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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT01566695

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:28 AM EDT

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Evaluation of 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) lower risk myelodysplastic syndromes (MDS).

Study identification

NCT ID
NCT01566695
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celgene
Industry
Enrollment
216 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
Apr 26, 2013 (Actual)
Primary completion
Jan 25, 2019 (Actual)
Completion
Dec 21, 2023 (Actual)
Last update posted
Jan 7, 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 7, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01566695 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →