AzTrials
AzTrials

Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 2NCT00313586

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

A Phase 2 study testing Azacitidine, Entinostat and Laboratory Biomarker Analysis in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Adult Acute Myeloid Leukemia in Remission, run by National Cancer Institute (NCI) at 234 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Azacitidine, Entinostat and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
234 sitesUnited States
Study dates
Aug 2006to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

234 sites in 1 country.

234 sites in 1 country

United States234 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • MacNeal Hospital and Cancer Center

    Berwyn, Illinois, 60402

  • 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

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • 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

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Veterans Administration

    Columbia, Missouri, 65201

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • 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

  • 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

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Adirondack Cancer Center

    Glens Falls, New York, 12801

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • 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

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • East Carolina University

    Greenville, North Carolina, 27858

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Centerpoint Medical Center LLC

    Independence, Missouri, 64057

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Midwest Center for Hematology Oncology

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Providence Medical Center

    Kansas City, Kansas, 66112

  • 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

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Northwell Health NCORP

    Lake Success, New York, 11042

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Liberty Radiation Oncology Center

    Liberty, Missouri, 64068

  • NorthShore Hematology Oncology-Libertyville

    Libertyville, Illinois, 60048

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Los Angeles Oncology Institute

    Los Angeles, California, 90057

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Orange Regional Medical Center

    Middletown, New York, 10940

  • Medical Consultants Limited

    Milwaukee, Wisconsin, 53215

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • 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

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • DuPage Medical Group-Ogden

    Naperville, Illinois, 60563

  • 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

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • 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

  • 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

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • 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

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Swedish American Hospital

    Rockford, Illinois, 61104

  • SwedishAmerican Regional Cancer Center/ACT

    Rockford, Illinois, 61114

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Sutter General Hospital

    Sacramento, California, 95816

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Mercy Hospital

    Scranton, Pennsylvania, 18501

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • 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

  • 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

  • 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

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Saint Francis Hospital and Medical Center - Topeka

    Topeka, Kansas, 66606

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • SCL Health Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • 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

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Main Line Health NCORP

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17403

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Azacitidine, Entinostat, Laboratory Biomarker Analysis
Medical subject headings
Leukemia, Myelomonocytic, Acute, Leukemia, Promyelocytic, Acute, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC

    Given SC

  • EntinostatDrug

    Also called HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00313586
Study groupRoleWhat they receive
Arm A (azacitidine)ExperimentalPatients 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.
Receives: Drug: Azacitidine; Other: Laboratory Biomarker Analysis
Arm B (azacitidine, entinostat)ExperimentalPatients 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.
Receives: Drug: Azacitidine; Drug: Entinostat; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients With Clinical Response

    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.)

    Measured: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2 - 5 years from study entry.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00313586
Sponsor's protocol ID
NCI-2009-01077
Other IDs
NCI-2009-01077, ECOG-E1905, CDR0000466186, E1905, E1905, U10CA180820, U10CA021115
Status last verified
Dec 2016
First submitted
11 Apr 2006
Last updated
2 Feb 2017
Data monitoring committee
Yes

Publications

  • Prebet T, Sun Z, Ketterling RP, Zeidan A, Greenberg P, Herman J, Juckett M, Smith MR, Malick L, Paietta E, Czader M, Figueroa M, Gabrilove J, Erba HP, Tallman MS, Litzow M, Gore SD; Eastern Cooperative Oncology Group and North American Leukemia intergroup. Azacitidine with or without Entinostat for the treatment of therapy-related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study. Br J Haematol. 2016 Feb;172(3):384-91. doi: 10.1111/bjh.13832. Epub 2015 Nov 18.

    PubMed 26577691

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azacitidine, Entinostat and Laboratory Biomarker Analysis in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Adult Acute Myeloid Leukemia in Remission, run by National Cancer Institute (NCI) at 234 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 234 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00313586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.

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