ClinicalTrials.gov record
Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT00313586
Public ClinicalTrials.gov record NCT00313586. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00313586
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 197 participants
Conditions and interventions
Conditions
- 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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2006 (Type not available)
- Primary completion
- Jul 2013 (Actual)
- Completion
- Jul 2013 (Actual)
- Last update posted
- Feb 2, 2017
2006 – 2013
United States locations
- U.S. sites
- 234
- U.S. states
- 31
- U.S. cities
- 149
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | — |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | — |
| Los Angeles Oncology Institute | Los Angeles | California | 90057 | — |
| Stanford Cancer Institute | Palo Alto | California | 94304 | — |
| Sutter Roseville Medical Center | Roseville | California | 95661 | — |
| Sutter General Hospital | Sacramento | California | 95816 | — |
| The Medical Center of Aurora | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301 | — |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| SCL Health Saint Joseph Hospital | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| Colorado Cancer Research Program NCORP | Denver | Colorado | 80222 | — |
| Swedish Medical Center | Englewood | Colorado | 80113 | — |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | — |
| Front Range Cancer Specialists | Fort Collins | Colorado | 80528 | — |
| Saint Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | — |
| MacNeal Hospital and Cancer Center | Berwyn | Illinois | 60402 | — |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | — |
| Graham Hospital Association | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Jesse Brown Veterans Affairs Medical Center | Chicago | Illinois | 60612 | — |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Mercy Hospital and Medical Center | Chicago | Illinois | 60616 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | — |
| Presence Saint Joseph Hospital-Chicago | Chicago | Illinois | 60657 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Heartland Cancer Research NCORP | Decatur | Illinois | 62526 | — |
| Eureka Hospital | Eureka | Illinois | 61530 | — |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare-Havana | Havana | Illinois | 62644 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Hopedale Medical Complex - Hospital | Hopedale | Illinois | 61747 | — |
| Midwest Center for Hematology Oncology | Joliet | Illinois | 60432 | — |
| Joliet Oncology-Hematology Associates Limited | Joliet | Illinois | 60435 | — |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| NorthShore Hematology Oncology-Libertyville | Libertyville | Illinois | 60048 | — |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | — |
| Mcdonough District Hospital | Macomb | Illinois | 61455 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Holy Family Medical Center | Monmouth | Illinois | 61462 | — |
| Illinois CancerCare-Monmouth | Monmouth | Illinois | 61462 | — |
| DuPage Medical Group-Ogden | Naperville | Illinois | 60563 | — |
| Illinois Cancer Specialists-Niles | Niles | Illinois | 60714 | — |
| Bromenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Community Cancer Center Foundation | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Community Cancer Center | Normal | Illinois | 61761 | — |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | — |
| Ottawa Regional Hospital and Healthcare Center | Ottawa | Illinois | 61350 | — |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | — |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | — |
| Pekin Hospital | Pekin | Illinois | 61554 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | — |
| Proctor Hospital | Peoria | Illinois | 61614 | — |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | — |
| Illinois Valley Hospital | Peru | Illinois | 61354 | — |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| Swedish American Hospital | Rockford | Illinois | 61104 | — |
| SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | 61114 | — |
| Edward H Kaplan MD and Associates | Skokie | Illinois | 60076 | — |
| Hematology Oncology Associates of Illinois - Skokie | Skokie | Illinois | 60076 | — |
| Illinois CancerCare-Spring Valley | Spring Valley | Illinois | 61362 | — |
| Saint Margaret's Hospital | Spring Valley | Illinois | 61362 | — |
| Memorial Medical Center | Springfield | Illinois | 62781 | — |
| Carle Clinic-Urbana Main | Urbana | Illinois | 61801 | — |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana | 46845 | — |
| Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana | 46360 | — |
| McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa | 50010 | — |
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | — |
| Mercy Capitol | Des Moines | Iowa | 50307 | — |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | — |
| Iowa-Wide Oncology Research Coalition NCORP | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | — |
| Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | 50314 | — |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | — |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| Siouxland Regional Cancer Center | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | — |
| Saint Luke's Regional Medical Center | Sioux City | Iowa | 51104 | — |
| Hospital District Sixth of Harper County | Anthony | Kansas | 67003 | — |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | — |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | — |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | — |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | — |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | — |
| Providence Medical Center | Kansas City | Kansas | 66112 | — |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | — |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | — |
| Menorah Medical Center | Overland Park | Kansas | 66209 | — |
| Radiation Oncology Practice Corporation Southwest | Overland Park | Kansas | 66210 | — |
| Saint Luke's South Hospital | Overland Park | Kansas | 66213 | — |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | — |
| Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas | 66208 | — |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | — |
| Salina Regional Health Center | Salina | Kansas | 67401 | — |
| Shawnee Mission Medical Center-KCCC | Shawnee Mission | Kansas | 66204 | — |
| Saint Francis Hospital and Medical Center - Topeka | Topeka | Kansas | 66606 | — |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | — |
| Associates In Womens Health | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | — |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | — |
| Wichita NCI Community Oncology Research Program | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sanford Clinic North-Bemidgi | Bemidji | Minnesota | 56601 | — |
| Lake Region Healthcare Corporation-Cancer Care | Fergus Falls | Minnesota | 56537 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Southeast Missouri Hospital | Cape Girardeau | Missouri | 63701 | — |
| Veterans Administration | Columbia | Missouri | 65201 | — |
| University of Missouri - Ellis Fischel | Columbia | Missouri | 65212 | — |
| Centerpoint Medical Center LLC | Independence | Missouri | 64057 | — |
| Truman Medical Center | Kansas City | Missouri | 64108 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Radiation Oncology Practice Corporation South | Kansas City | Missouri | 64114 | — |
| Saint Joseph Health Center | Kansas City | Missouri | 64114 | — |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | — |
| Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri | 64118 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Radiation Oncology Practice Corporation - North | Kansas City | Missouri | 64154 | — |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | — |
| Liberty Hospital | Liberty | Missouri | 64068 | — |
| Liberty Radiation Oncology Center | Liberty | Missouri | 64068 | — |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | — |
| Saint Joseph Oncology Inc | Saint Joseph | Missouri | 64507 | — |
| Saint Louis University Hospital | St Louis | Missouri | 63110 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| Montana Cancer Consortium NCORP | Billings | Montana | 59101 | — |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | — |
| Saint Vincent Healthcare | Billings | Montana | 59101 | — |
| Frontier Cancer Center and Blood Institute-Billings | Billings | Montana | 59102 | — |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | — |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | — |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana | 59405 | — |
| Big Sky Oncology | Great Falls | Montana | 59405 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Northern Montana Hospital | Havre | Montana | 59501 | — |
| Saint Peter's Community Hospital | Helena | Montana | 59601 | — |
| Glacier Oncology PLLC | Kalispell | Montana | 59901 | — |
| Kalispell Medical Oncology | Kalispell | Montana | 59901 | — |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | — |
| Montana Cancer Specialists | Missoula | Montana | 59802 | — |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | — |
| Community Medical Hospital | Missoula | Montana | 59804 | — |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | — |
| Ocean Medical Center | Brick | New Jersey | 08724 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | 87110 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Adirondack Cancer Center | Glens Falls | New York | 12801 | — |
| Northwell Health NCORP | Lake Success | New York | 11042 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Orange Regional Medical Center | Middletown | New York | 10940 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Montefiore Medical Center-Weiler Hospital | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467-2490 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| East Carolina University | Greenville | North Carolina | 27858 | — |
| Kinston Medical Specialists PA | Kinston | North Carolina | 28501 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Clinic North-Fargo | Fargo | North Dakota | 58122 | — |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | — |
| Akron General Medical Center | Akron | Ohio | 44307 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | 18201 | — |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | — |
| Mercy Hospital | Scranton | Pennsylvania | 18501 | — |
| Scranton Hematology Oncology | Scranton | Pennsylvania | 18510 | — |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | — |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Main Line Health NCORP | Wynnewood | Pennsylvania | 19096 | — |
| WellSpan Health-York Hospital | York | Pennsylvania | 17403 | — |
| Sanford Cancer Center-Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Medical X-Ray Center | Sioux Falls | South Dakota | 57105 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | — |
| University of Tennessee - Knoxville | Knoxville | Tennessee | 37920 | — |
| Zale Lipshy University Hospital | Dallas | Texas | 75235 | — |
| Clements University Hospital | Dallas | Texas | 75390 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | — |
| Danville Regional Medical Center | Danville | Virginia | 24541 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | — |
| Medical Consultants Limited | Milwaukee | Wisconsin | 53215 | — |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | — |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00313586, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00313586 live on ClinicalTrials.gov.