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: October 25, 2013
Last verified: October 2013
  Purpose

This randomized phase II trial is studying azacitidine and 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 or by stopping them from dividing. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may kill more cancer cells.


Condition Intervention Phase
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Untreated Adult Acute Myeloid Leukemia
Drug: entinostat
Drug: azacitidine
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:
  • The complete response rate, partial response rate, and trilineage response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Graded according to standard international response criteria.


Secondary Outcome Measures:
  • Overall response rate (complete response and partial response) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Graded according to standard international response criteria. Summarized by treatment arm in each cohort.

  • Rate of grade 3 or 4 non-hematologic toxicity thought to be possibly or likely related to study drugs, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Summarized by treatment arm in each cohort.

  • Percentage of patients treated and become appropriate candidates for allogeneic transplant [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Summarized by treatment arm in each cohort.


Estimated Enrollment: 196
Study Start Date: August 2006
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive azacitidine subcutaneously once daily on days 1-10.
Drug: azacitidine
Given subcutaneously
Other Names:
  • 5-AC
  • 5-azacytidine
  • azacytidine
  • Vidaza
Experimental: Arm II
Patients receive azacitidine as in arm I and oral entinostat on days 3 and 10.
Drug: entinostat
Given orally
Other Names:
  • HDAC inhibitor SNDX-275
  • SNDX-275
Drug: azacitidine
Given subcutaneously
Other Names:
  • 5-AC
  • 5-azacytidine
  • azacytidine
  • Vidaza

Detailed Description:

PRIMARY OBJECTIVES:

I. Compare the overall response rate (complete, partial, and hematologic improvement-major by International Working Group [IWG] criteria) in patients with treatment-induced or non-treatment-induced myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (dysplastic), or acute myeloid leukemia with multilineage dysplasia treated with azacitidine with vs without entinostat.

II. Compare the major response rate (complete and partial responses by IWG criteria) in patients treated with these regimens.

SECONDARY OBJECTIVES:

I. Evaluate the toxicity of azacitidine and entinostatin these patients. II. Identify changes in gene promoter methylation and gene expression that may be associated with response to azacitidine and entinostat.

III. Identify other molecular mechanisms (such as DNA damage) that may be associated with response to azacitidine and entinostat.

OUTLINE: This is a randomized, multicenter study. Patients are first stratified according to treatment-related disease (yes vs no), followed by a second stratification according to disease (myelodysplastic syndromes [MDS] high/intermediate-2 vs MDS low/intermediate-1 vs chronic myelomonocytic leukemia vs acute myeloid leukemia with multilineage dysplasia). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive azacitidine subcutaneously once daily on days 1-10.

ARM II: Patients receive azacitidine as in arm I and oral entinostat on days 3 and 10.

Treatment in both arms repeats every 28 days for at least 6 and up to 24 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bone marrow aspirate and/or biopsy-confirmed diagnosis of 1 of the following:

    • Myelodysplastic syndromes (MDS)

      • Any International Prognostic Score (IPSS) eligible

        • Patients with low or intermediate-1 IPSS must have platelet count < 50,000/mm³ and/or absolute neutrophil count < 500/mm³
      • Blast count < 20%
    • Chronic myelomonocytic leukemia (dysplastic subtype)

      • WBC < 12,000/mm³ (measured twice within the past 4 weeks, 2 weeks apart)
    • Acute myeloid leukemia with multilineage dysplasia (AML-TLD)

      • Formerly diagnosed refractory anemia with excess blasts in transformation by FAB criteria allowed
      • AML-TLD by WHO criteria allowed in patients with no history of antecedent hematologic disorder
      • WBC ≤ 30,000/mm³ (measured twice within the past 4 weeks, 2 weeks apart)

        • WBC that has doubled over 4 weeks AND > 20,000/mm³ is not eligible
      • Evidence of ≥ 20% blasts on review of the bone marrow aspirate and/or biopsy
  • SWOG patients must be enrolled in research study trial SWOG-9007
  • Therapy-induced MDS, AML-TLD, or chronic myelomonocytic leukemia (dysplastic subtype) allowed
  • No clinical evidence of CNS or pulmonary leukostasis or disseminated intravascular coagulation
  • No clinical evidence of CNS leukemia
  • No filgrastim (G-CSF) or pegfilgrastim during days 1-10 of each treatment course
  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Creatinine < 2.0 mg/dL
  • Bilirubin normal (unless due to intramedullary or extramedullary hemolysis, or Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infections
  • No advanced malignant hepatic tumors
  • No other serious or uncontrolled medical conditions
  • No known hypersensitivity to azacitidine or mannitol
  • Recovered from prior therapy
  • No prior azacitidine, decitabine or entinostat
  • No prior induction chemotherapy for AML or stem cell transplantation
  • No hematopoietic growth factors within 3 weeks prior to study entry
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No concurrent valproic acid, epoetin alfa, or darbepoetin alfa
  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
Burbank, California, United States, 91505
Los Angeles Oncology Institute
Los Angeles, California, United States, 90057
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
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
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80110
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
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
Exempla 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
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Hematology Oncology Associates-Berwyn
Berwyn, Illinois, United States, 60402
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
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
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Illinois
Chicago, Illinois, United States, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, United States, 60612
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
Northwestern University
Chicago, Illinois, United States, 60611
Saint Joseph Hospital
Chicago, Illinois, United States, 60657
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
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
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare-Macomb
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
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Pekin Hospital
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61603
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
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
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Swedish American Hospital
Rockford, Illinois, United States, 61104
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Edward H Kaplan MD and Associates
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, 62781-0001
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, United States, 46845
Saint Anthony Memorial Health Center
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
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
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Radiation Oncology Practice Corporation Southwest
Overland Park, Kansas, United States, 66210
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
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
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
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Wichita CCOP
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, 21201-1595
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936
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 Medical Center-Fairview
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, 65203
Centerpoint Medical Center LLC
Independence, Missouri, United States, 64057
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Radiation Oncology Practice Corporation South
Kansas City, Missouri, United States, 64114
Research Medical Center
Kansas City, Missouri, United States, 64132
Radiation Oncology Practice Corporation - North
Kansas City, Missouri, United States, 64154
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Liberty Hospital
Liberty, Missouri, United States, 64068
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, Montana
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
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
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59801
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
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
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Montefiore Medical Center
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-LIJ Health System CCOP
Manhasset, New York, United States, 11030
North Shore University Hospital
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
New York University Langone Medical Center
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
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, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Mercy Hospital
Scranton, Pennsylvania, United States, 18501
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Mainline Health CCOP
Wynnewood, Pennsylvania, United States, 19096
York Hospital
York, Pennsylvania, United States, 17405
United States, South Dakota
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
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
Saint Paul Hospital
Dallas, Texas, United States, 75390
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
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
Investigators
Principal Investigator: Steven Gore Eastern Cooperative Oncology Group
  More Information

No publications provided

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, U10CA021115
Study First Received: April 11, 2006
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Histone Deacetylase Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014