ClinicalTrials.gov record
Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT00658814
Public ClinicalTrials.gov record NCT00658814. 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 II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, 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. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.
Study identification
- NCT ID
- NCT00658814
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 133 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia
- Adult Acute Megakaryoblastic Leukemia
- Adult Acute Monoblastic Leukemia
- Adult Acute Monocytic Leukemia
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With Maturation
- Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22.1); RUNX1-RUNX1T1
- Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A
- Adult Acute Myeloid Leukemia Without Maturation
- Adult Acute Myelomonocytic Leukemia
- Adult Erythroleukemia
- Adult Pure Erythroid Leukemia
- Secondary Acute Myeloid Leukemia
Eligibility (public fields only)
- Age range
- 60 Years and older
- 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 1, 2008 (Actual)
- Primary completion
- Jun 1, 2013 (Actual)
- Completion
- Mar 31, 2027 (Estimated)
- Last update posted
- Oct 22, 2026
2008 – 2027
United States locations
- U.S. sites
- 177
- U.S. states
- 21
- U.S. cities
- 125
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | — |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | — |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | — |
| OSF Saint Anthony's Health Center | Alton | Illinois | 62002 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| Heartland Cancer Research NCORP | Decatur | Illinois | 62526 | — |
| Advocate Sherman Hospital | Elgin | Illinois | 60123 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| SSM Health Good Samaritan | Mount Vernon | Illinois | 62864 | — |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | — |
| Franciscan Saint Francis Health-Beech Grove | Beech Grove | Indiana | 46107 | — |
| Reid Health | Richmond | Indiana | 47374 | — |
| Hospital District Sixth of Harper County | Anthony | Kansas | 67003 | — |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | — |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | — |
| Cancer Center of Kansas - 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-Kingman | Kingman | Kansas | 67068 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| Southwest Medical Center | Liberal | Kansas | 67901 | — |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | — |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | — |
| Menorah Medical Center | Overland Park | Kansas | 66209 | — |
| Saint Luke's South Hospital | Overland Park | Kansas | 66213 | — |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | — |
| Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas | 66208 | — |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | — |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | — |
| Salina Regional Health Center | Salina | Kansas | 67401 | — |
| AdventHealth Shawnee Mission | Shawnee Mission | Kansas | 66204 | — |
| Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | 66606 | — |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | — |
| Associates In Womens Health | Wichita | Kansas | 67208 | — |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | — |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | — |
| Wesley Medical Center | Wichita | Kansas | 67214 | — |
| Wichita NCI Community Oncology Research Program | Wichita | Kansas | 67214 | — |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana | 70809 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | 48106 | — |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | — |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | — |
| Spectrum Health Big Rapids Hospital | Big Rapids | Michigan | 49307 | — |
| Corewell Health Dearborn Hospital | Dearborn | Michigan | 48124 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Health Saint John Hospital | Detroit | Michigan | 48236 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Genesys Regional Medical Center-West Flint Campus | Flint | Michigan | 48532 | — |
| Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | 49503 | — |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | — |
| Allegiance Health | Jackson | Michigan | 49201 | — |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | — |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | — |
| Trinity Health Muskegon Hospital | Muskegon | Michigan | 49444 | — |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | — |
| Lake Huron Medical Center | Port Huron | Michigan | 48060 | — |
| MyMichigan Medical Center Saginaw | Saginaw | Michigan | 48601 | — |
| Henry Ford Health Providence Southfield Hospital | Southfield | Michigan | 48075 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| Henry Ford Health Warren Hospital | Warren | Michigan | 48093 | — |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Southeast Missouri Hospital | Cape Girardeau | Missouri | 63701 | — |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | — |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Saint Joseph Health Center | Kansas City | Missouri | 64114 | — |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | — |
| Heartland Hematology and 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 | — |
| Liberty Hospital | Liberty | Missouri | 64068 | — |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | — |
| Mercy Infusion Center - Chippewa | St Louis | Missouri | 63109 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Saint Louis-Cape Girardeau CCOP | St Louis | Missouri | 63141 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | — |
| Saint Vincent Healthcare | Billings | Montana | 59101 | — |
| Montana Cancer Consortium NCORP | Billings | Montana | 59102 | — |
| Saint Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Saint James Community Hospital and Cancer Treatment Center | Butte | Montana | 59701 | — |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Berdeaux, Donald MD (UIA Investigator) | Great Falls | Montana | 59405 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Northern Montana Hospital | Havre | Montana | 59501 | — |
| Saint Peter's Community Hospital | Helena | Montana | 59601 | — |
| Glacier Oncology PLLC | Kalispell | Montana | 59901 | — |
| Kalispell Medical Oncology | Kalispell | Montana | 59901 | — |
| Logan Health Medical Center | Kalispell | Montana | 59901 | — |
| Montana Cancer Specialists | Missoula | Montana | 59802 | — |
| Saint Patrick Hospital - Community Hospital | Missoula | Montana | 59802 | — |
| Community Medical Center | Missoula | Montana | 59804 | — |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | — |
| Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | — |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | — |
| Southeast Clinical Oncology Research Consortium NCORP | Winston-Salem | North Carolina | 27104 | — |
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | — |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | — |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | — |
| University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio | 45219 | — |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Columbus NCI Community Oncology Research Program | Columbus | Ohio | 43215 | — |
| Grant Medical Center | Columbus | Ohio | 43215 | — |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | — |
| Doctors Hospital | Columbus | Ohio | 43228 | — |
| Grandview Hospital | Dayton | Ohio | 45405 | — |
| Good Samaritan Hospital - Dayton | Dayton | Ohio | 45406 | — |
| Miami Valley Hospital | Dayton | Ohio | 45409 | — |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | — |
| Dayton NCI Community Oncology Research Program | Dayton | Ohio | 45459 | — |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | — |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | — |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | — |
| Wayne Hospital | Greenville | Ohio | 45331 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | — |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | — |
| Knox Community Hospital | Mount Vernon | Ohio | 43050 | — |
| Licking Memorial Hospital | Newark | Ohio | 43055 | — |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | — |
| Springfield Regional Medical Center | Springfield | Ohio | 45504 | — |
| Upper Valley Medical Center | Troy | Ohio | 45373 | — |
| Saint Ann's Hospital | Westerville | Ohio | 43081 | — |
| Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center | Wilmington | Ohio | 45177 | — |
| Greene Memorial Hospital | Xenia | Ohio | 45385 | — |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | — |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | — |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | — |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | — |
| Providence Newberg Medical Center | Newberg | Oregon | 97132 | — |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | — |
| Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | 97210 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Adventist Medical Center | Portland | Oregon | 97216 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | — |
| Salem Hospital | Salem | Oregon | 97301 | — |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | — |
| AnMed Health Hospital | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| The Don and Sybil Harrington Cancer Center | Amarillo | Texas | 79106 | — |
| Cancer Care Center at Island Hospital | Anacortes | Washington | 98221 | — |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Saint Anne Hospital | Burien | Washington | 98166 | — |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | — |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | — |
| Skagit Valley Hospital | Mount Vernon | Washington | 98274 | — |
| Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington | 98370 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| Minor and James Medical PLLC | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| Kaiser Permanente Washington | Seattle | Washington | 98112 | — |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122 | — |
| University of Washington Medical Center - Montlake | Seattle | Washington | 98195 | — |
| PeaceHealth United General Medical Center | Sedro-Woolley | Washington | 98284 | — |
| Saint Joseph Medical Center Hematology and Oncology - Silverdale | Silverdale | Washington | 98383 | — |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | — |
| Evergreen Hematology and Oncology PS | Spokane | Washington | 99218 | — |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | — |
| Wenatchee Valley Hospital and Clinics | Wenatchee | Washington | 98801 | — |
| Rocky Mountain Oncology | Casper | Wyoming | 82609 | — |
| Welch Cancer Center | 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 NCT00658814, 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 Oct 22, 2026 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00658814 live on ClinicalTrials.gov.