ClinicalTrials.gov record
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT00557193
Public ClinicalTrials.gov record NCT00557193. 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 Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
Study identification
- NCT ID
- NCT00557193
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 218 participants
Conditions and interventions
Conditions
Interventions
- Asparaginase Drug
- Biospecimen Collection Procedure
- Bone Marrow Biopsy Procedure
- Cyclophosphamide Drug
- Cytarabine Drug
- Daunorubicin Hydrochloride Drug
- Dexamethasone Drug
- Echocardiography Procedure
- Etoposide Drug
- Filgrastim Biological
- Laboratory Biomarker Analysis Other
- Lestaurtinib Drug
- Leucovorin Calcium Drug
- Mercaptopurine Drug
- Methotrexate Drug
- Methylprednisolone Drug
- Multigated Acquisition Scan Procedure
- Pegaspargase Drug
- Pharmacological Study Other
- Prednisone Drug
- Therapeutic Hydrocortisone Drug
- Vincristine Sulfate Drug
Drug · Procedure · Biological + 1 more
Eligibility (public fields only)
- Age range
- Up to 1 Year
- 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
- Jan 15, 2008 (Actual)
- Primary completion
- Sep 30, 2017 (Actual)
- Completion
- Jun 30, 2024 (Actual)
- Last update posted
- Jul 15, 2024
2008 – 2024
United States locations
- U.S. sites
- 157
- U.S. states
- 47
- U.S. cities
- 123
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Lee Memorial Health System | Fort Myers | Florida | 33901 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | — |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | — |
| Saint Mary's Hospital | West Palm Beach | Florida | 33407 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | — |
| Saint Luke's Cancer Institute - Boise | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | — |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana | 46260 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Michigan State University Clinical Center | East Lansing | Michigan | 48824 | — |
| Hurley Medical Center | Flint | Michigan | 48503 | — |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Columbia Regional | Columbia | Missouri | 65201 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | 89135 | — |
| Summerlin Hospital Medical Center | Las Vegas | Nevada | 89144 | — |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89169 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| Overlook Hospital | Summit | New Jersey | 07902 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | — |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | — |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | — |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | — |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | — |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | — |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | 79106 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | — |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | — |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00557193, 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 Jul 15, 2024 · Synced Oct 17, 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 NCT00557193 live on ClinicalTrials.gov.