Leukemia Clinical Trial
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)
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.
Status | Completed |
Enrollment | 637 |
Est. completion date | August 2014 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
DISEASE CHARACTERISTICS: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | Hopital Charles Lemoyne | Greenfield Park | Quebec |
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 | Moncton Hospital | Moncton | New Brunswick |
Canada | Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Canada | McGill Cancer Centre at McGill University | Montreal | Quebec |
Canada | Hopital du Saint-Sacrement - Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Canada | Cancer Care Program at Thunder Bay Regional Health Sciences | Thunder Bay | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Sweden | Sahlgrenska University Hospital | Goteborg | |
Sweden | Karolinska University Hospital - Huddinge | Huddinge | |
Sweden | University Hospital of Linkoping | Linkoping | |
Sweden | Lund University Hospital | Lund | |
Sweden | Orebro University Hospital | Orebro | |
Sweden | Karolinska University Hospital - Solna | Stockholm | |
Sweden | Sundsvall Hospital | Sundsvalls | |
Sweden | Uppsala University Hospital | Uppsala | |
United States | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio |
United States | Phoebe Cancer Center at Phoebe Putney Memorial Hospital | Albany | Georgia |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana |
United States | Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois |
United States | American Fork Hospital | American Fork | Utah |
United States | McFarland Clinic, PC | Ames | Iowa |
United States | Providence Cancer Center | Anchorage | Alaska |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Auburn Regional Center for Cancer Care | Auburn | Washington |
United States | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana |
United States | Pennington Cancer Center at Baton Rouge General | Baton Rouge | Louisiana |
United States | Battle Creek Health System Cancer Care Center | Battle Creek | Michigan |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | Mary Rutan Hospital | Bellefontaine | Ohio |
United States | St. Joseph Cancer Center | Bellingham | Washington |
United States | Alta Bates Summit Comprehensive Cancer Center | Berkeley | California |
United States | Mecosta County Medical Center | Big Rapids | Michigan |
United States | Billings Clinic - Downtown | Billings | Montana |
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 | St. Joseph Medical Center | Bloomington | Illinois |
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 | Massachusetts General Hospital | Boston | Massachusetts |
United States | Olympic Hematology and Oncology | Bremerton | Washington |
United States | Caritas St. Elizabeth's Medical Center | Brighton | Massachusetts |
United States | Peninsula Medical Center | Burlingame | California |
United States | St. James Healthcare Cancer Care | Butte | Montana |
United States | Aultman Cancer Center at Aultman Hospital | Canton | Ohio |
United States | Graham Hospital | Canton | Illinois |
United States | Mercy Cancer Center at Mercy Medical Center | Canton | Ohio |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Cape Girardeau | Missouri |
United States | Memorial Hospital | Carthage | Illinois |
United States | Sandra L. Maxwell Cancer Center | Cedar City | Utah |
United States | Providence Centralia Hospital | Centralia | Washington |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia |
United States | Presbyterian Cancer Center at Presbyterian Hospital | Charlotte | North Carolina |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Genesis Medical Center - West Campus | Davenport | Iowa |
United States | Genesis Regional Cancer Center at Genesis Medical Center | Davenport | Iowa |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | John Stoddard Cancer Center at Iowa Lutheran Hospital | 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 | Mercy Capitol Hospital | Des Moines | Iowa |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Eureka Community Hospital | Eureka | Illinois |
United States | St. Francis Hospital | Federal Way | Washington |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith | Arkansas |
United States | Galesburg Clinic, PC | Galesburg | Illinois |
United States | Galesburg Cottage Hospital | Galesburg | Illinois |
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 | 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 | Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin |
United States | Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | 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 | Marin Cancer Institute at Marin General Hospital | Greenbrae | California |
United States | Sutter Health - Western Division Cancer Research Group | Greenbrae | California |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Mason District Hospital | Havana | Illinois |
United States | Northern Montana Hospital | Havre | Montana |
United States | St. Peter's Hospital | Helena | Montana |
United States | Hopedale Medical Complex | Hopedale | Illinois |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Independence Regional Health Center | Independence | Missouri |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | University of Mississippi Cancer Clinic | Jackson | Mississippi |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
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 | CCOP - Kansas City | Kansas City | Missouri |
United States | North Kansas City Hospital | Kansas City | Missouri |
United States | Parvin Radiation Oncology | Kansas City | Missouri |
United States | Research Medical Center | 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 | Truman Medical Center - Hospital Hill | Kansas City | Missouri |
United States | Columbia Basin Hematology | Kennewick | Washington |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Kinston Medical Specialists | Kinston | North Carolina |
United States | Center for Cancer Care and Research at Watson Clinic, LLP | Lakeland | Florida |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Southwest Medical Center | Liberal | Kansas |
United States | Liberty Hospital | Liberty | Missouri |
United States | St. Rita's Medical Center | Lima | Ohio |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | McDonough District Hospital | Macomb | Illinois |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois |
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 | Community Medical Center | Missoula | Montana |
United States | Guardian Oncology and Center for Wellness | Missoula | Montana |
United States | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana |
United States | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana |
United States | Good Samaritan Regional Health Center | Mt. Vernon | Illinois |
United States | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah |
United States | Mercy General Health Partners | Muskegon | Michigan |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Medical Center of Louisiana - New Orleans | New Orleans | Louisiana |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | BroMenn Regional Medical Center | Normal | Illinois |
United States | Community Cancer Center | Normal | Illinois |
United States | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah |
United States | Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington |
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 | Community Hospital of Ottawa | Ottawa | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois |
United States | OSF St. Francis Medical Center | Peoria | Illinois |
United States | Proctor Hospital | Peoria | Illinois |
United States | Illinois Valley Community Hospital | Peru | Illinois |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Perry Memorial Hospital | Princeton | Illinois |
United States | Utah Valley Regional Medical Center - Provo | Provo | Utah |
United States | Good Samaritan Cancer Center | Puyallup | Washington |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | Dixie Regional Medical Center - East Campus | Saint George | Utah |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri |
United States | David C. Pratt Cancer Center at St. John's Mercy | Saint Louis | Missouri |
United States | Midwest Hematology Oncology Group, Incorporated | Saint Louis | Missouri |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
United States | LDS Hospital | Salt Lake City | Utah |
United States | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah |
United States | Cancer Therapy and Research Center | San Antonio | Texas |
United States | University Hospital - San Antonio | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | California Pacific Medical Center - California Campus | San Francisco | California |
United States | New Mexico Cancer Care Associates | Santa Fe | New Mexico |
United States | Guthrie Cancer Center at Guthrie Clinic Sayre | Sayre | Pennsylvania |
United States | Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton | Pennsylvania |
United States | Mercy Hospital Cancer Center - Scranton | Scranton | Pennsylvania |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Harborview Medical Center | Seattle | Washington |
United States | Polyclinic First Hill | Seattle | Washington |
United States | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
United States | Shawnee Mission Medical Center | Shawnee Mission | Kansas |
United States | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
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 | Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Cancer Care Northwest - Spokane South | Spokane | Washington |
United States | St. Margaret's Hospital | Spring Valley | Illinois |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Mercy Medical Center | Springfield | Ohio |
United States | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois |
United States | Allenmore Hospital | Tacoma | Washington |
United States | CCOP - Northwest | Tacoma | Washington |
United States | Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington |
United States | Madigan Army Medical Center - Tacoma | Tacoma | Washington |
United States | MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington |
United States | St. Clare Hospital | Tacoma | Washington |
United States | Cotton-O'Neil Cancer Center | Topeka | Kansas |
United States | Munson Medical Center | Traverse City | Michigan |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Sutter Solano Medical Center | Vallejo | California |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
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 | Clinton Memorial Hospital | Wilmington | Ohio |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Metro Health Hospital | Wyoming | Michigan |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States, Canada, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year Disease-free Survival (DFS) | Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse. | After completing any treatment, every 6 months for 2 years, than annually for years 3-5 | No |
Primary | Complete Remission | After induction therapy was completed (1 or 2 months) | No | |
Secondary | Toxicity | Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event | For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O. | Yes |
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