Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
Public ClinicalTrials.gov record NCT00049517. 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
A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.
Study identification
- NCT ID
- NCT00049517
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 657 participants
Conditions and interventions
Conditions
Interventions
- sargramostim Biological
- busulfan Drug
- cyclophosphamide Drug
- cytarabine Drug
- gemtuzumab ozogamicin (GO) Drug
- Daunorubicin Drug
- Autologous HCT Procedure
- Allogeneic HCT Procedure
Biological · Drug · Procedure
Eligibility (public fields only)
- Age range
- 16 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 19, 2002 (Actual)
- Primary completion
- Mar 2009 (Actual)
- Completion
- Dec 2019 (Actual)
- Last update posted
- Jun 15, 2023
2002 – 2019
United States locations
- U.S. sites
- 98
- U.S. states
- 19
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham | Alabama | 35294 | — |
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | — |
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | — |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs | Colorado | 80933 | — |
| St. Anthony Central Hospital | Denver | Colorado | 80204 | — |
| Porter Adventist Hospital | Denver | Colorado | 80210 | — |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | — |
| St. Joseph Hospital | Denver | Colorado | 80218 | — |
| Rose Medical Center | Denver | Colorado | 80220 | — |
| CCOP - Colorado Cancer Research Program | Denver | Colorado | 80224-2522 | — |
| Swedish Medical Center | Englewood | Colorado | 80110 | — |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction | Colorado | 81502 | — |
| North Colorado Medical Center | Greeley | Colorado | 80631 | — |
| Sky Ridge Medical Center | Lone Tree | Colorado | 80124 | — |
| Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | 80502 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | 81004 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West | Boca Raton | Florida | 33428 | — |
| Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton | Florida | 33486 | — |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | — |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | — |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | — |
| Evanston Northwestern Healthcare - Evanston Hospital | Evanston | Illinois | 60201-1781 | — |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | — |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | — |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | — |
| La Grange Oncology Associates - Geneva | Naperville | Illinois | 60563 | — |
| Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | 60714 | — |
| Advocate Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068-1174 | — |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | — |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | — |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46815 | — |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | — |
| Tufts-NEMC Cancer Center | Boston | Massachusetts | 02111 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| MeritCare Bemidji | Bemidji | Minnesota | 56601 | — |
| 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 | — |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | — |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| 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 | — |
| United Hospital | Saint Paul | Minnesota | 55102 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | — |
| 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 | — |
| Great Falls Clinic | 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 | — |
| 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 | — |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | — |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | — |
| MeritCare Broadway | Fargo | North Dakota | 58122 | — |
| Mercy Cancer Center at Mercy Medical Center | Canton | Ohio | 44708 | — |
| Aultman Cancer Center at Aultman Hospital | Canton | Ohio | 44710-1799 | — |
| Jewish Hospital Cancer Center | Cincinnati | Ohio | 45236 | — |
| St. Rita's Medical Center | Lima | Ohio | 45801 | — |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | — |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | — |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | — |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | — |
| 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 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | — |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | — |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | — |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | — |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | — |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | — |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | — |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00049517, 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 Jun 15, 2023 · Synced Oct 16, 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 NCT00049517 live on ClinicalTrials.gov.