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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01566695
First received: March 27, 2012
Last updated: April 24, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: Oral Azacitidine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Red blood cell (RBC) transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Red blood cell (RBC) transfusion independence


Secondary Outcome Measures:
  • Number of patients alive [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]
    Number of patients alive

  • Hematological improvement-platelet response (HI-P) [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Hematological improvement-platelet response (HI-P)

  • Duration of RBC transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Duration of RBC transfusion independence

  • Time to RBC transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Time to RBC transfusion independence

  • Progression to acute myeloid leukemia (AML) [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Progression to acute myeloid leukemia (AML)

  • Time to AML progression [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Time to AML progression

  • Hematological improvement-erythroid response (HI-E) [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Hematological improvement-erythroid response (HI-E)

  • Platelet-transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Platelet-transfusion independence

  • Duration of platelet transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Duration of platelet transfusion independence

  • Time to platelet transfusion independence [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Time to platelet transfusion independence

  • Hematologic response [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Hematologic response

  • Clinically significant bleeding events [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]
    Clinically significant bleeding events

  • Number of subjects with adverse events [ Time Frame: Up to 60 months ] [ Designated as safety issue: Yes ]
    Number of subjects with adverse events

  • Health-related quality-of-life [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Health-related quality-of-life

  • Healthcare resource utilization [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Healthcare resource utilization


Estimated Enrollment: 386
Study Start Date: April 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral Azacitidine
Arm 1: Oral azacitidine 300mg daily + best supportive care (First 21 days of each 28-day cycle)
Drug: Oral Azacitidine
300mg daily, First 21 days of each 28-day cycle
Placebo Comparator: Placebo
Arm 2: Placebo plus best supportive care (First 21 days of each 28-day cycle)
Drug: Placebo
Placebo, First 21 days of each 28-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Have a documented diagnosis of MDS
  • Anemia that requires red blood cell transfusions
  • Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Must agree to follow pregnancy precautions as required by protocol.
  • Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study.

Exclusion Criteria:

  • Secondary or hypoplastic MDS or other subtype with eligibility for treatment with immunotherapy
  • Prior treatment with azacitidine, decitabine, other hypomethylating agents and lenalidomide
  • Prior allogeneic or autologous stem cell transplant
  • Eligible for allogenic or autologous stem cell transplant
  • History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
  • Thrombocytopenia secondary to other possible causes, including medication(s), congenital disorder(s), immune disorder(s), or microvascular disorder(s)
  • Use of cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, thrombopoiesis-stimulating agents (TSAs), erythropoiesis-stimulating agents (ESAs) and other red blood cell hematopoietic growth factors, and within 28 days prior to randomization
  • Ongoing medically significant adverse events from previous treatment, regardless of the time period
  • Concurrent use of iron-chelating agents, (except for subjects on a stable or decreasing dose for at least 8 weeks (56 days) prior to randomization), corticosteroid (except for subjects on a stable or decreasing dose for ≥ 1 week prior to randomization for medical conditions other than MDS)
  • Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system is allowed)
  • Significant active cardiac disease within the previous 6 months
  • Uncontrolled systemic fungal, bacterial, or viral infection
  • Known Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
  • Abnormal coagulation parameters
  • Abnormal liver function test results
  • Abnormal kidney function test results
  • Known or suspected hypersensitivity to azacitidine or mannitol
  • Any significant medical condition, laboratory abnormality, or psychiatric illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566695

Contacts
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 ClinicalTrialDisclosure@celgene.com

  Hide Study Locations
Locations
United States, California
Alta Bates Comprehensive Cancer Center Recruiting
Berkeley, California, United States, 94704
Tower Hematology/Oncology Medical Group and Tower Cancer Research Found Completed
Beverly Hills, California, United States, 90211
California Cancer Associates for Research and Excellence (cCARE) Recruiting
Escondido, California, United States, 92025
Marin Oncology Associates Recruiting
Greenbrae, California, United States, 94904-2007
UCSD-Thornton Hospital Recruiting
La Jolla, California, United States, 92093-0943
United States, Georgia
Phoebe Cancer Center of Phoebe Putney Memorial Hospital Recruiting
Albany, Georgia, United States, 31701
United States, Illinois
Robert H Lurie Comprehensive Cancer Center/ NW Univ Active, not recruiting
Chicago, Illinois, United States, 60611
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Medical Center Completed
Kansas City, Kansas, United States, 66160-7233
United States, Louisiana
Hematology and Oncology Specialists, LLC Recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
UMASS Memorial Hospital Recruiting
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
United States, Mississippi
Jackson Oncology Associates PLLC Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Luke's Cancer Institute Recruiting
Kansas City, Missouri, United States, 64111
Kansas City VA Medical Center/University of Kansas Medical Center Recruiting
Kansas City, Missouri, United States, 64128
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
United States, New York
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Weill Cornell Medical College - New York - Presbyterian Hospital Recruiting
New York, New York, United States, 10021
United States, North Carolina
Levine Cancer Institute Completed
Charlotte, North Carolina, United States, 28204
Eastern Institute of Medical Sciences Completed
Greenville, North Carolina, United States, 27834
United States, Ohio
University Hospitals of Cleveland Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106-5000
Ohio State University Medical Center Completed
Columbus, Ohio, United States, 43210
United States, Oregon
Kaiser Permanente Northwest Oncology/Hematology Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Cancer Institute Completed
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Brooke Army Medical Center Francis Street Medical Center Recruiting
Ft. Sam Houston, Texas, United States, 78235-8200
MD Anderson Cancer Center The University of Texas Recruiting
Houston, Texas, United States, 77030
Michael Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Millenium Oncology Recruiting
Houston, Texas, United States, 77090
United States, Virginia
VA Commonwealth University Massey Cancer Center Completed
Richmond, Virginia, United States, 23298-0037
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-4417
Australia, Victoria
Monash Medical Centere, Clayton Campus Recruiting
Clayton, Victoria, Australia, 3168
Frankston Hospital Oncology Research Recruiting
Frankston, Victoria, Australia, 3199
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia, SA 5000
Box Hill Hospital and Eastern Clinical Research Unit Withdrawn
Box Hill, Australia, 3128
Royal Prince Alfred Hospital, Sydney Cancer Centre Recruiting
Camperdown, Australia, 2050
The Northern Hospital Recruiting
Epping, VIC, Australia, 3076
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Australia, 3065
St George Hospital Recruiting
Kogarah, Australia, 2217
Cabrini Hospital Recruiting
Malvern, Australia, 3144
Haematoloy and Oncology Clinics of Australia Recruiting
Milton, Brisbane, Australia, 4064
Princess Alexandra Hospital Recruiting
Woolloongabba, Australia, QLD 4102
Belgium
AZ Klina Recruiting
Brasschaat, Belgium, 2930
AZ St-Jan Brugge Oostende AV Recruiting
Brugge, Belgium, 8000
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium, 6000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Hospital Israelita Albert Einstein Not yet recruiting
Morumbi, Brazil, 05651-901
Canada, Alberta
University of Alberta Hospital (Adult Hematology Research) Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University, Dept. Oncology Clinical Research Program Not yet recruiting
Montreal, Quebec, Canada, H2W 1S6
Hopital du Sacre-Coeur de Montreal Recruiting
Montreal, Quebec, Canada, H4J 1C5
Czech Republic
Fakultni nemocnice Brno Recruiting
Brno, Czech Republic, 625 00
University Hospital Hradec Kralove Recruiting
Hradec Králové, Czech Republic, 500 05
University Hospital Olomouc Recruiting
Olomouc, Czech Republic, 77520
Ustav hematologie a krevni transfuze Recruiting
Praha, Czech Republic, 128 20
Vseobecna Fakultni Nemocnice v Praze Recruiting
Praha, Czech Republic, 128 08
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Onk.Dep., Odense Universitets hospital Recruiting
Odense C, Denmark, 5000
Roskilde Hospital Recruiting
Roskilde, Denmark, DK-4000
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029 HUS
Turku University Hospital Recruiting
Turku, Finland, 20521
France
CHRU de Lille -Hôpital Claude Huriez Service des Maladies du Sang Recruiting
Lille, France, 59037
Institute Paoli-Calmettes Service Haematology Recruiting
Marseille Cedex 9, France, 13009
CHU Nantes Hôtel Dieu Recruiting
Nantes, France, 44093
Hospital Saint Louis Recruiting
Paris, France, 7575
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite Cedex, France, 69495
CHRU Hôpital de Pontchaillou Recruiting
Rennes Cedex, France, 35033
Centre Henri Becquerel Recruiting
Rouen Cedex, France, 76038
Hôpital Civil de Strasbourg Recruiting
Strasbourg, France, 67091
CHU Purpan Recruiting
Toulouse, France, 31059
Hopital Bretonneau Recruiting
Tours, France, 37044
Germany
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Gemeinschaftspraxis Haematologie-Onkologie Recruiting
Dresden, Germany, 01307
Marien Hospital Recruiting
Duesseldorf, Germany, 40479
Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie Recruiting
Dusseldorf, Germany, 40225
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, D-20099
UK Schleswig-Holstein im Städtischen Krankenhaus Kiel Recruiting
Kiel, Germany, 24116
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
TU München - Klinikum rechts der Isar Recruiting
München, Germany, 81675
University-Hospital Tübingen Recruiting
Tubingen, Germany, 72076
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Italy
Az. Osp. SS.Antonio e Biagio - SC Ematologia Recruiting
Alessandria, Italy, 15121
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Recruiting
Bari, Italy, 70124
Policlinico S. Orsola Malpighi Recruiting
Bologna, Italy, 40138
U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale "Armando Businco" Recruiting
Cagliari, Italy, 09121
Azienda Ospedaliero Universitaria Careggi Recruiting
Firenze, Italy, 50129
AUSL LE/1 - "Vito Fazzii" Hospital Medical Oncology Department Recruiting
Lecce, Italy, 73100
Niguarda Ca' Granda Hospital Withdrawn
Milano, Italy, 20162
Opsedale Maggiore Policlinico and University Recruiting
Milano, Italy, 20122
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello Recruiting
Palermo, Italy, 90146
Azienda Ospedaliera "Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy, 89100
IRCCS Centro di Riferimento Oncologico di Basilicata Recruiting
Rionero in Vulture, Italy, 85028
Policlinico Umberto I Recruiting
Roma, Italy, 00161
Policlinico Universitario "A. Gemelli" Recruiting
Roma, Italy, 00168
Azienda Ospedaliera Universitaria Policlinico Tor Vergata Recruiting
Rome, Italy, 133
Azienda Ospedaliera San Giovanni Battista Recruiting
Torino, Italy, 10126
Ospedale Umberto I Recruiting
Torrette di Ancona, Italy, 60020
Policlinico Univeristario di Udine Recruiting
Udine, Italy, 33100
Ospedale dell'Angelo di Mestre Recruiting
Venezia - Mestre, Italy, 30174
Mexico
Hospital Angeles Lomas Recruiting
Huixquilucan de Degollado, Mexico, 52763
AVIX Investigacion Clínica Recruiting
Monterrey, Mexico, 64710
Hospital Universitario "Dr. Jose E. Gonzalez" Recruiting
Monterrey, Mexico, 64460
Instituto Nacional de Cancerologia Not yet recruiting
Tlalpan, Mexico, 14080
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen Recruiting
Groningen, Netherlands, 9713 GZ
UMC St Radboud Recruiting
Nijmegen, Netherlands, 6500 HB
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3075 EA
Norway
Helse Førde HF Central hospital Recruiting
Førde, Norway, 6807
Oslo University Hospital, Rikshospitalet HF Recruiting
Oslo, Norway, N-0027
Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela Recruiting
Bydgoszcz, Poland, 85-168
Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-952
Uniwersytet Jagiellonski Collegium Medicum Recruiting
Krakow, Poland, 31-501
Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lodz, Poland, 93-510
Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu Recruiting
Torun, Poland, 87-100
Instytut Hematologii i Transfuzjologii, Klinika Hematologii Recruiting
Warszawa, Poland, 02-776
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Recruiting
Wroclaw, Poland, 50-367
Portugal
Hospital Universitário de Coimbra Recruiting
Coimbra, Portugal, 3000-075
Centro Hospitalar de Lisboa central - Hospital de Santo António dos Capuchos Recruiting
Lisboa, Portugal, 1150-314
Instituto Português de Oncologia de Lisboa Recruiting
Lisboa, Portugal, 1099-023
Instituto Português de Oncologia do Porto Recruiting
Porto, Portugal, 4200-072
Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona (Barcelona), Spain, 8916
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 8041
Hospital Universitario Vall D`Hebron Recruiting
Barcelona, Spain, 8035
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28009
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Virgen de la Victoria Recruiting
Malaga, Spain, 29010
Hospital Central de Asturias Recruiting
Oviedo, Spain, 33006
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio Recruiting
Seville, Spain, 41013
Hospital Txagorritxu - Hospital Universitario de Álava Recruiting
Vitoria-Gasteiz, Álava, Spain, 1009
Sweden
SU/Sahlgrenska, Section of Haematology and Coagulation Recruiting
Goeteborg, Sweden, 413 45
University Hospital in Lund Recruiting
Lund, Sweden, 22185
Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 14186
United Kingdom
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom, BS2 8ED
Addenbrookes Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
University Hospital of Wales - Cardiff Recruiting
Cardiff, United Kingdom, CF14 4XW
Northwick Park Hospital Recruiting
Harrow Middlesex, United Kingdom, HA1 3UJ
Queens Centre for Oncology & Haematology Recruiting
Hull, United Kingdom, HU16 5JQ
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Royal Liverpool University Hospital, Prescot Street Recruiting
Liverpool, United Kingdom, L7 8XP
Barts and The London NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Guy's and St Thomas' Hospital - London Recruiting
London, United Kingdom, SE1 9RT
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom, M13 9WL
Nottingham City Hospital - Dept of Haematology Recruiting
Nottingham, United Kingdom, NG5 1PB
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
King's Mill Hospital Recruiting
Sutton in Ashfield, United Kingdom, NG14 45L
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Barry Skikne, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01566695     History of Changes
Other Study ID Numbers: AZA-MDS-003, 2012-002471-34
Study First Received: March 27, 2012
Last Updated: April 24, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland : Office of Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Syndrome
Thrombocytopenia
Blood Platelet Disorders
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Pathologic Processes
Precancerous Conditions
Azacitidine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015