The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)
Public ClinicalTrials.gov record NCT01566695. 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, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Subjects With Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes.
Study identification
- NCT ID
- NCT01566695
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Celgene
- Industry
- Enrollment
- 216 participants
Conditions and interventions
Conditions
Interventions
- Oral Azacitidine Drug
- Placebo Drug
- Best Supportiv Care (BSC) Other
Drug · Other
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
- Apr 25, 2013
- Primary completion
- Jan 24, 2019
- Completion
- Dec 20, 2023
- Last update posted
- Jan 6, 2025
2013 – 2023
United States locations
- U.S. sites
- 40
- U.S. states
- 23
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alta Bates Comprehensive Cancer Center | Berkeley | California | 94704 | — |
| Tower Hematology/Oncology Medical Group and Tower Cancer Research Found | Beverly Hills | California | 90211 | — |
| City Of Hope | Duarte | California | 91010-301 | — |
| California Cancer Associates for Research and Excellence cCARE | Escondido | California | 92025 | — |
| Marin Oncology Associates | Greenbrae | California | 94904-2007 | — |
| UCSD-Thornton Hospital | La Jolla | California | 92093-0943 | — |
| University of Southern California Norris Cancer Center | Los Angeles | California | 90033 | — |
| Local Institution - 942 | New Haven | Connecticut | 06519 | — |
| University of Florida Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Phoebe Cancer Center of Phoebe Putney Memorial Hospital | Albany | Georgia | 31701 | — |
| Robert H Lurie Comprehensive Cancer Center NW Univ | Chicago | Illinois | 60611 | — |
| University Of Illinois At Chicago | Chicago | Illinois | 60612 | — |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Loyola University Chicago | Maywood | Illinois | 60153 | — |
| University Of Kansas Medical Center | Kansas City | Kansas | 66160-7233 | — |
| University of Louisville, J.G. Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Hematology And Oncology Specialists, Llc | Metairie | Louisiana | 70006 | — |
| Johns Hopkins Medicine | Baltimore | Maryland | 21231 | — |
| UMASS Memorial Hospital | Worcester | Massachusetts | 01655 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Jackson Oncology Associates PLLC | Jackson | Mississippi | 39202 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | — |
| Kansas City VA Medical Center University of Kansas Medical Center | Kansas City | Missouri | 64128 | — |
| University Of Nebraska Medical Center | Omaha | Nebraska | 68198-6805 | — |
| Weill Cornell Medical College - New York - Presbyterian Hospital | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai Medical Center | New York | New York | 10029 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Eastern Institute of Medical Sciences | Greenville | North Carolina | 27834 | — |
| University Hospitals of Cleveland Case Medical Center | Cleveland | Ohio | 44106-5000 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Local Institution - 917 | Portland | Oregon | 97227 | — |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | — |
| Brooke Army Medical Center Francis Street Medical Center | Fort Sam Houston | Texas | 78235-8200 | — |
| Local Institution - 900 | Houston | Texas | 77030 | — |
| Local Institution - 924 | Houston | Texas | 77030 | — |
| Millennium Physicians - Oncology | Houston | Texas | 77090 | — |
| VA Commonwealth University - Massey Cancer Center | Richmond | Virginia | 23298-0037 | — |
| Local Institution - 904 | Seattle | Washington | 98109-4417 | — |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188-5099 | — |
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 156 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01566695, 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 6, 2025 · Synced Jul 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 protocol, eligibility criteria, and contact information for NCT01566695 live on ClinicalTrials.gov.