ClinicalTrials.gov record
Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT00651261
Public ClinicalTrials.gov record NCT00651261. 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 Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
Study identification
- NCT ID
- NCT00651261
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 717 participants
Conditions and interventions
Conditions
Interventions
- cytarabine Drug
- daunorubicin Drug
- midostaurin Drug
- placebo Other
- dexamethasone acetate Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 59 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
- Apr 2008 (Actual)
- Primary completion
- Jul 2016 (Actual)
- Completion
- Mar 28, 2022 (Actual)
- Last update posted
- Oct 21, 2026
2008 – 2022
United States locations
- U.S. sites
- 170
- U.S. states
- 37
- U.S. cities
- 129
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| University of California Davis Cancer Center | Sacramento | California | 95817 | — |
| Aurora Presbyterian Hospital | Aurora | Colorado | 80012 | — |
| Boulder Community Hospital | Boulder | Colorado | 80301-9019 | — |
| 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 | — |
| 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 | 80501 | — |
| McKee Medical Center | Loveland | Colorado | 80539 | — |
| North Suburban Medical Center | Thornton | Colorado | 80229 | — |
| Exempla Lutheran Medical Center | Wheat Ridge | Colorado | 80033 | — |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford | Connecticut | 06102-5037 | — |
| Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | 19958 | — |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | — |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | — |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | 32207 | — |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | 32803-1273 | — |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa | Florida | 33612-9497 | — |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | — |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur | Georgia | 30033 | — |
| Medical Center of Central Georgia | Macon | Georgia | 31208 | — |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405 | — |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | — |
| Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Illinois CancerCare - Bloomington | Bloomington | Illinois | 61701 | — |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | — |
| University of Illinois Cancer Center | Chicago | Illinois | 60612-7243 | — |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | — |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | — |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | — |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | — |
| McFarland Clinic, PC | Ames | Iowa | 50010 | — |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | — |
| 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 | — |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | — |
| Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | 71315-3198 | — |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport | Louisiana | 71130-3932 | — |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield | Massachusetts | 01199 | — |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | — |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | — |
| 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 | — |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | — |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan | 48075 | — |
| Munson Medical Center | Traverse City | Michigan | 49684 | — |
| Metro Health Hospital | Wyoming | Michigan | 49519 | — |
| 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 | — |
| 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 | — |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| 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 | — |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | — |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | — |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | — |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | — |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | — |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| 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 | — |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York | 10940-4199 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | — |
| 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 | — |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | — |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | — |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27834 | — |
| 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 | — |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | — |
| 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 | — |
| Cleo Craig Cancer Research Clinic | Lawton | Oklahoma | 73505 | — |
| Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | 73104 | — |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | — |
| Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | 18201 | — |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224-1791 | — |
| 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 | — |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Cancer Centers of the Carolinas - Easley | Easley | South Carolina | 29640 | — |
| Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | 29605 | — |
| Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | 29605 | — |
| Greenville Hospital Cancer Center | Greenville | South Carolina | 29605 | — |
| CCOP - Greenville | Greenville | South Carolina | 29615 | — |
| Self Regional Cancer Center at Self Regional Medical Center | Greenwood | South Carolina | 29646 | — |
| Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | 29650 | — |
| Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | 29672 | — |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | 29307 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | — |
| University of Tennessee Cancer Institute - Memphis | Memphis | Tennessee | 38104 | — |
| Tennessee Oncology, PLLC at Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | — |
| Baylor University Medical Center - Houston | Houston | Texas | 77030 | — |
| Ben Taub General Hospital | Houston | Texas | 77030 | — |
| Veterans Affairs Medical Center - Houston | Houston | Texas | 77030 | — |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | — |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | — |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | — |
| West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | 25304 | — |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | 26506 | — |
| Marshfield Clinic - Chippewa Center | Chippewa Falls | Wisconsin | 54729 | — |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin | 54701 | — |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | 54701 | — |
| 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 | — |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | — |
| 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 | — |
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | — |
| Saint Joseph's Hospital | Marshfield | Wisconsin | 54449 | — |
| Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | 54548 | — |
| D.N. Greenwald Center | Mukwonago | Wisconsin | 53149 | — |
| Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | — |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | 54501 | — |
| Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | 54868 | — |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin | 54481 | — |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | 53188 | — |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | — |
| Ministry Saint Clare's Hospital | Weston | Wisconsin | 54476 | — |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00651261, 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 21, 2026 · Synced Oct 29, 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 NCT00651261 live on ClinicalTrials.gov.