ClinicalTrials.gov record
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT00492856
Public ClinicalTrials.gov record NCT00492856. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
S0521, A Randomized Trial of Maintenance Versus Observation for Patients With Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Study identification
- NCT ID
- NCT00492856
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 120 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
- Jun 1, 2007 (Type not available)
- Primary completion
- Dec 1, 2013 (Actual)
- Completion
- May 4, 2016 (Actual)
- Last update posted
- Jan 10, 2023
2007 – 2016
United States locations
- U.S. sites
- 210
- U.S. states
- 28
- U.S. cities
- 138
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Sutter Cancer Center at Roseville Medical Center | Roseville | California | 95661 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| Stanford Cancer Center | Stanford | California | 94305-5824 | — |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Hematology Oncology Associates of Illinois - Berwyn | Berwyn | Illinois | 60402 | — |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | — |
| St. Joseph Medical Center | Bloomington | Illinois | 61701 | — |
| Graham Hospital | Canton | Illinois | 61520 | — |
| Illinois CancerCare - Canton | Canton | Illinois | 61520 | — |
| Illinois CancerCare - Carthage | Carthage | Illinois | 62321 | — |
| Memorial Hospital | Carthage | Illinois | 62321 | — |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | — |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | — |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | — |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | — |
| Eureka Community Hospital | Eureka | Illinois | 61530 | — |
| Illinois CancerCare - Eureka | Eureka | Illinois | 61530 | — |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | — |
| Illinois CancerCare - Havana | Havana | Illinois | 62644 | — |
| Mason District Hospital | Havana | Illinois | 62644 | — |
| Kellogg Cancer Care Center | Highland Park | Illinois | 60035 | — |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | — |
| Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | 61443 | — |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | — |
| Illinois CancerCare - Macomb | Macomb | Illinois | 61455 | — |
| McDonough District Hospital | Macomb | Illinois | 61455 | — |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Illinois CancerCare - Monmouth | Monmouth | Illinois | 61462 | — |
| La Grange Oncology Associates - Geneva | Naperville | Illinois | 60563 | — |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | 60714 | — |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Community Cancer Center | Normal | Illinois | 61761 | — |
| Illinois CancerCare - 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 | — |
| Illinois CancerCare - Pekin | Pekin | Illinois | 61603 | — |
| 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 CancerCare - Peru | Peru | Illinois | 61354 | — |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | — |
| Illinois CancerCare - Princeton | Princeton | Illinois | 61356 | — |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | — |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | — |
| Illinois CancerCare - Spring Valley | Spring Valley | Illinois | 61362 | — |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010 | — |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | — |
| 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 - Fort Scott | Fort Scott | Kansas | 66701 | — |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | — |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67905 | — |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | — |
| 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 | 67401 | — |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | — |
| 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 | — |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | — |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | — |
| Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | 21921 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| St. John Macomb Hospital | Warren | Michigan | 48093 | — |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | — |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | — |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | — |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | — |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | — |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | — |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | — |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | — |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | — |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | — |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | — |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | — |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | — |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | — |
| 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 | — |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | — |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | — |
| 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 | — |
| 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 | — |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse | New York | 13057 | — |
| Monter Cancer Center of the North Shore-LIJ Health System | Lake Success | New York | 11042 | — |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | — |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | — |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | 10466 | — |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | — |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | — |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | — |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | — |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | — |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | — |
| Barberton Citizens Hospital | Barberton | Ohio | 44203 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | — |
| St. Rita's Medical Center | Lima | Ohio | 45801 | — |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | — |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | — |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | — |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | — |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | — |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | — |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| 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 | — |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | — |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | — |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | — |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98273 | — |
| Harrison Poulsbo Hematology and Onocology | Poulsbo | Washington | 98370 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| 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 | — |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | — |
| Evergreen Hematology and Oncology, PS | Spokane | Washington | 99218 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | — |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | 26506 | — |
| 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 | — |
| Holy Family Memorial Medical Center Cancer Care Center | Manitowoc | Wisconsin | 54221-1450 | — |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | — |
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | — |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00492856, 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 Jan 10, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00492856 live on ClinicalTrials.gov.