidine
  • Azacytidine, 5-
  • Ladakamycin
  • Mylosar
  • U-18496
  • Vidaza
Drug: Entinostat
Given PO
Other Names:
  • HDAC inhibitor SNDX-275
  • MS 27-275
  • MS-275
  • SNDX-275
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the overall response rate (complete, partial, and hematologic improvement-major by International Working Group [IWG] criteria) in response to azacitidine and entinostat.

II. To estimate the major response rate (complete and partial responses by the IWG response criteria) to a 10-day regimen of azacitidine and to the same regimen of azacitidine in combination with entinostat administered orally on days 3 and 10 of each cycle in patients with de novo myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMMoL) (dysplastic) and acute myeloid leukemia with trilineage dysplasia (AML-TLD), as well as in patients with treatment-induced MDS, CMMoL (dysplastic) and AML-TLD.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of azacitidine and entinostat in this patient population.

II. To identify changes in gene promoter methylation and gene expression which may be associated with response to azacitidine and entinostat.

III. To identify other molecular mechanisms (such as deoxyribonucleic acid [DNA] damage) which may be associated with response to azacitidine and entinostat.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive azacitidine subcutaneously (SC) once daily (QD) on days 1-10.

ARM B: Patients receive azacitidine as in Arm A and entinostat orally (PO) on days 3 and 10.

In both arms, treatment repeats every 28 days for 6-24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The following diagnoses will be eligible for this study:
  • Myelodysplastic syndromes: the diagnosis of MDS must be confirmed by a bone marrow aspirate and/or biopsy within two weeks prior to registration; NOTE: blast count must be < 20%; patients with any International Prognostic Score (IPSS) are eligible; patients with low or intermediate (INT)-1 IPSS must have a platelet count < 50,000/mm^3 and/or absolute neutrophil count (ANC) < 500/mm^3 within seven days prior to registration
  • Chronic myelomonocytic leukemia (dysplastic subtype): the diagnosis of CMMoL must be confirmed by a bone marrow aspirate and/or biopsy within two weeks prior to registration; patients with CMMoL must have a WBC < 12,000/mm^3, documented within 4 weeks prior to study entry (two sets of counts that are 2 weeks apart will be taken)
  • Acute myeloid leukemia with multilineage dysplasia: the diagnosis of AML-TLD must be confirmed by a bone marrow aspirate and/or biopsy within two weeks prior to registration; NOTE: there must be evidence of >= 20% blasts on the review of the bone marrow aspirate and/or biopsy; AML-TLD will be interpreted to include patients formerly diagnosed by French-American-British (FAB) criteria as refractory anemia with excess blasts in transformation (RAEB-t), as well as patients with no history of antecedent hematologic disorder who have AML which meets criteria for AML-TLD by World Health Organization (WHO) criteria; patients with AML-TLD must have a white blood cell (WBC) =< 30,000/mm^3 documented within 4 weeks prior to study entry (two sets of counts that are 2 weeks apart will be taken); patients whose WBC has doubled within this period of time and is greater than 20,000/mm^3 at the time of screening will not be eligible
  • Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
  • Patient must have no prior treatment with azacitidine, decitabine or entinostat
  • Patients must not have active infections at the time of registration
  • Serum creatinine < 2.0 mg/dL; test must be done within seven days prior to registration
  • Total serum bilirubin within institutional limits unless due to intra- or extramedullary hemolysis or Gilbert's syndrome; test must be done within seven days prior to registration
  • Aspartate transaminase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN); tests must be done within seven days prior to registration
  • Patients must not have received any AML induction chemotherapy or stem cell transplantation; any other treatment for their disease, including hematopoietic growth factors may not be given, within three weeks prior to registration, and should have recovered from all toxicities of prior therapy (to grade 0 or 1)
  • Patients must have no clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia
  • Patients must have no serious or uncontrolled medical conditions
  • Patients who have therapy-induced MDS, CMMoL (dysplastic) and AML-TLD are eligible and will be treated as separate cohorts from the patients with de novo MDS, CMMoL (dysplastic) and AML-TLD
  • Patients should have a life expectancy of at least six months
  • Patients must not have advanced malignant hepatic tumors
  • Patients must not have a known hypersensitivity to azacitidine or mannitol
  • Southwest Oncology Group (SWOG) ONLY: all SWOG patients must be registered on SWOG-9007 ("Cytogenetic Studies in Leukemia Patients"); collection of the pretreatment bone marrow specimen (or of peripheral blood if the marrow is not aspirable) must be completed within 28 days before registration; the pretreatment specimen must be submitted to a SWOG-approved cytogenetics laboratory as described in protocol SWOG-9007; note that submission of bone marrow cytogenetic studies are required to calculate the IPSS score (stratification issue); in addition, cytogenetic response will be measured at follow-up requiring a second cytogenetic study at the end of protocol treatment; NOTE: In addition to SWOG-9007, SWOG patients must be offered participation in S9910, the leukemia centralized reference laboratories and tissue repositories ancillary study; If consent is given, collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. If the patient consents to participate in S9910, pretreatment specimens of marrow and/or peripheral blood must be submitted to the Southwest Oncology Group Myeloid Repository at the University of New Mexico for cellular and molecular studies; S9910 also requests submission of remission and relapse specimens
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313586

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Los Angeles Oncology Institute
Los Angeles, California, United States, 90057
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP
Denver, Colorado, United States, 80222
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
MacNeal Hospital and Cancer Center
Berwyn, Illinois, United States, 60402
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Northwestern University
Chicago, Illinois, United States, 60611
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States, 60612
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
University of Illinois
Chicago, Illinois, United States, 60612
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Saint Joseph Hospital
Chicago, Illinois, United States, 60657
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
DuPage Medical Group-Ogden
Naperville, Illinois, United States, 60563
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61114
Edward H Kaplan MD and Associates
Skokie, Illinois, United States, 60076
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Capitol
Des Moines, Iowa, United States, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Providence Medical Center
Kansas City, Kansas, United States, 66112
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, United States, 66210
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City NCI Community Oncology Research Program
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, United States, 66204
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States, 56537
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Veterans Administration
Columbia, Missouri, United States, 65201
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Radiation Oncology Practice Corporation South
Kansas City, Missouri, United States, 64114
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, United States, 64154
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Liberty Radiation Oncology Center
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Montana
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States, 59102
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Community Medical Hospital
Missoula, Montana, United States, 59801
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, New Jersey
Ocean Medical Center
Brick, New Jersey, United States, 08724
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New Mexico
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
United States, New York
Montefiore Medical Center-Weiler Hospital
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Adirondack Cancer Center
Glens Falls, New York, United States, 12801
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System NCORP
Manhasset, New York, United States, 11030
Orange Regional Medical Center
Middletown, New York, United States, 10940
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
East Carolina University
Greenville, North Carolina, United States, 27858
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Mercy Hospital
Scranton, Pennsylvania, United States, 18501
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Main Line Health NCORP
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
Clements University Hospital
Dallas, Texas, United States, 75390
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Medical Consultants Limited
Milwaukee, Wisconsin, United States, 53215
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Gore ECOG-ACRIN Cancer Research Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00313586     History of Changes
Other Study ID Numbers: NCI-2009-01077  NCI-2009-01077  ECOG-E1905  CDR0000466186  E1905  E1905  U10CA180820  U10CA021115 
Study First Received: April 11, 2006
Results First Received: November 18, 2014
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Syndrome
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Neoplasm Metastasis
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplastic Processes
Myelodysplastic-Myeloproliferative Diseases
Azacitidine
Entinostat
Histone Deacetylase Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016