Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT00416598. 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
Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.
Study identification
- NCT ID
- NCT00416598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 546 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia With Myelodysplasia-Related Changes
- Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- 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)(p22.3;q23.3); MLLT3-KMT2A
- Untreated Adult Acute Myeloid Leukemia
Interventions
- Autologous Bone Marrow Transplantation Procedure
- Autologous Hematopoietic Stem Cell Transplantation Procedure
- Busulfan Drug
- Cytarabine Drug
- Daunorubicin Hydrochloride Drug
- Decitabine Drug
- Etoposide Drug
- Filgrastim Biological
- Laboratory Biomarker Analysis Other
- Pharmacological Study Other
Procedure · Drug · Biological + 1 more
Eligibility (public fields only)
- Age range
- 15 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
- Nov 15, 2006 (Actual)
- Primary completion
- Jan 31, 2011 (Actual)
- Completion
- Dec 1, 2016 (Actual)
- Last update posted
- Feb 19, 2019
2006 – 2016
United States locations
- U.S. sites
- 46
- U.S. states
- 22
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | — |
| Beebe Medical Center | Lewes | Delaware | 19958 | — |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | — |
| Florida Hospital Orlando | Orlando | Florida | 32803 | — |
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| Fort Wayne Medical Oncology and Hematology Inc-Parkview | Fort Wayne | Indiana | 46845 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | — |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | — |
| Union Hospital of Cecil County | Elkton | Maryland | 21921 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Commonwealth Hematology Oncology PC-Worcester | Worcester | Massachusetts | 01605 | — |
| Veterans Administration | Columbia | Missouri | 65201 | — |
| University of Missouri - Ellis Fischel | Columbia | Missouri | 65212 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Great Plains Health Callahan Cancer Center | North Platte | Nebraska | 69101 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada | 89106 | — |
| Sunrise Hospital and Medical Center | Las Vegas | Nevada | 89109 | — |
| Cheshire Medical Center-Dartmouth-Hitchcock Keene | Keene | New Hampshire | 03431 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Cooper Hospital University Medical Center | Camden | New Jersey | 08103 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Northwell Health NCORP | Lake Success | New York | 11042 | — |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners | Vermont | 05602 | — |
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | — |
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 NCT00416598, 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 Feb 19, 2019 · Synced Oct 21, 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 NCT00416598 live on ClinicalTrials.gov.