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Trial record 1 of 1 for:    CC-486-AML-001
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Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission (QUAZAR AML-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01757535
Recruitment Status : Active, not recruiting
First Posted : December 31, 2012
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de novo AML (Acute Myeloid Leukemia) 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. Subjects who have previously achieved CR/CRi with a hypomethylating agent will be excluded from the study.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: 300 mg Oral Azacitidine Drug: Placebo Phase 3

Detailed Description:
This is an international, multicenter, placebo-controlled, phase3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplasic Syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 24, 2013
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : April 30, 2019


Arm Intervention/treatment
Experimental: Oral Azacitidine
300mg Oral Azacitidine for the first 14 days of each 28 days treatment cycle
Drug: 300 mg Oral Azacitidine
Maintenance therapy

Placebo Comparator: Placebo
300 mg Placebo for the first 14 days of each 28 days treatment cycle
Drug: Placebo



Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 60 months ]
    Number of participants who survive


Secondary Outcome Measures :
  1. Relapse free survival (RFS) [ Time Frame: 60 months ]
    Number of participants who survive without relapsing

  2. Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi) [ Time Frame: 60 months ]
    Time to relapse from Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi). Time to relapse from CR/CRi is defined as the interval from the date of randomization to the date of documented relapse after CR or CRi, as defined according to the IWG AML response criteria.

  3. Safety and Tolerability [ Time Frame: 60 months ]
    Number of participants with adverse events

  4. Healthcare Resource Utilization [ Time Frame: 60 months ]
    Effect of oral azacitidine compared with Placebo on healthcare utilization. Healthcare utilization data will be collected as described below: Information on each hospitalization will be collected utilizing a CRF designed specifically for this purpose. Information to be collected will include, but not be limited to, the reason for hospitalization (eg, disease relapse, AML-related illness, treatment-related AE), and days of hospitalization by treatment setting (inpatient, special care unit). Other disease- and treatment-related forms of healthcare utilization will be collected through routine study activities. These include diagnostic procedures and treatment interventions not requiring hospitalization such as those required for AML-related illness, or for treatment-related adverse events. Additionally, information on all concomitant medications and resource use associated with treatment administration for AML will be collected. Healthcare resource utilization information will be

  5. Patient-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D [ Time Frame: 60 months ]
    FACT-F Functional Assessment of Cancer Therapy-Fatigue, EuroQol-5D (EQ-5D) measure of health outcome and 3 additional exploratory questions



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects ≥ 55 years of age
  2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
  3. First Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
  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. Have achieved CR/CRi following therapy with hypomethylating agents
  4. Diagnosis of malignant disease within the previous 12 months
  5. Proven Central Nervous System (CNS) leukemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757535


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Locations
United States, Arizona
Arizona Oncology Associates, P.C.
Phoenix, Arizona, United States, 85016
United States, California
Providence St Joseph Medical Center Cancer Center
Burbank, California, United States, 91505
City of Hope
Duarte, California, United States, 91010-301
University of California San Francisco Fresno Campus
Fresno, California, United States, 93701
University of Southern California Norris Cancer Center
Los Angeles, California, United States, 90033
UCLA
Los Angeles, California, United States, 90095-6956
UC Irvine
Orange, California, United States, 92868
Sharp Memorial Hospital
San Diego, California, United States, 92123
Stanford Cancer Center
Stanford, California, United States, 94305-582
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218-1210
United States, Connecticut
The Hospital of Central Connecticut
Southington, Connecticut, United States, 06489
United States, District of Columbia
George Washington University Cancer Center
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Illinois
Northwestern University Medical Center Division of Hematology Oncology
Chicago, Illinois, United States, 60611
Loyola University Chicago
Maywood, Illinois, United States, 60153
Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL
Niles, Illinois, United States, 60714
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-528
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Kansas
Kansas University Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Norton Cancer Institute Louisville Oncology
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121-2483
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City, Missouri, United States, 64128
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501-3893
Mt. Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Weill Cornell Medical College
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
UPMC Cancer Pavillion
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Sarah Cannon Research Inst
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5505
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9068
Brooke-Army Medical Center
Fort Sam Houston, Texas, United States, 78234
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas - Loop
San Antonio, Texas, United States, 78217
Methodist Hospital
San Antonio, Texas, United States, 78229
United States, Virginia
VA Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Swedish Cancer Inst
Seattle, Washington, United States, 98104
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, United States, 98902
United States, Wisconsin
Froedtert Hospital BMT Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-3522
Australia, Queensland
Mater Private Medical Centre Haematology and Oncology Clinics of Australasia Research Centre
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, SA 5000
Flinders Medical Centre, Dept Of Oncology
Bedford Park, South Australia, Australia, 5042
Australia
Austin Hospital
Heidelberg, Australia, 3084
Royal Hobart Hospital
Hobart, Australia, 7000
Liverpool Hospital
Liverpool, Australia, 2170
The Alfred Hospital
Melbourne, Australia, 3004
Royal Perth Hospital
Perth, Australia, 6000
Royal North Shore Hospital
St Leonards, Australia, 2065
Wollongong Hospital
Wollongong, Australia, 2500
The Queen Elizabeth Hospital
Woodville South, Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Austria
Medical University of Graz
Graz, Austria, A-8036
University Hospital of Salzburg
Salzburg, Austria, 5020
KH Hietzing
Vienna, Austria, 1130
Medical University of Vienna
Vienna, Austria, 1190
Hanusch Krankenhaus
Wien, Austria, 1140
Belgium
AZ St-Jan Brugge Oostende AV
Brugge, Belgium, 8000
Grand Hopital de Charleroi
Charleroi, Belgium, 6000
Center Hospitalier Universitaire Ambroise Pare
Mons, Belgium, 7000
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Brazil, 20230-130
Saint Petersburg Medical State Institution Municipal n.a. I.P. Pavlov
Saint Petersburg, Brazil, 196022
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
Sao Paulo, Brazil, 05651-901
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, Brazil, 01308-050
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E OV9
Canada, New Brunswick
Regional Health Authority B-Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Health Sciences Center
St John's, Newfoundland and Labrador, Canada, A1B3V6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University, Dept. Oncology Clinical Research Program
Montreal, Quebec, Canada, H2W 1S6
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Vseobecna Fakultni Nemocnice v Praze
Praha, Czechia, 128 08
Ustav hematologie a krevni transfuze
Praha, Czechia, 128 20
Finland
Helsinki University Central Hospital
Helsinki, Finland, 290
University HospitaClinik of internal medicin
Tampere, Finland, 33521
Turku University Hospital
Turku, Finland, 20521
France
Hopital Sud, CHU d'Amiens
Amiens, France, 80054
CH Argenteuil Victor Dupouy
Argenteuil, France, 95100
Hopital Avicenne
Bobigny Cedex, France, 93009
Centre hospitalier de Boulognes - Duchenne
Boulognes Sur Mer, France, 62200
Hopital dinstruction des armees Percy
Clamart Cedex, France, 92141
Hopital Henri Mondor
Creteil, France, 94010
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay Cedex, France, 78157
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille, France, 59037
CHU Limoges
Limoges Cedex, France, 87042
CHU Hopital Edouard Herriot
Lyon cedex, France, 69437
Hopital Saint Louis
Paris Cedex 10, France, 75475
Hospital of Necker
Paris, France, 75015
Hopital Saint Louis
Paris, France, 75475
Centre Hospitalier Pontoise Rene Dubos
Pontoise, France, 95301
Centre Henri Becquerel
Rouen, France, 76038
Institut Curie
Saint-Cloud, France, 92210
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Germany
Charite - Universitätsmedizin Berlin
Berlin, Germany, 12203
Universitaetsklinikum Bonn
Bonn, Germany, 53127
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
University Duesseldorf
Düsseldorf, Germany, 40225
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Staedtische Kliniken Frankfurt am Main Hochst
Frankfurt am Main, Germany, 65929
Wilhelm-Anton-Hospital Goch gGmbH Hämatologie und Internistische Onkologie
Goch, Germany, 47574
Medizinische Hochschule Hannover
Hannover, Germany, 30625
SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, Germany, 74078
Universitatsklinikum Jena
Jena, Germany, 07740
Universitatsklinikum Schleswig-Holstein
Keil, Germany, 24105
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Staedtisches Klinikum Muenchen Schwabing
Muenchen, Germany, 80804
TU München - Klinikum rechts der Isar
München, Germany, 81675
Klinikum Oldenburg gGmbH
Oldenburg, Germany, 26133
St. Antonius-Hospital
Schweiler, Germany, 52249
University of Ulm
Ulm, Germany, 89081
Ireland
Tallaght Adelaide and Meath Hospital
Dublin, Ireland, 24
University College Hospital Galway
Galway, Ireland, ST46QG
Israel
Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 35254
Hadassah Medical Center
Jerusalem, Israel, 91120
Rabin Medical Center
Petach Tikva, Israel, 49100
Italy
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria, Italy, 15121
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Ospedale Bingaghi
Cagliari, Italy, O9126
Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50129
IRCCS AziendaOspedaliera Universitaria San Martino
Genova, Italy, 16132
Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
Lecce, Italy, 73100
ASST Grande Ospedale Metropolitano Niguarda, Milano
Milano, Italy, 20162
Fondazione Ca Granda IRCCS Ospedale Maggiore
Milan, Italy, 20122
Ospedale S. Gerardo di Monza
Monza, Italy, 20900
Azienda ospedeliera della 2 Universita di Napoli
Naples, Italy, 80131
Ospedale Cardarelli
Naples, Italy, 80131
AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy, 90146
Casa di Cura La Maddalena, Divisione di Ematologia
Palermo, Italy, 90146
Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN
Pesaro, Italy, 31122
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy, 89100
Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I
Roma, Italy, 00161
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Azienda Ospedaliera S. Andrea - Università La Sapienza
Roma, Italy, 00189
University Hospital Tor Vergata
Rome, Italy, 133
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
Udine, Italy, 33100
A.O. Universitaria Fondazione Macchi
Varese, Italy, 21100
Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
The Catholic University of Korea Seoul - Saint Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Lithuania
Klaipeda seaman hospital
Klaipeda, Lithuania, 5809
Mexico
Hospital Angeles Lomas - Consultorio 830
Huixquilucan de Degollado, Mexico, 52763
Instituto Nacional de Cancerología
Mexico, Mexico, 14080
Hospital Universitario Eleuterio Gomez
Monterrey, Mexico, 64460
Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz, Poland, 85-168
Institute of Internal Diseases University of Medicine
Gdansk, Poland, 80-211
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Institute of Hematology and Transfusion Medicine
Warsaw, Poland, 02-776
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Poland, 50-367
Portugal
Centro Hospital e Universitario de Coimbra
Coimbra, Portugal, 4200-072
Instituto Portugues de Oncologia de Lisboa
Lisboa, Portugal, 1099-023
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa, Portugal, 1150-314
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto, Portugal, 4200-072
Hospital de Sao Joao
Porto, Portugal, 4200
Russian Federation
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin
Moscow, Russian Federation, 125101
Nizhniy Novgorod State Medical Academy of Roszdrav
Nizhniy Novgorod, Russian Federation, 603005
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St Petersburg, Russian Federation, 197341
Spain
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), Spain, 8916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 8035
Hospital de San Pedro de Alcantara
Caceres, Spain, 10003
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Complejo Universitario La Coruna
La Coruna, Spain, 15006
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Clinico Universitario San Carlos
Madrid, Spain, 28040
Hospital Central de Asturias
Oviedo, Spain, 33006
Hospital Son Llatzer
Palma de Mallorca, Spain, 7198
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Taiwan
Taipei Veterans General Hospital
Beitou District, Taipei City, Taiwan, 11217
Kaohsiung Chang Gung Memorial Hospital
Niaosong District Kaohsiung City, Taiwan, 83301
China Medical University Hospital
Taichung, Northern Dist., Taiwan, 404
National Cheng Kung University Hospital
Tainan, Taiana, Taiwan, 704
National Taiwan University Hospital
Taipei, Zhongzheng Dist., Taiwan, 100
Turkey
Hacettepe Universitesi
Ankara, Turkey, 06100
Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital
Ankara, Turkey, 06200
Marmara School of Medicine
Istanbul, Turkey, 34662
Ondokuz Mayis University Medical Faculty
Samsun, Turkey, 55139
United Kingdom
United Lincolnshire Hospitals NHS Trust
Boston, United Kingdom, PE21 9QS
Royal Sussex County Hospital
Brighton East Sussex, United Kingdom, BN2 5BE
Kent and Canterbury Hospital
Canterbury Kent, United Kingdom, CT1 3NG
University College London Hospitals
London, United Kingdom, NW1 2PG
Kings College Hospital
London, United Kingdom, SE5 9RS
Imperial College Hammersmith Hospital
London, United Kingdom, W12 0HS
Maidstone Hospital
Maidstone Kent, United Kingdom, ME16 9QQ
Christie NHS Trust Hospital
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, Essex, United Kingdom, RM7 0AG
Sponsors and Collaborators
Celgene
Investigators
Study Director: Ignazia La Torre, MD Celgene Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01757535     History of Changes
Other Study ID Numbers: CC-486-AML-001
2012-003457-28 ( EudraCT Number )
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Celgene:
Maintenance therapy
AML
Acute Myeloid Leukemia
oral Azacitidine
best supportive care
complete remission

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors