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ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

ClinicalTrials.gov ID: NCT00085709

Public ClinicalTrials.gov record NCT00085709. 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, 1:25 PM EDT

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

Official title

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Brief summary

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

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Study identification

NCT ID
NCT00085709
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
SWOG Cancer Research Network
Network
Enrollment
637 participants

Conditions and interventions

Conditions

Eligibility (public fields only)

Age range
18 Years to 60 Years
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
Jul 2004 (Type not available)
Primary completion
Mar 2010 (Actual)
Completion
Aug 2014 (Actual)
Last update posted
Sep 30, 2015

2004 – 2014

United States locations

U.S. sites
255
U.S. states
31
U.S. cities
164
Facility City State ZIP Site status
Providence Cancer Center Anchorage Alaska 99508 —
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center Fort Smith Arkansas 72903 —
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Alta Bates Summit Comprehensive Cancer Center Berkeley California 94704 —
Peninsula Medical Center Burlingame California 94010 —
Marin Cancer Institute at Marin General Hospital Greenbrae California 94904 —
Sutter Health - Western Division Cancer Research Group Greenbrae California 94904 —
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California 90089-9181 —
California Pacific Medical Center - California Campus San Francisco California 94118 —
Sutter Solano Medical Center Vallejo California 94589 —
Center for Cancer Care and Research at Watson Clinic, LLP Lakeland Florida 33805 —
Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia 31701 —
Medical Center of Central Georgia Macon Georgia 31208 —
Saint Anthony's Hospital at Saint Anthony's Health Center Alton Illinois 62002 —
St. Joseph Medical Center Bloomington Illinois 61701 —
Graham Hospital Canton Illinois 61520 —
Memorial Hospital Carthage Illinois 62321 —
Decatur Memorial Hospital Cancer Care Institute Decatur Illinois 62526 —
Eureka Community Hospital Eureka Illinois 61530 —
Galesburg Clinic, PC Galesburg Illinois 61401 —
Galesburg Cottage Hospital Galesburg Illinois 61401 —
Mason District Hospital Havana Illinois 62644 —
Hopedale Medical Complex Hopedale Illinois 61747 —
McDonough District Hospital Macomb Illinois 61455 —
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois 60153 —
Good Samaritan Regional Health Center Mount Vernon Illinois 62864 —
BroMenn Regional Medical Center Normal Illinois 61761 —
Community Cancer Center Normal Illinois 61761 —
Community Hospital of Ottawa Ottawa Illinois 61350 —
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois 61350 —
Cancer Treatment Center at Pekin Hospital Pekin Illinois 61554 —
Proctor Hospital Peoria Illinois 61614 —
CCOP - Illinois Oncology Research Association Peoria Illinois 61615 —
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois 61615 —
Methodist Medical Center of Illinois Peoria Illinois 61636 —
OSF St. Francis Medical Center Peoria Illinois 61637 —
Illinois Valley Community Hospital Peru Illinois 61354 —
Perry Memorial Hospital Princeton Illinois 61356 —
St. Margaret's Hospital Spring Valley Illinois 61362 —
Regional Cancer Center at Memorial Medical Center Springfield Illinois 62781-0001 —
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana 46107 —
Reid Hospital & Health Care Services Richmond Indiana 47374 —
McFarland Clinic, PC Ames Iowa 50010 —
Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa 52803 —
Genesis Medical Center - West Campus Davenport Iowa 52804 —
Mercy Capitol Hospital Des Moines Iowa 50307 —
CCOP - Iowa Oncology Research Association Des Moines Iowa 50309 —
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa 50309 —
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa 50309 —
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa 50314 —
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa 50314 —
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa 50316 —
Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa 51101 —
Mercy Medical Center - Sioux City Sioux City Iowa 51104 —
St. Luke's Regional Medical Center Sioux City Iowa 51104 —
Cancer Center of Kansas, PA - Chanute Chanute Kansas 66720 —
Cancer Center of Kansas, PA - Dodge City Dodge City Kansas 67801 —
Cancer Center of Kansas, PA - El Dorado El Dorado Kansas 67042 —
Cancer Center of Kansas-Independence Independence Kansas 67301 —
Cancer Center of Kansas, PA - Kingman Kingman Kansas 67068 —
Lawrence Memorial Hospital Lawrence Kansas 66044 —
Southwest Medical Center Liberal Kansas 67901 —
Cancer Center of Kansas, PA - Newton Newton Kansas 67114 —
Menorah Medical Center Overland Park Kansas 66209 —
Cancer Center of Kansas, PA - Parsons Parsons Kansas 67357 —
Cancer Center of Kansas, PA - Pratt Pratt Kansas 67124 —
Cancer Center of Kansas, PA - Salina Salina Kansas 67042 —
Shawnee Mission Medical Center Shawnee Mission Kansas 66204 —
Cotton-O'Neil Cancer Center Topeka Kansas 66606 —
Cancer Center of Kansas, PA - Wellington Wellington Kansas 67152 —
Associates in Womens Health, PA - North Review Wichita Kansas 67208 —
Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas 67208 —
Cancer Center of Kansas, PA - Wichita Wichita Kansas 67214 —
CCOP - Wichita Wichita Kansas 67214 —
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas 67214 —
Wesley Medical Center Wichita Kansas 67214 —
Cancer Center of Kansas, PA - Winfield Winfield Kansas 67156 —
Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky 40536-0093 —
Tulane Cancer Center Office of Clinical Research Alexandria Louisiana 71315-3198 —
Pennington Cancer Center at Baton Rouge General Baton Rouge Louisiana 70806 —
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana 70809 —
MBCCOP - LSU Health Sciences Center New Orleans Louisiana 70112 —
Medical Center of Louisiana - New Orleans New Orleans Louisiana 70112 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Dana-Farber/Brigham and Women's Cancer Center Brigham and Women's Hospital Boston Massachusetts 02115 —
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts 02115 —
Caritas St. Elizabeth's Medical Center Brighton Massachusetts 02135-2997 —
Saint Joseph Mercy Cancer Center Ann Arbor Michigan 48106-0995 —
CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan 48106 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109-0942 —
Battle Creek Health System Cancer Care Center Battle Creek Michigan 49017 —
Mecosta County Medical Center Big Rapids Michigan 49307 —
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan 48123-2500 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-1379 —
Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan 48202 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Hurley Medical Center Flint Michigan 48503 —
Butterworth Hospital at Spectrum Health Grand Rapids Michigan 49503 —
CCOP - Grand Rapids Grand Rapids Michigan 49503 —
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan 49503 —
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 —
Foote Memorial Hospital Jackson Michigan 49201 —
Borgess Medical Center Kalamazoo Michigan 49001 —
West Michigan Cancer Center Kalamazoo Michigan 49007-3731 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
Sparrow Regional Cancer Center Lansing Michigan 48912-1811 —
St. Mary Mercy Hospital Livonia Michigan 48154 —
Mercy General Health Partners Muskegon Michigan 49443 —
St. Joseph Mercy Oakland Pontiac Michigan 48341-2985 —
Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan 48060 —
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan 48601 —
Providence Cancer Institute at Providence Hospital - Southfield Campus Southfield Michigan 48075 —
Munson Medical Center Traverse City Michigan 49684 —
St. John Macomb Hospital Warren Michigan 48093 —
Metro Health Hospital Wyoming Michigan 49519 —
Duluth Clinic Cancer Center - Duluth Duluth Minnesota 55805-1983 —
CCOP - Duluth Duluth Minnesota 55805 —
Miller - Dwan Medical Center Duluth Minnesota 55805 —
University of Mississippi Cancer Clinic Jackson Mississippi 39216 —
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Cape Girardeau Missouri 63701 —
Saint Francis Medical Center Cape Girardeau Missouri 63703 —
Independence Regional Health Center Independence Missouri 64050 —
Truman Medical Center - Hospital Hill Kansas City Missouri 64108 —
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri 64111 —
St. Joseph Medical Center Kansas City Missouri 64114 —
North Kansas City Hospital Kansas City Missouri 64116 —
Parvin Radiation Oncology Kansas City Missouri 64116 —
CCOP - Kansas City Kansas City Missouri 64131 —
Research Medical Center Kansas City Missouri 64132 —
Liberty Hospital Liberty Missouri 64068 —
Heartland Regional Medical Center Saint Joseph Missouri 64506 —
Midwest Hematology Oncology Group, Incorporated St Louis Missouri 63109 —
CCOP - St. Louis-Cape Girardeau St Louis Missouri 63141 —
David C. Pratt Cancer Center at St. John's Mercy St Louis Missouri 63141 —
CCOP - Montana Cancer Consortium Billings Montana 59101 —
Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana 59101 —
Northern Rockies Radiation Oncology Center Billings Montana 59101 —
St. Vincent Healthcare Cancer Care Services Billings Montana 59101 —
Billings Clinic - Downtown Billings Montana 59107-7000 —
St. James Healthcare Cancer Care Butte Montana 59701 —
Big Sky Oncology Great Falls Montana 59405-5309 —
Great Falls Clinic - Main Facility Great Falls Montana 59405 —
Sletten Cancer Institute at Benefis Healthcare Great Falls Montana 59405 —
Not listed Great Falls Montana 59405 —
Northern Montana Hospital Havre Montana 59501 —
St. Peter's Hospital Helena Montana 59601 —
Glacier Oncology, PLLC Kalispell Montana 59901 —
Kalispell Medical Oncology at KRMC Kalispell Montana 59901 —
Kalispell Regional Medical Center Kalispell Montana 59901 —
Community Medical Center Missoula Montana 59801 —
Guardian Oncology and Center for Wellness Missoula Montana 59804 —
Montana Cancer Specialists at Montana Cancer Center Missoula Montana 59807-7877 —
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana 59807 —
Methodist Estabrook Cancer Center Omaha Nebraska 68114 —
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska 68198-6805 —
University Medical Center of Southern Nevada Las Vegas Nevada 89102 —
CCOP - Nevada Cancer Research Foundation Las Vegas Nevada 89106 —
Sunrise Hospital and Medical Center Las Vegas Nevada 89109 —
University of New Mexico Cancer Center Albuquerque New Mexico 87131-5636 —
New Mexico Cancer Care Associates Santa Fe New Mexico 87505 —
Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina 28233-3549 —
Kinston Medical Specialists Kinston North Carolina 28501 —
Rutherford Hospital Rutherfordton North Carolina 28139 —
McDowell Cancer Center at Akron General Medical Center Akron Ohio 44307 —
Mary Rutan Hospital Bellefontaine Ohio 43311 —
Mercy Cancer Center at Mercy Medical Center Canton Ohio 44708 —
Aultman Cancer Center at Aultman Hospital Canton Ohio 44710-1799 —
Adena Regional Medical Center Chillicothe Ohio 45601 —
Riverside Methodist Hospital Cancer Care Columbus Ohio 43214-3998 —
CCOP - Columbus Columbus Ohio 43215 —
Grant Medical Center Cancer Care Columbus Ohio 43215 —
Mount Carmel Health - West Hospital Columbus Ohio 43222 —
Doctors Hospital at Ohio Health Columbus Ohio 43228 —
Grandview Hospital Dayton Ohio 45405 —
Good Samaritan Hospital Dayton Ohio 45406 —
David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio 45409 —
CCOP - Dayton Dayton Ohio 45429 —
Grady Memorial Hospital Delaware Ohio 43015 —
Blanchard Valley Medical Associates Findlay Ohio 45840 —
Middletown Regional Hospital Franklin Ohio 45005-1066 —
Charles F. Kettering Memorial Hospital Kettering Ohio 45429 —
Fairfield Medical Center Lancaster Ohio 43130 —
St. Rita's Medical Center Lima Ohio 45801 —
Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio 45750 —
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio 43055 —
Mercy Medical Center Springfield Ohio 45504 —
Community Hospital of Springfield and Clark County Springfield Ohio 45505 —
UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio 45373-1300 —
Mount Carmel St. Ann's Cancer Center Westerville Ohio 43081 —
Clinton Memorial Hospital Wilmington Ohio 45177 —
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio 45385 —
Genesis - Good Samaritan Hospital Zanesville Ohio 43701 —
Lancaster General Hospital Lancaster Pennsylvania 17604 —
Guthrie Cancer Center at Guthrie Clinic Sayre Sayre Pennsylvania 18840 —
Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania 18501 —
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania 18510 —
AnMed Cancer Center Anderson South Carolina 29621 —
Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina 29425 —
McLeod Regional Medical Center Florence South Carolina 29501 —
CCOP - Upstate Carolina Spartanburg South Carolina 29303 —
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina 29303 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
Medical X-Ray Center, PC Sioux Falls South Dakota 57105 —
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota 57117-5039 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229-3900 —
Cancer Therapy and Research Center San Antonio Texas 78229 —
University Hospital - San Antonio San Antonio Texas 78229 —
American Fork Hospital American Fork Utah 84003 —
Sandra L. Maxwell Cancer Center Cedar City Utah 84720 —
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray Utah 84157 —
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden Utah 84403 —
Utah Valley Regional Medical Center - Provo Provo Utah 84604 —
LDS Hospital Salt Lake City Utah 84103 —
Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah 84106 —
Huntsman Cancer Institute at University of Utah Salt Lake City Utah 84112 —
Dixie Regional Medical Center - East Campus St. George Utah 84770 —
Auburn Regional Center for Cancer Care Auburn Washington 98002 —
St. Joseph Cancer Center Bellingham Washington 98225 —
Olympic Hematology and Oncology Bremerton Washington 98310 —
Providence Centralia Hospital Centralia Washington 98531-9027 —
St. Francis Hospital Federal Way Washington 98003 —
Columbia Basin Hematology Kennewick Washington 99336 —
Providence St. Peter Hospital Regional Cancer Center Olympia Washington 98506-5166 —
Good Samaritan Cancer Center Puyallup Washington 98372 —
Fred Hutchinson Cancer Research Center Seattle Washington 98104 —
Harborview Medical Center Seattle Washington 98104 —
Group Health Central Hospital Seattle Washington 98112 —
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington 98122-4307 —
Polyclinic First Hill Seattle Washington 98122 —
University Cancer Center at University of Washington Medical Center Seattle Washington 98195-6043 —
Cancer Care Northwest - Spokane South Spokane Washington 99202 —
Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington 98405-3004 —
Allenmore Hospital Tacoma Washington 98405 —
CCOP - Northwest Tacoma Washington 98405 —
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington 98405 —
Madigan Army Medical Center - Tacoma Tacoma Washington 98431 —
St. Clare Hospital Tacoma Washington 98499 —
West Virginia University Health Sciences Center - Charleston Charleston West Virginia 25304 —
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg West Virginia 26102 —
Marshfield Clinic - Chippewa Center Chippewa Falls Wisconsin 54729 —
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin 54701 —
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54301-3526 —
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin 54303 —
St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin 54303 —
St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin 54307-3508 —
Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin 54143 —
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449 —
Froedtert Hospital and Medical College of Wisconsin Milwaukee Wisconsin 53226 —
Medical College of Wisconsin Cancer Center Milwaukee Wisconsin 53226 —
Marshfield Clinic - Lakeland Center Minocqua Wisconsin 54548 —
Marshfield Clinic - Indianhead Center Rice Lake Wisconsin 54868 —
Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin 53188 —
Marshfield Clinic - Weston Center Weston Wisconsin 54476 —
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin 54494 —
Welch Cancer Center at Sheridan Memorial Hospital 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 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00085709, 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 Sep 30, 2015 · Synced Oct 25, 2026

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Open the official record

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