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ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

ClinicalTrials.gov ID: NCT02085408

Public ClinicalTrials.gov record NCT02085408. 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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 3:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Study identification

NCT ID
NCT02085408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
727 participants

Conditions and interventions

Eligibility (public fields only)

Age range
60 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
Feb 4, 2011 (Actual)
Primary completion
Feb 22, 2021 (Actual)
Completion
Dec 21, 2022 (Actual)
Last update posted
Dec 13, 2024

2011 – 2022

United States locations

U.S. sites
266
U.S. states
38
U.S. cities
184
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 —
Mayo Clinic in Arizona Scottsdale Arizona 85259 —
Arizona Cancer Center at University Medical Center North Tucson Arizona 85719 —
University of Arizona Health Sciences Center Tucson Arizona 85724 —
The Medical Center of Aurora Aurora Colorado 80012 —
Boulder Community Hospital Boulder Colorado 80301 —
Penrose-Saint Francis Healthcare Colorado Springs Colorado 80907 —
Saint Anthony Central Hospital Denver Colorado 80204 —
Porter Adventist Hospital Denver Colorado 80210 —
Exempla Saint Joseph Hospital Denver Colorado 80218 —
Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado 80218 —
Rose Medical Center Denver Colorado 80220 —
Colorado Cancer Research Program CCOP Denver Colorado 80224-2522 —
Swedish Medical Center Englewood Colorado 80110 —
North Colorado Medical Center Greeley Colorado 80631 —
Littleton Adventist Hospital Littleton Colorado 80122 —
Sky Ridge Medical Center Lone Tree Colorado 80124 —
Longmont United Hospital Longmont Colorado 80501 —
McKee Medical Center Loveland Colorado 80539 —
Parker Adventist Hospital Parker Colorado 80138 —
Saint Mary Corwin Medical Center Pueblo Colorado 81004 —
North Suburban Medical Center Thornton Colorado 80229 —
Exempla Lutheran Medical Center Wheat Ridge Colorado 80033 —
Saint Francis Hospital and Medical Center Hartford Connecticut 06105 —
The Hospital of Central Connecticut New Britain Connecticut 06050 —
Beebe Medical Center Lewes Delaware 19958 —
Christiana Care Health System-Christiana Hospital Newark Delaware 19718 —
University of Florida Gainesville Florida 32610 —
Mayo Clinic in Florida Jacksonville Florida 32224-9980 —
Florida Hospital Orlando Florida 32803 —
Piedmont Hospital Atlanta Georgia 30309 —
Atlanta Regional CCOP Atlanta Georgia 30342 —
Northside Hospital Atlanta Georgia 30342 —
Saint Joseph's Hospital of Atlanta Atlanta Georgia 30342 —
Georgia Regents University Augusta Georgia 30912 —
Well Star Cobb Hospital Austell Georgia 30106 —
John B Amos Cancer Center Columbus Georgia 31904 —
Dekalb Medical Center Decatur Georgia 30033 —
Piedmont Fayette Hospital Fayetteville Georgia 30214 —
Gwinnett Medical Center Lawrenceville Georgia 30045 —
Wellstar Kennestone Hospital Marietta Georgia 30060 —
Southern Regional Medical Center Riverdale Georgia 30274 —
Harbin Clinic Medical Oncology and Clinical Research Rome Georgia 30165 —
Oncare Hawaii Inc-POB II Honolulu Hawaii 96813 —
Queen's Medical Center Honolulu Hawaii 96813 —
Straub Clinic and Hospital Honolulu Hawaii 96813 —
University of Hawaii Honolulu Hawaii 96813 —
OnCare Hawaii-Liliha Honolulu Hawaii 96817-3169 —
Kuakini Medical Center Honolulu Hawaii 96817 —
Oncare Hawaii Inc-Kuakini Honolulu Hawaii 96817 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Castle Medical Center Kailua Hawaii 96734 —
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii 96766 —
Kapiolani Medical Center at Pali Momi ‘Aiea Hawaii 96701 —
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi ‘Aiea Hawaii 96701 —
Saint Alphonsus Regional Medical Center Boise Idaho 83706 —
Saint Anthony's Health Alton Illinois 62002 —
Illinois CancerCare-Bloomington Bloomington Illinois 61701 —
Saint Joseph Medical Center Bloomington Illinois 61701 —
Graham Hospital Association Canton Illinois 61520 —
Illinois CancerCare-Canton Canton Illinois 61520 —
Illinois CancerCare-Carthage Carthage Illinois 62321 —
Memorial Hospital Carthage Illinois 62321 —
Mount Sinai Hospital Medical Center Chicago Illinois 60608 —
Hematology and Oncology Associates Chicago Illinois 60611 —
Northwestern University Chicago Illinois 60611 —
University of Illinois Chicago Illinois 60612 —
Decatur Memorial Hospital Decatur Illinois 62526 —
Eureka Hospital Eureka Illinois 61530 —
Illinois CancerCare-Eureka Eureka Illinois 61530 —
Illinois CancerCare Galesburg Galesburg Illinois 61401 —
Western Illinois Cancer Treatment Center Galesburg Illinois 61401 —
Illinois CancerCare-Havana Havana Illinois 62644 —
Mason District Hospital Havana Illinois 62644 —
Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois 60035 —
Hinsdale Hematology Oncology Associates Incorporated Hinsdale Illinois 60521 —
Presence Saint Mary's Hospital Kankakee Illinois 60901 —
Illinois CancerCare-Kewanee Clinic Kewanee Illinois 61443 —
North Shore Hematology Oncology 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 —
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 —
Pekin Cancer Treatment Center Pekin Illinois 61554 —
Illinois CancerCare-Pekin Pekin Illinois 61603 —
Methodist Medical Center of Illinois Peoria Illinois 61603 —
Proctor Hospital Peoria Illinois 61614 —
Illinois CancerCare-Peoria Peoria Illinois 61615 —
Illinois Oncology Research Association CCOP 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 —
Hematology Oncology Associates of Illinois - Skokie Skokie Illinois 60076 —
Illinois CancerCare-Spring Valley Spring Valley Illinois 61362 —
Memorial Medical Center Springfield Illinois 62781-0001 —
Saint Francis Hospital and Health Centers Beech Grove Indiana 46107 —
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard Fort Wayne Indiana 46845 —
Franciscan St. Francis Health Indianapolis Indiana 46237 —
Reid Hospital and Health Care Services Richmond Indiana 47374 —
McFarland Clinic Ames Iowa 50010 —
Siouxland Hematology Oncology Associates Sioux City Iowa 51101 —
Mercy Medical Center-Sioux City Sioux City Iowa 51104 —
Saint Luke's Regional Medical Center Sioux City Iowa 51104 —
University of Kentucky Lexington Kentucky 40536 —
Norton Health Care Pavilion - Downtown Louisville Kentucky 40202 —
Ochsner Clinic Foundation-Baton Rouge Baton Rouge Louisiana 70809 —
Ochsner Baptist Medical Center New Orleans Louisiana 70115 —
Ochsner Clinic Foundation New Orleans Louisiana 70121 —
Harold Alfond Center for Cancer Care Augusta Maine 04330 —
Eastern Maine Medical Center Bangor Maine 04401 —
Johns Hopkins University Baltimore Maryland 21287-8936 —
Walter Reed National Military Medical Center Bethesda Maryland 20889-5600 —
Union Hospital of Cecil County Elkton Maryland 21921 —
Tufts Medical Center Boston Massachusetts 02111 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Caritas Saint Elizabeth's Medical Center Brighton Massachusetts 02135-2997 —
Baystate Medical Center Springfield Massachusetts 01199 —
Saint Joseph Mercy Hospital Ann Arbor Michigan 48106-0995 —
Michigan Cancer Research Consortium Community Clinical Oncology Program Ann Arbor Michigan 48106 —
Bronson Battle Creek Battle Creek Michigan 49017 —
Mecosta County Medical Center Big Rapids Michigan 49307 —
Oakwood Hospital Dearborn Michigan 48124 —
Wayne State University Detroit Michigan 48202 —
Saint John Hospital and Medical Center Detroit Michigan 48236 —
Hurley Medical Center Flint Michigan 48502 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Genesys Regional Medical Center-West Flint Campus Flint Michigan 48532 —
Genesys Regional Medical Center Grand Blanc Michigan 48439 —
Grand Rapids Clinical Oncology Program Grand Rapids Michigan 49503 —
Saint Mary's Health Care Grand Rapids Michigan 49503 —
Spectrum Health at Butterworth Campus Grand Rapids Michigan 49503 —
Allegiance Health Jackson Michigan 49201 —
Borgess Medical Center Kalamazoo Michigan 49001 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
West Michigan Cancer Center Kalamazoo Michigan 49007 —
Sparrow Hospital Lansing Michigan 48912 —
Saint Mary Mercy Hospital Livonia Michigan 48154 —
Mercy Health Partners-Mercy Campus Muskegon Michigan 49444 —
Saint Joseph Mercy Oakland Pontiac Michigan 48341-2985 —
Saint Joseph Mercy Port Huron Port Huron Michigan 48060 —
Spectrum Health Reed City Hospital Reed City Michigan 49677 —
Saint Mary's of Michigan Saginaw Michigan 48601 —
Providence Hospital Southfield Michigan 48075 —
Munson Medical Center Traverse City Michigan 49684 —
Saint John Macomb-Oakland Hospital Warren Michigan 48093 —
Sanford Clinic North-Bemidgi Bemidji Minnesota 56601 —
Essentia Health Saint Joseph's Medical Center Brainerd Minnesota 56401 —
Essentia Health Duluth Clinic CCOP Duluth Minnesota 55805 —
Essentia Health Saint Mary's Medical Center Duluth Minnesota 55805 —
Miller-Dwan Hospital Duluth Minnesota 55805 —
Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota 56537 —
Mayo Clinic Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Saint Francis Medical Center Cape Girardeau Missouri 63703 —
Saint Louis Cancer and Breast Institute-South City St Louis Missouri 63109 —
Saint Louis University Hospital St Louis Missouri 63110 —
Washington University School of Medicine St Louis Missouri 63110 —
Saint John's Mercy Medical Center St Louis Missouri 63141 —
Saint Louis-Cape Girardeau CCOP St Louis Missouri 63141 —
Montana Cancer Consortium CCOP Billings Montana 59101 —
Saint Vincent Healthcare Billings Montana 59101 —
Hematology-Oncology Centers of the Northern Rockies PC Billings Montana 59102 —
Billings Clinic Billings Montana 59107-7000 —
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 —
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 —
Nevada Cancer Research Foundation CCOP Las Vegas Nevada 89106 —
Cooper Hospital University Medical Center Camden New Jersey 08103 —
Winthrop University Hospital Mineola New York 11501 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
University of Rochester Rochester New York 14642 —
Park Ridge Hospital Breast Health Center Hendersonville North Carolina 28792 —
Kinston Medical Specialists PA Kinston North Carolina 28501 —
Roger Maris Cancer Center Fargo North Dakota 58122 —
Sanford Clinic North-Fargo Fargo North Dakota 58122 —
Sanford Medical Center-Fargo Fargo North Dakota 58122 —
Summa Akron City Hospital Akron Ohio 44304 —
Akron General Medical Center Akron Ohio 44307 —
Summa Barberton Hospital Barberton Ohio 44203 —
Aultman Health Foundation Canton Ohio 44710 —
The Jewish Hospital Cincinnati Ohio 45236 —
Case Western Reserve University Cleveland Ohio 44106 —
Grandview Hospital Dayton Ohio 45405 —
Good Samaritan Hospital - Dayton Dayton Ohio 45406 —
Miami Valley Hospital Dayton Ohio 45409 —
Samaritan North Health Center Dayton Ohio 45415 —
Dayton CCOP Dayton Ohio 45420 —
Blanchard Valley Hospital Findlay Ohio 45840 —
Atrium Medical Center-Middletown Regional Hospital Franklin Ohio 45005-1066 —
Wayne Hospital Greenville Ohio 45331 —
Kettering Medical Center Kettering Ohio 45429 —
Saint Rita's Medical Center Lima Ohio 45801 —
Upper Valley Medical Center Troy Ohio 45373 —
Clinton Memorial Hospital Wilmington Ohio 45177 —
Greene Memorial Hospital Xenia Ohio 45385 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Clackamas Radiation Oncology Center Clackamas Oregon 97015 —
Providence Milwaukie Hospital Milwaukie Oregon 97222 —
Providence Newberg Medical Center Newberg Oregon 97132 —
Providence Willamette Falls Medical Center Oregon City Oregon 97045 —
Providence Portland Medical Center Portland Oregon 97213 —
Columbia River Oncology Program Portland Oregon 97225 —
Providence Saint Vincent Medical Center Portland Oregon 97225 —
Lehigh Valley Hospital Allentown Pennsylvania 18105 —
Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania 18017 —
Geisinger Medical Center Danville Pennsylvania 17822-2001 —
Geisinger Medical Center-Cancer Center Hazelton Hazleton Pennsylvania 18201 —
Penn State Milton S Hershey Medical Center Hershey Pennsylvania 17033-0850 —
Lewistown Hospital Lewistown Pennsylvania 17044 —
Abramson Cancer Center of The University of Pennsylvania Philadelphia Pennsylvania 19104 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111-2497 —
Geisinger Medical Group State College Pennsylvania 16801 —
Mount Nittany Medical Center State College Pennsylvania 16803 —
Geisinger Wyoming Valley Wilkes-Barre Pennsylvania 18711 —
York Hospital York Pennsylvania 17405 —
AnMed Health Cancer Center Anderson South Carolina 29621 —
Saint Francis Hospital Greenville South Carolina 29601 —
Carolina Blood and Cancer Care Associates PA-Lancaster Lancaster South Carolina 29720 —
Carolina Blood and Cancer Care Associates PA Rock Hill South Carolina 29732 —
Spartanburg Regional Medical Center Spartanburg South Carolina 29303 —
Upstate Carolina CCOP Spartanburg South Carolina 29303 —
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 —
Erlanger Medical Center Chattanooga Tennessee 37403 —
Jackson-Madison County General Hospital Jackson Tennessee 38301 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
PeaceHealth Southwest Medical Center Vancouver Washington 98664 —
Northwest Cancer Specialists Vancouver Washington 98684 —
West Virginia University Charleston Charleston West Virginia 25304 —
West Virginia University Morgantown West Virginia 26506 —
Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin 54301-3526 —
Saint Vincent Hospital Green Bay Wisconsin 54301 —
Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin 54303 —
Saint Mary's Hospital Green Bay Wisconsin 54303 —
Gundersen Lutheran La Crosse Wisconsin 54601 —
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 —
Holy Family Memorial Hospital Manitowoc Wisconsin 54221 —
Bay Area Medical Center Marinette Wisconsin 54143 —
Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin 53226 —
D N Greenwald Center Mukwonago Wisconsin 53149 —
Oconomowoc Memorial Hospital-ProHealth Care Inc Oconomowoc Wisconsin 53066-3896 —
Saint Nicholas Hospital Sheboygan Wisconsin 53081 —
Waukesha Memorial Hospital - ProHealth Care Waukesha Wisconsin 53188 —
Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin 53226 —
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.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02085408, 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 Dec 13, 2024 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02085408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →