Myelodysplastic Syndrome Clinical Trial

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)

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).

View Eligibility Criteria

Eligibility 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.
Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted

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

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT01566695

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 194 Locations for this study

See Locations Near You

Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
Tower Hematology/Oncology Medical Group and Tower Cancer Research Found
Beverly Hills California, 90211, United States
City of Hope
Duarte California, 91010, United States
California Cancer Associates for Research and Excellence cCARE
Escondido California, 92025, United States
Marin Oncology Associates
Greenbrae California, 94904, United States
UCSD-Thornton Hospital
La Jolla California, 92093, United States
University of Southern California Norris Cancer Center
Los Angeles California, 90033, United States
Yale Cancer Center
New Haven Connecticut, 06519, United States
University of Florida Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Phoebe Cancer Center of Phoebe Putney Memorial Hospital
Albany Georgia, 31701, United States
Robert H Lurie Comprehensive Cancer Center NW Univ
Chicago Illinois, 60611, United States
University of Illinois at Chicago
Chicago Illinois, 60612, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Loyola University Chicago
Maywood Illinois, 60153, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
University of Louisville, J.G. Brown Cancer Center
Louisville Kentucky, 40202, United States
Hematology and Oncology Specialists, LLC
Metairie Louisiana, 70006, United States
Johns Hopkins Medicine
Baltimore Maryland, 21231, United States
UMASS Memorial Hospital
Worcester Massachusetts, 01655, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Jackson Oncology Associates PLLC
Jackson Mississippi, 39202, United States
Saint Luke's Cancer Institute
Kansas City Missouri, 64111, United States
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City Missouri, 64128, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Weill Cornell Medical College - New York - Presbyterian Hospital
New York New York, 10021, United States
Icahn School of Medicine at Mount Sinai Medical Center
New York New York, 10029, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Eastern Institute of Medical Sciences
Greenville North Carolina, 27834, United States
University Hospitals of Cleveland Case Medical Center
Cleveland Ohio, 44106, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Kaiser Permanente Northwest Oncology Hematology
Portland Oregon, 97227, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Western Pennsylvania Cancer Institute
Pittsburgh Pennsylvania, 15224, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston Texas, 78235, United States
MD Anderson Cancer Center The University of Texas
Houston Texas, 77030, United States
Michael Debakey VA Medical Center
Houston Texas, 77030, United States
Millenium Oncology
Houston Texas, 77090, United States
VA Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States
Canberra Hospital
Garran Australian Capital Territory, 2605, Australia
Royal Adelaide Hospital
Adelaide South Australia, SA 50, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Frankston Hospital
Frankston Victoria, 3199, Australia
Royal Prince Alfred Hospital, Sydney Cancer Centre
Camperdown , 2050, Australia
The Northern Hospital
Epping, VIC , 3076, Australia
St Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
St George Hospital
Kogarah , 2217, Australia
Cabrini Hospital
Malvern , 3144, Australia
Local Institution - 130
Malvern , 3144, Australia
Haematoloy and Oncology Clinics of Australia
Milton, Brisbane , 4064, Australia
Calvary Mater New Castle
Waratah , NSW, Australia
Princess Alexandra Hospital
Woolloongabba , QLD 4, Australia
Algemeen Ziekenhuis Klina
Brasschaat , 2930, Belgium
AZ St-Jan Brugge Oostende AV
Brugge , 8000, Belgium
Grand Hopital de Charleroi
Charleroi , 6000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Universidade Federal do Ceara
Fortaleza Ceará, 60430, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Hospital Erasto Gaertner
Curitiba , 81520, Brazil
MS INCA HC I Hospital do Cancer I
Rio De Janeiro , 20231, Brazil
Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
Sao Paulo , 05651, Brazil
University of Alberta Hospital Adult Hematology Research
Edmonton Alberta, T6G 2, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
Royal Victoria Hospital, Barrie
Barrie Ontario, LYM6M, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Local Institution - 180
Hamilton Ontario, L8V 5, Canada
Local Institution - 179
Toronto Ontario, M4N 3, Canada
Sunnybrook Health Sciences Centre
Toronto Ontario, M4N 3, Canada
Princess Margaret Hospital University Health Network
Toronto Ontario, M5G 2, Canada
Local Institution - 181
Montreal Quebec, H2W 1, Canada
McGill University, Dept. Oncology Clinical Research Program
Montreal Quebec, H2W 1, Canada
Hopital du Sacre-Coeur de Montreal
Montreal Quebec, H4J 1, Canada
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Local Institution - 230
Hradec Králové , 500 0, Czechia
University Hospital Hradec Kralove
Hradec Králové , 500 0, Czechia
University Hospital Olomouc
Olomouc , 77520, Czechia
Vseobecna Fakultni Nemocnice v Praze
Praha , 128 0, Czechia
Ustav hematologie a krevni transfuze
Praha , 128 2, Czechia
Aarhus University Hospital
Aarhus , 8000, Denmark
Onk.Dep., Odense Universitets hospital
Odense C , 5000, Denmark
Roskilde Hospital
Roskilde , DK-40, Denmark
Helsinki University Central Hospital
Helsinki , 00029, Finland
Turku University Hospital
Turku , 20521, Finland
CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
Lille , 59037, France
Local Institution - 305
Lille , 59037, France
Institute Paoli-Calmettes Service Haematology
Marseille Cedex 9 , 13009, France
CHU Nantes Hotel Dieu
Nantes , 44093, France
Hospital Saint Louis
Paris , 7575, France
Local Institution - 308
Paris , 7575, France
Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex , 69495, France
CHRU Hôpital de Pontchaillou
Rennes Cedex , 35033, France
Centre Henri Becquerel
Rouen Cedex , 76038, France
Hopital Civil de Strasbourg
Strasbourg , 67091, France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse Cedex 9 , 31059, France
Local Institution - 300
Toulouse Cedex 9 , 31059, France
Hopital Bretonneau
Tours , 37044, France
Gemeinschaftspraxis Haematologie-Onkologie
Dresden , 01307, Germany
Local Institution - 350
Dresden , 01307, Germany
Universitatsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Local Institution - 359
Duesseldorf , 40479, Germany
Marien Hospital
Duesseldorf , 40479, Germany
Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie
Dusseldorf , 40225, Germany
Asklepios Klinik St. Georg
Hamburg , D-200, Germany
Universitatsklinikum Schleswig-Holstein
Keil , 24105, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
TU München - Klinikum rechts der Isar
München , 81675, Germany
University Hospital Tubingen
Tubingen , 72076, Germany
Universitatsklinikum Ulm
Ulm , 89081, Germany
Democritus University of Thrace
Alexandroupolis , 68100, Greece
Evangelismos General Hospital of Athens
Athens , 10676, Greece
Laiko General Hospital
Athens , 11527, Greece
Attikon General University Hospital of Athens
Athens , 124 6, Greece
University General Hospital of Heraklion
Heraklion , 711 1, Greece
University of Patras
Patras , 26500, Greece
Rambam Medical Center
Haifa , 31096, Israel
Rabin Medical Center
Petach Tikva , 49100, Israel
Sheba Medical Center
Tel Hashomer , 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Az. Osp. SS.Antonio e Biagio - SC Ematologia
Alessandria , 15121, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari , 70124, Italy
Policlinico S. Orsola Malpighi
Bologna , 40138, Italy
U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale Armando Businco
Cagliari , 09121, Italy
Azienda Ospedaliero Universitaria Careggi
Firenze , 50129, Italy
AUSL LE1 - Vito Fazzii Hospital Medical Oncology Department
Lecce , 73100, Italy
Local Institution - 479
Lecce , 73100, Italy
Local Institution - 488
Milano , 20122, Italy
Opsedale Maggiore Policlinico and University
Milano , 20122, Italy
IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
Milan , 20089, Italy
A.O.U. Maggiore della Carità
Novara , 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo , 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Local Institution - 495
Pavia , 27100, Italy
Ospedale S. Chiara
Pisa , 56126, Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria , 89100, Italy
Local Institution - 485
Reggio Calabria , 89133, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata
Rionero in Vulture , 85028, Italy
Fondazione PTV Policlinico Tor Vergata
Roma , 00133, Italy
Policlinico Umberto I
Roma , 00161, Italy
Policlinico Universitario "A. Gemelli"
Roma , 00168, Italy
AO Santa Maria
Terni , 05100, Italy
Azienda Ospedaliera San Giovanni Battista
Torino , 10126, Italy
Ospedale Umberto I
Torrette Di Ancona , 60020, Italy
Policlinico Univeristario di Udine
Udine , 33100, Italy
Ospedale dell Angelo di Mestre
Venezia - Mestre , 30174, Italy
Inje University Busan Paik Hospital
Busan , 614-7, Korea, Republic of
Kyungpook National University Hospital
Daegu , 700-7, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 120-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Seoul St Marys Hospital College of Medicine The Catholic University of Korea
Seoul , 137-7, Korea, Republic of
Hospital Angeles Lomas - Consultorio 830
Huixquilucan de Degollado , 52763, Mexico
Hospital Universitario "Dr. Jose E. Gonzalez"
Monterrey , 64460, Mexico
Local Institution - 828
Monterrey , 64460, Mexico
AVIX Investigacion Clinica
Monterrey , 64710, Mexico
Instituto Nacional de Cancerologia
Tlalpan , 14080, Mexico
VU University Medical Center
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
UMC St Radboud
Nijmegen , 6500 , Netherlands
Erasmus Medical Center
Rotterdam , 3075 , Netherlands
Helse Forde HF Central hospital
Førde , 6807, Norway
Oslo University Hospital, Rikshospitalet HF
Oslo , N-002, Norway
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz , 85-16, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Uniwersytet Jagiellonski Collegium Medicum
Krakow , 31-50, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Local Institution - 580
Torun , 87-10, Poland
Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu
Torun , 87-10, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warszawa , 02-09, Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warszawa , 02-77, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Wroclaw , 50-36, Poland
ULSBA (Unidade Local de Saúde do Baixo Alentejo, EPE) - Hospital de Beja
Beja , 7801-, Portugal
Hospital Universitario de Coimbra
Coimbra , 3000-, Portugal
Instituto Portugues de Oncologia de Lisboa
Lisboa , 1099-, Portugal
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa , 1150-, Portugal
Instituto Portugues de Oncologia do Porto
Porto , 4200-, Portugal
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona) , 8916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Universitario Vall D Hebron
Barcelona , 8035, Spain
Complejo Hospitalario Universitario de Granada
Granada , 18014, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28009, Spain
Hospital Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario Virgen de la Victoria
Malaga , 29010, Spain
Hospital Central de Asturias
Oviedo , 33006, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Seville , 41013, Spain
Hospital Txagorritxu - Hospital Universitario de Álava
Vitoria-Gasteiz, Álava , 1009, Spain
SU/Sahlgrenska, Section of Haematology and Coagulation
Goeteborg , 413 4, Sweden
University Hospital in Lund
Lund , 22185, Sweden
Local Institution - 652
Lund , 222 4, Sweden
Karolinska Universitetssjukhuset - Huddinge
Stockholm , 14186, Sweden
Baskent University Medical Faculty Adana Practice and Research Center
Adana , 01250, Turkey
Antalya Egitim Arastirma
Antalya , 07100, Turkey
Istanbul University Cerrahpasa
Istanbul , 34098, Turkey
Istanbul University Faculty of Medicine
Istanbul , 34390, Turkey
Mersin University Medical Faculty
Mersin , 33343, Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon , 61080, Turkey
Local Institution - 685
Oxford Oxfordshire, OX3 9, United Kingdom
Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
University Hospital of Wales - Cardiff
Cardiff , CF14 , United Kingdom
Northwick Park Hospital
Harrow Middlesex , HA1 3, United Kingdom
Queens Centre for Oncology & Haematology
Hull , HU16 , United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Royal Liverpool University Hospital, Prescot Street
Liverpool , L7 8X, United Kingdom
Barts and The London NHS Trust
London , EC1A , United Kingdom
Guy's and St Thomas' Hospital - London
London , SE1 9, United Kingdom
Manchester Royal Infirmary
Manchester , M13 9, United Kingdom
Nottingham City Hospital - Dept of Haematology
Nottingham , NG5 1, United Kingdom
John Radcliffe Hospital
Oxford , OX3 9, United Kingdom
Kings Mill Hospital
Sutton in Ashfield , NG17 , United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT01566695

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.