ClinicalTrials.gov record
Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT00369317
Public ClinicalTrials.gov record NCT00369317. 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
The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase III trial is studying how well combination chemotherapy works in treating young patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes. 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. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Study identification
- NCT ID
- NCT00369317
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 205 participants
Conditions and interventions
Conditions
- Childhood Acute Basophilic Leukemia
- Childhood Acute Eosinophilic Leukemia
- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia With Maturation (M2)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myelomonocytic Leukemia (M4)
- Childhood Myelodysplastic Syndromes
- de Novo Myelodysplastic Syndromes
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
Interventions
- asparaginase Drug
- daunorubicin hydrochloride Drug
- cytarabine Drug
- thioguanine Drug
- etoposide Drug
- laboratory biomarker analysis Other
Drug · Other
Eligibility (public fields only)
- Age range
- Up to 4 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
- Mar 2007 (Type not available)
- Primary completion
- Dec 1, 2013 (Actual)
- Completion
- Dec 31, 2021 (Actual)
- Last update posted
- Jan 28, 2022
2007 – 2021
United States locations
- U.S. sites
- 88
- U.S. states
- 38
- U.S. cities
- 76
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Southern California Permanente Medical Group | Downey | California | 90242 | — |
| Miller Children's Hospital | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Central California | Madera | California | 93636-8762 | — |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609-1809 | — |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | — |
| Childrens Hospital of Orange County | Orange | California | 92868-3874 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | — |
| University of California San Francisco Medical Center-Parnassus | San Francisco | California | 94143 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Lombardi Comprehensive Cancer Center at Georgetown University | Washington D.C. | District of Columbia | 20057 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207-8426 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | — |
| University of Hawaii | Honolulu | Hawaii | 96813 | — |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | — |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60614 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Advocate Lutheran General Hospital. | Park Ridge | Illinois | 60068 | — |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61602 | — |
| Southern Illinois University | Springfield | Illinois | 62702 | — |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Saint Vincent Hospital and Health Services | Indianapolis | Indiana | 46260 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | — |
| Johns Hopkins University-Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Wayne State University-Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Saint John Hospital and Medical Center | Detroit | Michigan | 48236 | — |
| Hurley Medical Center | Flint | Michigan | 48502 | — |
| Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| The Childrens Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| UMDNJ - Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| Ny Cancer% | Valhalla | New York | 10595 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Sanford Medical Center-Fargo | Fargo | North Dakota | 58122 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Penn State Hershey 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 | — |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Vermont | Burlington | Vermont | 05401 | — |
| Childrens Hospital-King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | 98405 | — |
| Midwest Children's Cancer Center | 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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00369317, 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 28, 2022 · Synced Oct 20, 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 NCT00369317 live on ClinicalTrials.gov.