A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT01303796. 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 Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Study identification
- NCT ID
- NCT01303796
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 482 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 70 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
- Oct 1, 2011 (Actual)
- Primary completion
- Dec 15, 2016 (Actual)
- Completion
- Jul 31, 2017 (Actual)
- Last update posted
- Jun 22, 2022
2011 – 2017
United States locations
- U.S. sites
- 39
- U.S. states
- 25
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| Scripps Cancer Center | La Jolla | California | 92037 | — |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06850 | — |
| Shands Cancer Hospital at University of Florida | Gainesville | Florida | 32608 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | — |
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| St. Francis Medical Group Oncology and Hematology Specialists | Indianapolis | Indiana | 46237 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Maryland Greenbaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| St. Louis University Cancer Center | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| John Theurer Cancer Center at the Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Westchester Hematology Oncology Group, PC | Hawthorne | New York | 10532 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Saint Francis Hospital | Greenville | South Carolina | 29601 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030-3387 | — |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | — |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 | — |
| The Medical College 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 79 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01303796, 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 Jun 22, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01303796 live on ClinicalTrials.gov.