ClinicalTrials.gov record
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
ClinicalTrials.gov ID: NCT00551460
Public ClinicalTrials.gov record NCT00551460. 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
S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia
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 find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
Study identification
- NCT ID
- NCT00551460
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Interventions
- arsenic trioxide Drug
- gemtuzumab ozogamicin Drug
- mercaptopurine Drug
- methotrexate Drug
- tretinoin Drug
Drug
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
- Nov 15, 2007 (Actual)
- Primary completion
- Jun 1, 2017 (Actual)
- Completion
- Feb 5, 2018 (Actual)
- Last update posted
- Jan 10, 2023
2007 – 2018
United States locations
- U.S. sites
- 192
- U.S. states
- 28
- U.S. cities
- 142
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sutter Cancer Center at Roseville Medical Center | Roseville | California | 95661 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| Stanford Cancer Center | Stanford | California | 94305-5824 | — |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | — |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | — |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | — |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| 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 | — |
| Kellogg Cancer Care Center | Highland Park | Illinois | 60035 | — |
| Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee | Illinois | 60901 | — |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | — |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | 60714 | — |
| Swedish-American Regional Cancer Center | Rockford | Illinois | 61104-2315 | — |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | — |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | — |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51102 | — |
| 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 | — |
| Providence Medical Center | Kansas City | Kansas | 66112 | — |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | 67901 | — |
| Cancer Center of Kansas, PA - McPherson | McPherson | Kansas | 67460 | — |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | — |
| Menorah Medical Center | Overland Park | Kansas | 66209 | — |
| Saint Luke's Hospital - South | Overland Park | Kansas | 66213 | — |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | — |
| CCOP - Kansas City | Prairie Village | Kansas | 66208 | — |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas, PA - Salina | 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 | — |
| 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 of Cecil County | Elkton | Maryland | 21921 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | — |
| 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 | — |
| Dickinson County Healthcare System | Iron Mountain | Michigan | 49801 | — |
| 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 | 49444 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341-2985 | — |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | — |
| Spectrum Health Reed City Hospital | Reed City | Michigan | 49677 | — |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| 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 | — |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | — |
| CCOP - Duluth | Duluth | Minnesota | 55805 | — |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | — |
| 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 - Maplewood | Maplewood | Minnesota | 55109 | — |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | — |
| New Ulm Medical Center | New Ulm | Minnesota | 56073 | — |
| 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 | — |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | 56201 | — |
| Minnesota Oncology - Woodbury | Woodbury | Minnesota | 55125 | — |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | — |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | — |
| Heartland Hematology Oncology Associates, Incorporated | Kansas City | Missouri | 64118 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | — |
| Parvin Radiation Oncology | Liberty | Missouri | 64068 | — |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | — |
| Saint Joseph Oncology, Incorporated | Saint Joseph | Missouri | 64507 | — |
| Saint Louis University Cancer Center | St Louis | Missouri | 63110 | — |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | — |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | — |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59102 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | — |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | — |
| 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 | — |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | — |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | — |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | — |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | — |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | — |
| 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 | — |
| 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 | — |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | — |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | — |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | — |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | — |
| American Fork Hospital | American Fork | Utah | 84003 | — |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | — |
| Logan Regional Hospital | Logan | Utah | 84321 | — |
| 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 | — |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | — |
| LDS Hospital | Salt Lake City | Utah | 84143 | — |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | — |
| Island Hospital Cancer Care Center at Island Hospital | Anacortes | Washington | 98221 | — |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | — |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | — |
| Highline Medical Center Cancer Center | Burien | Washington | 98166 | — |
| Swedish Medical Center - Issaquah Campus | Issaquah | Washington | 98029 | — |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | — |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98274 | — |
| 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 | — |
| North Puget Oncology at United General Hospital | Sedro-Woolley | Washington | 98284 | — |
| 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 | — |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | — |
| St. Nicholas Hospital | Sheboygan | Wisconsin | 53081 | — |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | — |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | — |
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 NCT00551460, 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 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00551460 live on ClinicalTrials.gov.