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Completed Phase 3 Interventional Results available

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

ClinicalTrials.gov ID: NCT01757535

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.

ClinicalTrials.gov public records Last synced May 21, 2026, 2:23 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, 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

Study identification

NCT ID
NCT01757535
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Celgene
Industry
Enrollment
472 participants

Conditions and interventions

Interventions

  • Oral Azacitidine Drug
  • Placebo Drug

Drug

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 23, 2013
Primary completion
Jul 14, 2019
Completion
Jun 17, 2024
Last update posted
Jul 7, 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 7, 2025 · Synced May 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01757535 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →