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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azacitidine
Entinostat
Laboratory Biomarker Analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Arizona
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Los Angeles Oncology Institute
  • Stanford Cancer Institute
  • Sutter Roseville Medical Center
  • Sutter General Hospital
  • The Medical Center of Aurora
  • Boulder Community Hospital
  • Penrose-Saint Francis Healthcare
  • Porter Adventist Hospital
  • Presbyterian - Saint Lukes Medical Center - Health One
  • SCL Health Saint Joseph Hospital
  • Rose Medical Center
  • Colorado Cancer Research Program NCORP
  • Swedish Medical Center
  • Poudre Valley Hospital
  • Front Range Cancer Specialists
  • Saint Mary's Hospital and Regional Medical Center
  • North Colorado Medical Center
  • Saint Anthony Hospital
  • Sky Ridge Medical Center
  • Longmont United Hospital
  • McKee Medical Center
  • Saint Mary Corwin Medical Center
  • North Suburban Medical Center
  • SCL Health Lutheran Medical Center
  • Beebe Medical Center
  • Christiana Care Health System-Christiana Hospital
  • Sibley Memorial Hospital
  • Emory University/Winship Cancer Institute
  • Rush - Copley Medical Center
  • MacNeal Hospital and Cancer Center
  • Saint Joseph Medical Center
  • Illinois CancerCare-Bloomington
  • Graham Hospital Association
  • Illinois CancerCare-Canton
  • Illinois CancerCare-Carthage
  • Memorial Hospital
  • Hematology and Oncology Associates
  • Northwestern University
  • Jesse Brown Veterans Affairs Medical Center
  • John H Stroger Jr Hospital of Cook County
  • University of Illinois
  • Mercy Hospital and Medical Center
  • University of Chicago Comprehensive Cancer Center
  • Weiss Memorial Hospital
  • Presence Saint Joseph Hospital-Chicago
  • Decatur Memorial Hospital
  • Heartland Cancer Research NCORP
  • Eureka Hospital
  • Illinois CancerCare-Eureka
  • NorthShore University HealthSystem-Evanston Hospital
  • Galesburg Cottage Hospital
  • Illinois CancerCare-Galesburg
  • Illinois CancerCare-Havana
  • Mason District Hospital
  • Hopedale Medical Complex - Hospital
  • Midwest Center for Hematology Oncology
  • Joliet Oncology-Hematology Associates Limited
  • Illinois CancerCare-Kewanee Clinic
  • NorthShore Hematology Oncology-Libertyville
  • Illinois CancerCare-Macomb
  • Mcdonough District Hospital
  • Loyola University Medical Center
  • Holy Family Medical Center
  • Illinois CancerCare-Monmouth
  • DuPage Medical Group-Ogden
  • Illinois Cancer Specialists-Niles
  • Bromenn Regional Medical Center
  • Community Cancer Center Foundation
  • Illinois CancerCare-Community Cancer Center
  • Illinois CancerCare-Ottawa Clinic
  • Ottawa Regional Hospital and Healthcare Center
  • Illinois CancerCare-Pekin
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Pekin Hospital
  • Methodist Medical Center of Illinois
  • Proctor Hospital
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Illinois Valley Hospital
  • Illinois CancerCare-Princeton
  • Perry Memorial Hospital
  • Swedish American Hospital
  • SwedishAmerican Regional Cancer Center/ACT
  • Edward H Kaplan MD and Associates
  • Hematology Oncology Associates of Illinois - Skokie
  • Illinois CancerCare-Spring Valley
  • Saint Margaret's Hospital
  • Memorial Medical Center
  • Carle Clinic-Urbana Main
  • Fort Wayne Medical Oncology and Hematology Inc-Parkview
  • Franciscan Saint Anthony Health-Michigan City
  • McFarland Clinic PC-William R Bliss Cancer Center
  • Medical Oncology and Hematology Associates-West Des Moines
  • Mercy Capitol
  • Iowa Methodist Medical Center
  • Iowa-Wide Oncology Research Coalition NCORP
  • Medical Oncology and Hematology Associates-Des Moines
  • Medical Oncology and Hematology Associates-Laurel
  • Mercy Medical Center - Des Moines
  • Iowa Lutheran Hospital
  • University of Iowa/Holden Comprehensive Cancer Center
  • Siouxland Regional Cancer Center
  • Mercy Medical Center-Sioux City
  • Saint Luke's Regional Medical Center
  • Hospital District Sixth of Harper County
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Providence Medical Center
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas - Newton
  • Menorah Medical Center
  • Radiation Oncology Practice Corporation Southwest
  • Saint Luke's South Hospital
  • Cancer Center of Kansas - Parsons
  • Kansas City NCI Community Oncology Research Program
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Salina Regional Health Center
  • Shawnee Mission Medical Center-KCCC
  • Saint Francis Hospital and Medical Center - Topeka
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Via Christi Regional Medical Center
  • Wichita NCI Community Oncology Research Program
  • Cancer Center of Kansas - Winfield
  • Eastern Maine Medical Center
  • University of Maryland/Greenebaum Cancer Center
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Union Hospital of Cecil County
  • Boston Medical Center
  • Henry Ford Hospital
  • Sanford Clinic North-Bemidgi
  • Lake Region Healthcare Corporation-Cancer Care
  • University of Minnesota/Masonic Cancer Center
  • Mayo Clinic
  • Southeast Missouri Hospital
  • Veterans Administration
  • University of Missouri - Ellis Fischel
  • Centerpoint Medical Center LLC
  • Truman Medical Center
  • Saint Luke's Cancer Institute
  • Saint Luke's Hospital of Kansas City
  • Radiation Oncology Practice Corporation South
  • Saint Joseph Health Center
  • North Kansas City Hospital
  • Heartland Hematology and Oncology Associates Incorporated
  • Research Medical Center
  • Radiation Oncology Practice Corporation - North
  • Saint Luke's East - Lee's Summit
  • Liberty Hospital
  • Liberty Radiation Oncology Center
  • Heartland Regional Medical Center
  • Saint Joseph Oncology Inc
  • Saint Louis University Hospital
  • Billings Clinic Cancer Center
  • Montana Cancer Consortium NCORP
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Frontier Cancer Center and Blood Institute-Billings
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer Institute
  • Berdeaux, Donald MD (UIA Investigator)
  • Big Sky Oncology
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Community Medical Hospital
  • Guardian Oncology and Center for Wellness
  • Ocean Medical Center
  • Cooper Hospital University Medical Center
  • Presbyterian Kaseman Hospital
  • Montefiore Medical Center-Weiler Hospital
  • Montefiore Medical Center - Moses Campus
  • Roswell Park Cancer Institute
  • Adirondack Cancer Center
  • Northwell Health NCORP
  • North Shore University Hospital
  • Orange Regional Medical Center
  • Long Island Jewish Medical Center
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Mount Sinai Medical Center
  • Carolinas Medical Center/Levine Cancer Institute
  • East Carolina University
  • Kinston Medical Specialists PA
  • Wake Forest University Health Sciences
  • Sanford Clinic North-Fargo
  • Sanford Medical Center-Fargo
  • Akron General Medical Center
  • Case Western Reserve University
  • Bryn Mawr Hospital
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Paoli Memorial Hospital
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute (UPCI)
  • Mercy Hospital
  • Scranton Hematology Oncology
  • Geisinger Medical Group
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Lankenau Medical Center
  • Main Line Health NCORP
  • WellSpan Health-York Hospital
  • Sanford Cancer Center-Oncology Clinic
  • Medical X-Ray Center
  • Sanford USD Medical Center - Sioux Falls
  • Jackson-Madison County General Hospital
  • University of Tennessee - Knoxville
  • Zale Lipshy University Hospital
  • Clements University Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Scott and White Memorial Hospital
  • Cottonwood Hospital Medical Center
  • Danville Regional Medical Center
  • University of Wisconsin Hospital and Clinics
  • Medical Consultants Limited
  • Rocky Mountain Oncology
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (azacitidine)

Arm B (azacitidine, entinostat)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2006
Last Updated
December 8, 2016
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00313586
Brief Title
Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (azacitidine)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B (azacitidine, entinostat)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza
Intervention Description
Given SC
Intervention Type
Drug
Intervention Name(s)
Entinostat
Other Intervention Name(s)
HDAC inhibitor SNDX-275, MS 27-275, MS-275, SNDX-275
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Proportion of Patients With Clinical Response
Description
Clinical response is defined as a complete response (CR), partial response (PR) or trilineage response (TR) graded according to the following criteria: World Health Organization classification of the acute leukemias and myelodysplastic syndrome (by Bennett) Myelodysplastic syndromes standardized response criteria: further definition (by Cheson et al.) Report of an international working group to standardize response criteria for myelodysplastic syndromes (by Cheson et al.)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Gore
Organizational Affiliation
ECOG-ACRIN Cancer Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Los Angeles Oncology Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
The Medical Center of Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - Saint Lukes Medical Center - Health One
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
SCL Health Saint Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Colorado Cancer Research Program NCORP
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Front Range Cancer Specialists
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Saint Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
Saint Mary Corwin Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
SCL Health Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
MacNeal Hospital and Cancer Center
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Graham Hospital Association
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Hematology and Oncology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jesse Brown Veterans Affairs Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Presence Saint Joseph Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Heartland Cancer Research NCORP
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Eureka Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
NorthShore University HealthSystem-Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Hopedale Medical Complex - Hospital
City
Hopedale
State/Province
Illinois
ZIP/Postal Code
61747
Country
United States
Facility Name
Midwest Center for Hematology Oncology
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States
Facility Name
Joliet Oncology-Hematology Associates Limited
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
NorthShore Hematology Oncology-Libertyville
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Mcdonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Holy Family Medical Center
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
Illinois CancerCare-Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
DuPage Medical Group-Ogden
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Illinois Cancer Specialists-Niles
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Bromenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center Foundation
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Ottawa Regional Hospital and Healthcare Center
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Swedish American Hospital
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104
Country
United States
Facility Name
SwedishAmerican Regional Cancer Center/ACT
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Edward H Kaplan MD and Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Hematology Oncology Associates of Illinois - Skokie
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Illinois CancerCare-Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Saint Margaret's Hospital
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Carle Clinic-Urbana Main
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology Inc-Parkview
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Franciscan Saint Anthony Health-Michigan City
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
McFarland Clinic PC-William R Bliss Cancer Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Capitol
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50307
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa-Wide Oncology Research Coalition NCORP
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center-Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Saint Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Hospital District Sixth of Harper County
City
Anthony
State/Province
Kansas
ZIP/Postal Code
67003
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Providence Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Radiation Oncology Practice Corporation Southwest
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Kansas City NCI Community Oncology Research Program
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Shawnee Mission Medical Center-KCCC
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Saint Francis Hospital and Medical Center - Topeka
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wichita NCI Community Oncology Research Program
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Maryland/Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Sanford Clinic North-Bemidgi
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Lake Region Healthcare Corporation-Cancer Care
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Southeast Missouri Hospital
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Veterans Administration
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
University of Missouri - Ellis Fischel
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Radiation Oncology Practice Corporation South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Saint Joseph Health Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Heartland Hematology and Oncology Associates Incorporated
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Radiation Oncology Practice Corporation - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Liberty Hospital
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Liberty Radiation Oncology Center
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Joseph Oncology Inc
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Montana Cancer Consortium NCORP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Frontier Cancer Center and Blood Institute-Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Berdeaux, Donald MD (UIA Investigator)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Ocean Medical Center
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Presbyterian Kaseman Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
Montefiore Medical Center-Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Adirondack Cancer Center
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Northwell Health NCORP
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Kinston Medical Specialists PA
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Clinic North-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Medical Center-Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Geisinger Medical Center-Cancer Center Hazleton
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Mercy Hospital
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18501
Country
United States
Facility Name
Scranton Hematology Oncology
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
Geisinger Medical Group
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Geisinger Wyoming Valley/Henry Cancer Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Main Line Health NCORP
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
WellSpan Health-York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Sanford Cancer Center-Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Medical X-Ray Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Jackson-Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
University of Tennessee - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Zale Lipshy University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Clements University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical Consultants Limited
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26577691
Citation
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.
Results Reference
derived

Learn more about this trial

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

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