S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
NCT ID: NCT00085709
Last Updated: 2015-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2004-07-31
2014-08-31
Brief Summary
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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.
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Detailed Description
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* Compare disease-free survival of patients with previously untreated de novo acute myeloid leukemia treated with induction therapy comprising cytarabine and daunorubicin with vs without gemtuzumab ozogamicin followed by consolidation therapy comprising high-dose cytarabine and post-consolidation therapy comprising gemtuzumab ozogamicin vs no additional therapy.
* Compare the complete remission rate in patients treated with these regimens.
* Compare the frequency and severity of the toxic effects of these regimens in these patients.
Other objectives (if funding allows):
* Determine the prognostic significance of CD33 expression on the response rate in patients receiving gemtuzumab ozogamicin.
* Determine the prognostic significance of FLT3 mutations in these patients before treatment with these regimens.
* Determine the prognostic significance of minimal residual disease in remission specimens from these patients treated with these regimens.
* Determine the prognostic significance of the flow cytometric detection of minimal residual disease in specimens collected from these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified during induction therapy according to age (\< 35 years vs ≥ 35 years) and during post-consolidation therapy according to preinduction cytogenetic risk group.
* Induction therapy: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive daunorubicin IV on days 1-3, cytarabine IV continuously on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 4. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously once daily beginning on day 15 and continuing until blood counts recover.
* Arm II: Patients receive daunorubicin, cytarabine, and G-CSF or GM-CSF as in arm I.
Patients in both arms undergo bone marrow aspiration and biopsy on day 14 (and on day 19, if applicable) and then proceed to reinduction therapy.
* Reinduction therapy: Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7. Patients also receive G-CSF or GM-CSF as in induction therapy.
Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status proceed to consolidation therapy.
* Consolidation therapy: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1, 3, and 5. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients who maintain A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after consolidation therapy proceed to post-consolidation therapy.
* Post-consolidation therapy: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 684 patients (342 per treatment arm) will be accrued for this study within 4.5-5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Post-consolidation GO
Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
gemtuzumab ozogamicin
Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart
Post-consolidation observation
Patients receive no additional therapy. Patients are observed at days 30 and 60 after randomization.
observation
No treatment given
Induction 7+3
Standard induction regimen of 7 days of Ara-C (cytosine arabinoside) and 3 days of daunomycin
Cytosine arabinoside
IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
Daunomycin
IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
Induction 7+3+GO
Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C and 3 days of daunomycin
Cytosine arabinoside
IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
Daunomycin
IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
Interventions
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gemtuzumab ozogamicin
Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart
observation
No treatment given
Cytosine arabinoside
IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
Daunomycin
IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy\* within the past 14 days
* No M3 disease NOTE: \*Patients with marked leukocytosis may be registered before the availability of biopsy results if the absolute blast count is ≥ 100,000 cells/µL
* No blastic transformation of chronic myelogenous leukemia
* No pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* Zubrod 0-3
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST and ALT ≤ 3 times ULN
* No known hepatitis B or C infection
* No known liver disease
Renal
* Not specified
Cardiovascular
* LVEF ≥ 50% by MUGA or echocardiogram
* No unstable cardiac arrhythmias
* No unstable angina
Other
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior systemic chemotherapy
* Prior hydroxyurea to control high cell counts allowed
* No more than 1 prior dose of intrathecal chemotherapy for acute leukemia
* Concurrent intrathecal chemotherapy allowed during induction therapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Stephen H. Petersdorf, MD
Role: STUDY_CHAIR
Seattle Cancer Care Alliance
Locations
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Providence Cancer Center
Anchorage, Alaska, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Peninsula Medical Center
Burlingame, California, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, United States
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
California Pacific Medical Center - California Campus
San Francisco, California, United States
Sutter Solano Medical Center
Vallejo, California, United States
Center for Cancer Care and Research at Watson Clinic, LLP
Lakeland, Florida, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States
Genesis Medical Center - West Campus
Davenport, Iowa, United States
Mercy Capitol Hospital
Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Mercy General Health Partners
Muskegon, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Independence Regional Health Center
Independence, Missouri, United States
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Parvin Radiation Oncology
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Liberty Hospital
Liberty, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Midwest Hematology Oncology Group, Incorporated
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States
Billings Clinic - Downtown
Billings, Montana, United States
St. James Healthcare Cancer Care
Butte, Montana, United States
Big Sky Oncology
Great Falls, Montana, United States
Great Falls Clinic - Main Facility
Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
St. Peter's Hospital
Helena, Montana, United States
Glacier Oncology, PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Mercy Medical Center
Springfield, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States
AnMed Cancer Center
Anderson, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
University Hospital - San Antonio
San Antonio, Texas, United States
American Fork Hospital
American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
Auburn Regional Center for Cancer Care
Auburn, Washington, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Olympic Hematology and Oncology
Bremerton, Washington, United States
Providence Centralia Hospital
Centralia, Washington, United States
St. Francis Hospital
Federal Way, Washington, United States
Columbia Basin Hematology
Kennewick, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States
Good Samaritan Cancer Center
Puyallup, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Polyclinic First Hill
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
St. Clare Hospital
Tacoma, Washington, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States
Marshfield Clinic - Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital - Huddinge
Huddinge, , Sweden
University Hospital of Linkoping
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Orebro University Hospital
Örebro, , Sweden
Karolinska University Hospital - Solna
Stockholm, , Sweden
Sundsvall Hospital
Sundsvalls, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Countries
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References
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Dillon LW, Higgins J, Nasif H, Othus M, Beppu L, Smith TH, Schmidt E, Valentine Iii CC, Salk JJ, Wood BL, Erba HP, Radich JP, Hourigan CS. Quantification of measurable residual disease using duplex sequencing in adults with acute myeloid leukemia. Haematologica. 2024 Feb 1;109(2):401-410. doi: 10.3324/haematol.2023.283520.
Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282.
Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.
Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.
Petersdorf SH, Kopecky KJ, Slovak M, Willman C, Nevill T, Brandwein J, Larson RA, Erba HP, Stiff PJ, Stuart RK, Walter RB, Tallman MS, Stenke L, Appelbaum FR. A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia. Blood. 2013 Jun 13;121(24):4854-60. doi: 10.1182/blood-2013-01-466706. Epub 2013 Apr 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S0106
Identifier Type: OTHER
Identifier Source: secondary_id
S0106
Identifier Type: -
Identifier Source: org_study_id
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