Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
Public ClinicalTrials.gov record NCT01757535. 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 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.
Study identification
- NCT ID
- NCT01757535
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 472 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 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
- Apr 24, 2013 (Actual)
- Primary completion
- Jul 15, 2019 (Actual)
- Completion
- Jun 18, 2024 (Actual)
- Last update posted
- Jul 8, 2025
2013 – 2024
United States locations
- U.S. sites
- 60
- U.S. states
- 28
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, P.C. | Phoenix | Arizona | 85016 | — |
| Providence St Joseph Medical Center Cancer Center | Burbank | California | 91505 | — |
| City Of Hope | Duarte | California | 91010-301 | — |
| University of California San Francisco Fresno Campus | Fresno | California | 93701 | — |
| University of Southern California Norris Cancer Center | Los Angeles | California | 90033 | — |
| Local Institution - 006 | Los Angeles | California | 90095-6956 | — |
| Local Institution - 050 | Orange | California | 92868 | — |
| Sharp Memorial Hospital | San Diego | California | 92123 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218-1210 | — |
| Local Institution - 010 | Southington | Connecticut | 06489 | — |
| George Washington University Cancer Center | Washington D.C. | District of Columbia | 20037 | — |
| Local Institution - 046 | Gainesville | Florida | 32610 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Local Institution - 044 | Orlando | Florida | 32806 | — |
| Northwestern University Medical Center | Chicago | Illinois | 60611 | — |
| Loyola University Chicago | Maywood | Illinois | 60153 | — |
| Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL | Niles | Illinois | 60714 | — |
| Local Institution - 013 | Indianapolis | Indiana | 46202-528 | — |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | — |
| Local Institution - 003 | Westwood | Kansas | 66205 | — |
| Local Institution - 049 | Louisville | Kentucky | 40202 | — |
| Local Institution - 058 | Louisville | Kentucky | 40207 | — |
| Local Institution - 047 | New Orleans | Louisiana | 70112 | — |
| Ochsner Medical Center - Jefferson Highway | New Orleans | Louisiana | 70121-2483 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Local Institution - 015 | Worcester | Massachusetts | 01655 | — |
| Local Institution - 037 | Rochester | Minnesota | 55905 | — |
| Local Institution - 023 | Kansas City | Missouri | 64128 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | — |
| Local Institution - 057 | Omaha | Nebraska | 68198-7680 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Winthrop University Hospital | Mineola | New York | 11501-3893 | — |
| Local Institution - 009 | New York | New York | 10029 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Local Institution - 002 | New York | New York | 10065 | — |
| Local Institution - 004 | Rochester | New York | 14642 | — |
| Local Institution - 014 | Valhalla | New York | 10595 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Local Institution - 025 | Winston-Salem | North Carolina | 27157 | — |
| Local Institution - 016 | Cleveland | Ohio | 44106 | — |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Kaiser Permanente Northwest Oncology Hematology | Portland | Oregon | 97227 | — |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | — |
| UPMC Cancer Pavillion | Pittsburgh | Pennsylvania | 15232 | — |
| Greenville Hospital System | Greenville | South Carolina | 29605 | — |
| Local Institution - 011 | Nashville | Tennessee | 37203 | — |
| Local Institution - 007 | Nashville | Tennessee | 37232-5505 | — |
| Local Institution - 041 | Dallas | Texas | 75390-9068 | — |
| Local Institution - 034 | Fort Sam Houston | Texas | 78234 | — |
| Local Institution - 001 | Houston | Texas | 77030 | — |
| Cancer Care Centers of South Texas - Loop | San Antonio | Texas | 78217 | — |
| Local Institution - 039 | San Antonio | Texas | 78229 | — |
| Local Institution - 035 | Richmond | Virginia | 23298-0037 | — |
| Swedish Cancer Inst | Seattle | Washington | 98104 | — |
| Yakima Valley Memorial Hospital/ North Star Lodge | Yakima | Washington | 98902 | — |
| Froedtert Hospital BMT Medical College of Wisconsin | Milwaukee | Wisconsin | 53226-3522 | — |
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 163 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01757535, 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 8, 2025 · 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 NCT01757535 live on ClinicalTrials.gov.