Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
Conditions
Leukemia, Myeloid, Acute
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Maintenance therapy, AML, Acute Myeloid Leukemia, oral Azacitidine, best supportive care, complete remission
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: 300 mg Oral Azacitidine Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
Summary
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 (AML), age = or >55 years, who have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction with intensive chemotherapy with or without consolidation chemotherapy.
Detailed Description
This is an international, multicenter, placebo-controlled, phase 3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplastic Syndromes (MDS).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 55 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Male or female subjects ≥ 55 years of age

2. Newly diagnosed, confirmed de novo AML or AML Secondary to prior MDS

3. First CR/CRi with induction therapy ± consolidation therapy within 90 days of achieving CR

4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

Exclusion Criteria:

1. AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations

2. Prior bone marrow or stem cell transplantation

3. Candidate for allogeneic bone marrow or stem cell transplant

4. Have achieved CR/CRi following therapy with hypomethylating agents

5. Diagnosis of malignant disease within the previous 12 months

6. Proven Central Nervous System (CNS) leukemia
Locations
Arizona Oncology Associates
Phoenix, Arizona, United States
Status: Recruiting
Providence St Joseph Medical Center/Cancer Center
Burbank, California, United States
Status: Withdrawn
University of California San Francisco Fresno Campus
Fresno, California, United States
Status: Recruiting
UCLA
Los Angeles, California, United States
Status: Recruiting
Sharp Memorial Hospital
San Diego, California, United States
Status: Recruiting
Stanford Cancer Center
Stanford, California, United States
Status: Recruiting
Innovative Clinical Research Institute, LLC
Whittier, California, United States
Status: Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Status: Recruiting
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Status: Recruiting
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, United States
Status: Not yet recruiting
Northwestern University Medical Center Division of Hematology/Oncology
Chicago, Illinois, United States
Status: Withdrawn
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
Niles, Illinois, United States
Status: Recruiting
Indiana University Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Kansas University Medical Center
Westwood, Kansas, United States
Status: Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Status: Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Status: Recruiting
University of Massachusetts
Worcester, Massachusetts, United States
Status: Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, United States
Status: Recruiting
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Withdrawn
John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Status: Withdrawn
Winthrop University Hospital
Mineola, New York, United States
Status: Recruiting
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Mt. Sinai Medical Center
New York, New York, United States
Status: Recruiting
New York Presbyterian Hospital - Weill-Cornell
New York, New York, United States
Status: Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Status: Recruiting
New York Medical College
Valhalla, New York, United States
Status: Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Status: Withdrawn
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Seidman Clinical Trials
Cleveland, Ohio, United States
Status: Recruiting
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Status: Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Status: Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Status: Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Status: Recruiting
Methodist Hospital
Houston, Texas, United States
Status: Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Cancer Care Center of South Texas
San Antonio, Texas, United States
Status: Recruiting
VA Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Status: Recruiting
Swedish Cancer Inst
Seattle, Washington, United States
Status: Recruiting
Yakima Valley Memorial Hospital / North Star Lodge
Yakima, Washington, United States
Status: Recruiting
Froedtert Hospital/BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Liverpool Hospital
Liverpool, New South Wales, Australia
Status: Recruiting
Royal North Shore Hospital
St Léonards, New South Wales, Australia
Status: Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Status: Recruiting
Princess Alexandra Hospital
Woollongabba, Queensland, Australia
Status: Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Status: Recruiting
Royal Hobart Hospital
Hobart, Tasmania, Australia
Status: Recruiting
Austin Hospital
Heidelberg, Victoria, Australia
Status: Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Status: Recruiting
Royal Perth Hospital
Perth, Western Australia, Australia
Status: Recruiting
Medical University of Graz
Graz, Australia
Status: Recruiting
The Queen Elizabeth Hospital
Woodville South, Australia
Status: Recruiting
Medical University of Graz
Graz, Austria
Status: Recruiting
University Hospital of Salzburg
Salzburg, Austria
Status: Withdrawn
KH Hietzing
Vienna, Austria
Status: Not yet recruiting
Medical University of Vienna
Vienna, Austria
Status: Recruiting
Hanusch Krankenhaus
Wien, Austria
Status: Recruiting
Grand Hopital de Charleroi asbl
Charleroi, Hainaut, Belgium
Status: Recruiting
AZ Sint-Jan AV Brugge
Brugge, Belgium
Status: Recruiting
Center Hospitalier Universitaire Ambroise Paré
Mons, Belgium
Status: Recruiting
Hospital Erasto Gaertner
Curitiba, Brazil
Status: Not yet recruiting
Hospital Israelita Albert Einstein
Morumbi, Brazil
Status: Not yet recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Status: Not yet recruiting
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil
Status: Not yet recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanês
Sao Paulo, Brazil
Status: Not yet recruiting
University of Alberta
Edmonton, Alberta, Canada
Status: Recruiting
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Status: Recruiting
Regional Health Authority B-Saint John Hospital
Saint John, New Brunswick, Canada
Status: Recruiting
Health Sciences Center
St. John's, Newfoundland and Labrador, Canada
Status: Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Status: Recruiting
Princess Margaret Hospital
Toronto, Ontario, Canada
Status: Recruiting
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Status: Recruiting
McGill University, Dept. OncologyClinical Research Program
Montreal, Quebec, Canada
Status: Recruiting
Fakultni nemocnice Brno
Brno, Czech Republic
Status: Recruiting
Ustav hematologie a krevni transfuze
Praha, Czech Republic
Status: Recruiting
Vseobecna fakultni nemocnice v Praze
Praha, Czech Republic
Status: Recruiting
Meilahden kolmiosairaala
Helsinki, Etela-Suomen Iaani, Finland
Status: Recruiting
University HospitaClinik of internal medicin
Tampere, Finland
Status: Recruiting
Turku University Hospital
Turku, Finland
Status: Recruiting
Hopital Sud, CHU d'Amiens
Amiens, France
Status: Not yet recruiting
Hôpital Avicenne
Bobigny Cedex, France
Status: Not yet recruiting
Hôpital Henri Mondor
Creteil, France
Status: Not yet recruiting
CHRU de Lille -Hôpital Claude Huriez Service des Maladies du Sang
Lille, France
Status: Not yet recruiting
CHU Hôpital Edouard Herriot
Lyon Cedex, France
Status: Not yet recruiting
Hôpital Saint Louis
Paris, France
Status: Not yet recruiting
Centre Henri Becquerel
Rouen, France
Status: Not yet recruiting
Institut Gustave Roussy
Villejuif Cedex, France
Status: Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Status: Recruiting
Universitaetsklinikum Bonn
Bonn, Germany
Status: Recruiting
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Status: Recruiting
University Düsseldorf
Düsseldorf, Germany
Status: Recruiting
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main, Germany
Status: Recruiting
Wilhelm-Anton-Hospital Goch gGmbH Hämatologie und Internistische Onkologie
Goch, Germany
Status: Recruiting
Medizinische Hochschule Hannover
Hannover, Germany
Status: Recruiting
Klinikum am Gesundbrunnen
Heilbronn, Germany
Status: Recruiting
Universitätsklinikum Jena
Jena, Germany
Status: Recruiting
UK Schleswig-Holstein im Städtischen Krankenhaus Kiel
Kiel, Germany
Status: Recruiting
Universitaetsklinikum Mannheim
Mannheim, Germany
Status: Recruiting
Staedtisches Klinikum Muenchen Schwabing
Muenchen, Germany
Status: Recruiting
TU München - Klinikum rechts der Isar
München, Germany
Status: Recruiting
Klinikum Oldenburg gGmbH
Oldenburg, Germany
Status: Recruiting
University of Ulm
Ulm, Germany
Status: Recruiting
Tallaght Adelaide and Meath Hospital
Dublin, Ireland
Status: Recruiting
University College Hospital Galway
Galway, Ireland
Status: Recruiting
Soroka University Medical Center
Be'er Sheva, HaDarom, Israel
Status: Recruiting
Hadassah University Hospital Ein Kerem
Jerusalem, Yerushalayim, Israel
Status: Recruiting
Rambam Medical Center
Haifa, Israel
Status: Recruiting
Rabin Medical Center
Petach Tikva, Israel
Status: Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, BA, Italy
Status: Recruiting
Ospedale S. Gerardo di Monza
Monza, Lombardia, Italy
Status: Recruiting
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
Orbassano, Torino, Italy
Status: Recruiting
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria, Italy
Status: Recruiting
Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Status: Recruiting
Ospedale Bingaghi
Cagliari, Italy
Status: Recruiting
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, Italy
Status: Recruiting
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy
Status: Recruiting
IRCCS AziendaOspedaliera Universitaria San Martino
Genova, Italy
Status: Recruiting
Presidio Ospedaliero Vito Fazzi
Lecce, Italy
Status: Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano, Italy
Status: Recruiting
Azienda ospedeliera della 2 Università di Napoli
Naples, Italy
Status: Recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Status: Recruiting
Azienda Ospedaliera Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Status: Recruiting
Universita degli Studi di Roma La Sapienza
Roma, Italy
Status: Recruiting
University Hospital Tor Vergata
Rome, Italy
Status: Not yet recruiting
Osp. S.Giovanni Battista Le Molinette
Torino, Italy
Status: Recruiting
University Turin
Torino, Italy
Status: Recruiting
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine, Italy
Status: Recruiting
Ospedale di Circolo di Varese
Varese, Italy
Status: Recruiting
Kyungpook National University Hospital
Daegu, Korea, Republic of
Status: Recruiting
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
The Catholic University of Korea Seoul
Seoul, Korea, Republic of
Status: Recruiting
Klaipeda seaman hospital
Klaipeda, Lithuania
Status: Recruiting
Hospital Angeles Lomas City
Huixquilucan de Degollado, Mexico
Status: Recruiting
Instituto Nacional de Cancerología
Mexico City, Mexico
Status: Not yet recruiting
Hospital Universitario Eleuterio Gomez
Monterrey, Mexico
Status: Recruiting
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz, Poland
Status: Not yet recruiting
Institute of Internal Diseases University of Medicine
Gdansk, Poland
Status: Recruiting
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland
Status: Recruiting
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
Status: Recruiting
Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, Poland
Status: Recruiting
Centro Hospitalar e Universitario de Coimbra, EPE
Coimbra, Portugal
Status: Recruiting
Centro Hospitalar de Lisboa central - Hospital de Santo António dos Capuchos
Lisboa, Portugal
Status: Recruiting
Instituto Português de Oncologia de Lisboa
Lisboa, Portugal
Status: Recruiting
Hospital de Sao Joao
Porto, Portugal
Status: Recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil
Porto, Portugal
Status: Recruiting
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow, Russian Federation
Status: Recruiting
Nizhniy Novgorod State Medical Academy of Roszdrav
Nizhniy Novgorod, Russian Federation
Status: Recruiting
Saint Petersburg Medical State Institution Municipal n.a. I.P. Pavlov
Saint Petersburg, Russian Federation
Status: Recruiting
Hospital Universitario Reina Sofia
Cordoba, Andalucia, Spain
Status: Recruiting
Hospital Virgen del Rocio
Sevilla, Andalucia, Spain
Status: Recruiting
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain
Status: Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Cataluna, Spain
Status: Recruiting
Hospital Vall D'Hebron
Barcelona, Cataluna, Spain
Status: Recruiting
Hospital Universitario a Coruna
La Coruna, Galicia, Spain
Status: Recruiting
Hospital Clinico San Carlos
Madrid, Madrid, Comunidad de, Spain
Status: Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Valenciana, Spain
Status: Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Status: Recruiting
Hospital Universitario Gregorio Marañón
Madrid, Spain
Status: Recruiting
Hospital Universitario La Princesa
Madrid, Spain
Status: Recruiting
Hospital Universitario de Salamanca
Salamanca, Spain
Status: Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital
Ankara, Turkey
Status: Not yet recruiting
Hacettepe Üniversitesi
Ankara, Turkey
Status: Not yet recruiting
Marmara School of Medicine
Itanbul, Turkey
Status: Not yet recruiting
Ondokuz Mayis University Medical Faculty
Samsun, Turkey
Status: Not yet recruiting
Royal Sussex County Hospital
Brighton East Sussex, East Sussex, United Kingdom
Status: Recruiting
Royal Free Hospital
London, Hampstead, United Kingdom
Status: Recruiting
Kent and Canterbury Hospital
Canterbury Kent, United Kingdom
Status: Recruiting
Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust
Essex, United Kingdom
Status: Recruiting
Kings College Hospital
London, United Kingdom
Status: Recruiting
Christie NHS Trust Hospital
Manchester, United Kingdom
Status: Recruiting
Nottingham City Hospital
Nottingham, United Kingdom
Status: Recruiting
Start Date
April 2013
Completion Date
August 2018
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page