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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)

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ClinicalTrials.gov Identifier: NCT01566695
Recruitment Status : Active, not recruiting
First Posted : March 29, 2012
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
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 or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: Oral Azacitidine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Actual Study Start Date : April 26, 2013
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Red blood cell (RBC) transfusion independence [ Time Frame: Up to 122 months ]
    Red blood cell (RBC) transfusion independence


Secondary Outcome Measures :
  1. Number of patients alive [ Time Frame: Up to 122 months ]
    Number of patients alive

  2. Hematological improvement-platelet response (HI-P) [ Time Frame: Up to 122 months ]
    Hematological improvement-platelet response (HI-P)

  3. Duration of RBC transfusion independence [ Time Frame: Up to 122 months ]
    Duration of RBC transfusion independence

  4. Time to RBC transfusion independence [ Time Frame: Up to 122 months ]
    Time to RBC transfusion independence

  5. Progression to acute myeloid leukemia (AML) [ Time Frame: Up to 122 months ]
    Progression to acute myeloid leukemia (AML)

  6. Time to AML progression [ Time Frame: Up to 122 months ]
    Time to AML progression

  7. Hematological improvement-erythroid response (HI-E) [ Time Frame: Up to 122 months ]
    Hematological improvement-erythroid response (HI-E)

  8. Platelet-transfusion independence [ Time Frame: Up to 122 months ]
    Platelet-transfusion independence

  9. Duration of platelet transfusion independence [ Time Frame: Up to 122 months ]
    Duration of platelet transfusion independence

  10. Time to platelet transfusion independence [ Time Frame: Up to 122 months ]
    Time to platelet transfusion independence

  11. Hematologic response [ Time Frame: Up to 122 months ]
    Hematologic response

  12. Clinically significant bleeding events [ Time Frame: Up to 122 months ]
    Clinically significant bleeding events

  13. Number of subjects with adverse events [ Time Frame: Up to 122 months ]
    Type, frequency, severity of AEs and relationship of AEs to oral azacytidine/placebo; monitoring for progression to AML and secondary primary malignancy

  14. Health-related quality-of-life [ Time Frame: Up to 122 months ]
    Health-related quality-of-life

  15. Healthcare resource utilization [ Time Frame: Up to 122 months ]
    Healthcare resource utilization



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 ( for lenalidomide : unless the last dose received is >= 8 weeks prior to inclusion into the study).
  • 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

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): NCT01566695


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Locations
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Tower Hematology/Oncology Medical Group and Tower Cancer Research Found
Beverly Hills, California, United States, 90211
City of Hope
Duarte, California, United States, 91010-301
California Cancer Associates for Research and Excellence cCARE
Escondido, California, United States, 92025
Marin Oncology Associates
Greenbrae, California, United States, 94904-2007
UCSD-Thornton Hospital
La Jolla, California, United States, 92093-0943
University of Southern California Norris Cancer Center
Los Angeles, California, United States, 90033
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06519
United States, Florida
University of Florida Health Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Georgia
Phoebe Cancer Center of Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
United States, Illinois
Robert H Lurie Comprehensive Cancer Center NW Univ
Chicago, Illinois, United States, 60611
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Chicago
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7233
United States, Kentucky
University of Louisville, J.G. Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Louisiana
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21231
United States, Massachusetts
UMASS Memorial Hospital
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Jackson Oncology Associates PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City, Missouri, United States, 64128
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, New York
Weill Cornell Medical College - New York - Presbyterian Hospital
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Eastern Institute of Medical Sciences
Greenville, North Carolina, United States, 27834
United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106-5000
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Kaiser Permanente Northwest Oncology Hematology
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston, Texas, United States, 78235-8200
MD Anderson Cancer Center The University of Texas
Houston, Texas, United States, 77030
Michael Debakey VA Medical Center
Houston, Texas, United States, 77030
Millenium Oncology
Houston, Texas, United States, 77090
United States, Virginia
VA Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4417
United States, Wisconsin
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States, 53188-5099
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, SA 5000
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Frankston Hospital Oncology Research
Frankston, Victoria, Australia, 3199
Australia
Royal Prince Alfred Hospital, Sydney Cancer Centre
Camperdown, Australia, 2050
The Northern Hospital
Epping, VIC, Australia, 3076
St Vincent's Hospital Melbourne
Fitzroy, Australia, 3065
St George Hospital
Kogarah, Australia, 2217
Cabrini Hospital
Malvern, Australia, 3144
Haematoloy and Oncology Clinics of Australia
Milton, Brisbane, Australia, 4064
Calvary Mater New Castle
Waratah, Australia, NSW
Princess Alexandra Hospital
Woolloongabba, Australia, QLD 4102
Belgium
AZ Klina
Brasschaat, Belgium, 2930
AZ St-Jan Brugge Oostende AV
Brugge, Belgium, 8000
Grand Hopital de Charleroi
Charleroi, Belgium, 6000
UZ Leuven
Leuven, Belgium, 3000
Brazil
Universidade Federal do Ceara
Fortaleza, Ceará, Brazil, 60430370
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
MS INCA HC I Hospital do Cancer I
Rio De Janeiro, Brazil, 20231-130
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
Sao Paulo, Brazil, 05651-901
Canada, Alberta
University of Alberta Hospital Adult Hematology Research
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, LYM6M2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital University Health Network
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
University Hospital Hradec Kralove
Hradec Králové, Czechia, 500 05
University Hospital Olomouc
Olomouc, Czechia, 77520
Vseobecna Fakultni Nemocnice v Praze
Praha, Czechia, 128 08
Ustav hematologie a krevni transfuze
Praha, Czechia, 128 20
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Onk.Dep., Odense Universitets hospital
Odense C, Denmark, 5000
Roskilde Hospital
Roskilde, Denmark, DK-4000
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029 HUS
Turku University Hospital
Turku, Finland, 20521
France
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille, France, 59037
Institute Paoli-Calmettes Service Haematology
Marseille Cedex 9, France, 13009
CHU Nantes Hotel Dieu
Nantes, France, 44093
Hospital Saint Louis
Paris, France, 7575
Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex, France, 69495
CHRU Hôpital de Pontchaillou
Rennes Cedex, France, 35033
Centre Henri Becquerel
Rouen Cedex, France, 76038
Hopital Civil de Strasbourg
Strasbourg, France, 67091
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9, France, 31059
Hopital Bretonneau
Tours, France, 37044
Germany
Gemeinschaftspraxis Haematologie-Onkologie
Dresden, Germany, 01307
Universitatsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Marien Hospital
Duesseldorf, Germany, 40479
Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie
Dusseldorf, Germany, 40225
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Universitatsklinikum Schleswig-Holstein
Keil, Germany, 24105
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
TU München - Klinikum rechts der Isar
München, Germany, 81675
University-Hospital Tübingen
Tubingen, Germany, 72076
Universitatsklinikum Ulm
Ulm, Germany, 89081
Greece
Democritus University of Thrace
Alexandroupolis, Greece, 68100
Evangelismos General Hospital of Athens
Athens, Greece, 10676
Laiko General Hospital
Athens, Greece, 11527
Attikon General University Hospital of Athens
Athens, Greece, 124 62
University General Hospital of Heraklion
Heraklion, Greece, 71110
University of Patras
Patras, Greece, 26500
Israel
Rambam Medical Center
Haifa, Israel, 31096
Rabin Medical Center
Petach Tikva, Israel, 49100
Sheba Medical Center
Tel Hashomer, Israel, 52621
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Italy
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria, Italy, 15121
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale Armando Businco
Cagliari, Italy, 09121
Azienda Ospedaliero Universitaria Careggi
Firenze, Italy, 50129
AUSL LE1 - Vito Fazzii Hospital Medical Oncology Department
Lecce, Italy, 73100
Opsedale Maggiore Policlinico and University
Milano, Italy, 20122
IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
Milan, Italy, 20089
A.O.U. Maggiore della Carità
Novara, Italy, 28100
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy, 90146
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Ospedale S. Chiara
Pisa, Italy, 56126
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy, 89100
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture, Italy, 85028
Fondazione PTV Policlinico Tor Vergata
Roma, Italy, 00133
Policlinico Umberto I
Roma, Italy, 00161
Policlinico Universitario "A. Gemelli"
Roma, Italy, 00168
AO Santa Maria
Terni, Italy, 05100
Azienda Ospedaliera San Giovanni Battista
Torino, Italy, 10126
Ospedale Umberto I
Torrette Di Ancona, Italy, 60020
Policlinico Univeristario di Udine
Udine, Italy, 33100
Ospedale dell Angelo di Mestre
Venezia - Mestre, Italy, 30174
Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of, 614-735
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
Seoul St Marys Hospital College of Medicine The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Mexico
Hospital Angeles Lomas - Consultorio 830
Huixquilucan de Degollado, Mexico, 52763
Hospital Universitario "Dr. Jose E. Gonzalez"
Monterrey, Mexico, 64460
AVIX Investigacion Clinica
Monterrey, Mexico, 64710
Instituto Nacional de Cancerologia
Tlalpan, Mexico, 14080
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
UMC St Radboud
Nijmegen, Netherlands, 6500 HB
Erasmus Medical Center
Rotterdam, Netherlands, 3075 EA
Norway
Helse Forde HF Central hospital
Førde, Norway, 6807
Oslo University Hospital, Rikshospitalet HF
Oslo, Norway, N-0027
Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz, Poland, 85-168
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Uniwersytet Jagiellonski Collegium Medicum
Krakow, Poland, 31-501
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu
Torun, Poland, 87-100
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warszawa, Poland, 02-097
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warszawa, Poland, 02-776
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Wroclaw, Poland, 50-367
Portugal
ULSBA (Unidade Local de Saúde do Baixo Alentejo, EPE) - Hospital de Beja
Beja, Portugal, 7801-849
Hospital Universitario de Coimbra
Coimbra, Portugal, 3000-075
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
Porto, Portugal, 4200-072
Spain
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), Spain, 8916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitario Vall D Hebron
Barcelona, Spain, 8035
Complejo Hospitalario Universitario de Granada
Granada, Spain, 18014
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28009
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Central de Asturias
Oviedo, Spain, 33006
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen del Rocio
Seville, Spain, 41013
Hospital Txagorritxu - Hospital Universitario de Álava
Vitoria-Gasteiz, Álava, Spain, 1009
Sweden
SU/Sahlgrenska, Section of Haematology and Coagulation
Goeteborg, Sweden, 413 45
University Hospital in Lund
Lund, Sweden, 22185
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Turkey
Baskent University Medical Faculty Adana Practice and Research Center
Adana, Turkey, 01250
Antalya Egitim Arastirma
Antalya, Turkey, 07100
Istanbul University Cerrahpasa
Istanbul, Turkey, 34098
Istanbul University Faculty of Medicine
Istanbul, Turkey, 34390
Mersin University Medical Faculty
Mersin, Turkey, 33343
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon, Turkey, 61080
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
University Hospital of Wales - Cardiff
Cardiff, United Kingdom, CF14 4XW
Northwick Park Hospital
Harrow Middlesex, United Kingdom, HA1 3UJ
Queens Centre for Oncology & Haematology
Hull, United Kingdom, HU16 5JQ
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Royal Liverpool University Hospital, Prescot Street
Liverpool, United Kingdom, L7 8XP
Barts and The London NHS Trust
London, United Kingdom, EC1A 7BE
Guy's and St Thomas' Hospital - London
London, United Kingdom, SE1 9RT
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Nottingham City Hospital - Dept of Haematology
Nottingham, United Kingdom, NG5 1PB
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Kings Mill Hospital
Sutton in Ashfield, United Kingdom, NG17 4SL
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Celgene
Investigators
Study Director: Ignazia Ignazia La Torre, MD Celgene Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT01566695     History of Changes
Other Study ID Numbers: AZA-MDS-003
2012-002471-34 ( EudraCT Number )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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