Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study
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Official title
Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.
Study identification
- NCT ID
- NCT00715637
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 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
- Jun 2007 (Type not available)
- Primary completion
- Jun 2010 (Estimated)
- Completion
- Not listed
- Last update posted
- Oct 13, 2010
Started 2007
United States locations
- U.S. sites
- 30
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angelas | California | 90095 | — |
| Univ of Southern California Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | — |
| Rocky Mountain Blood and Marrow Transplant Program | Denver | Colorado | 80218 | — |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | — |
| The Blood and Marrow Transplant Group of GA | Atlanta | Georgia | 30342 | — |
| Northwestern University School of Medicine | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Iowa Hospitals | Iowa City | Iowa | 52242 | — |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| LSU Health Sciences Center, Feist-Weiller Cancer Center | Shreveport | Louisiana | 71103 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02114 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Michigan State University | Lansing | Michigan | 48910 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Northshore Hospital - Monter Cancer Center | Lake Success | New York | 11042 | — |
| Duke University Medical Center | Durham | North Carolina | 27707 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Taussig Cancer Center, Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17036 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | — |
| Roger Williams Medical Center | Providence | Rhode Island | 02908 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Cancer Center of the Carolinas | Greenville | South Carolina | 29605 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Intermountain Healthcare | Salt Lake City | Utah | 84103 | — |
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 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00715637, 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 13, 2010 · Synced Nov 13, 2026
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