Clinical Trial Details

NCT ID: NCT01566695
Date Last Changed: October 2, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Oral Azacitidine and Placebo to evaluate Myelodysplastic Syndrome

Research Study 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.

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).

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Celgene
Duration
102 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

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

Site Locations (138)

Country State City Zip Facility and Contact
United States California Duarte 91010-301 City of Hope
United States California Los Angeles 90033 University of Southern California Norris Cancer Center
United States Connecticut New Haven 06519 Yale Cancer Center
United States Florida Orlando 32806 University of Florida Health Cancer Center at Orlando Health
United States Illinois Chicago 60612 University of Illinois at Chicago
United States Illinois Maywood 60153 Loyola University Chicago
United States Kentucky Louisville 40202 University of Louisville, J.G. Brown Cancer Center
United States Missouri Kansas City 64128 Kansas City VA Medical Center University of Kansas Medical Center
United States Nebraska Omaha 68198-6805 University of Nebraska Medical Center
United States New York New York 10021 Weill Cornell Medical College - New York - Presbyterian Hospital
United States Texas Fort Sam Houston 78235-8200 Brooke Army Medical Center Francis Street Medical Center
United States Texas Houston 77030 MD Anderson Cancer Center The University of Texas
United States Texas Houston 77090 Millenium Oncology
United States Wisconsin Waukesha 53188-5099 Waukesha Memorial Hospital
Australia Australian Capital Territory Garran 2605 Canberra Hospital
Australia South Australia Adelaide SA 5000 Royal Adelaide Hospital
Australia Victoria Clayton 3168 Monash Medical Centre
Australia Victoria Frankston 3199 Frankston Hospital Oncology Research
Australia Camperdown 2050 Royal Prince Alfred Hospital, Sydney Cancer Centre
Australia Fitzroy 3065 St Vincent's Hospital Melbourne
Australia Kogarah 2217 St George Hospital
Australia Malvern 3144 Cabrini Hospital
Australia Waratah NSW Calvary Mater New Castle
Australia Woolloongabba QLD 4102 Princess Alexandra Hospital
Belgium Brasschaat 2930 AZ Klina
Belgium Brugge 8000 AZ St-Jan Brugge Oostende AV
Belgium Charleroi 6000 Grand Hopital de Charleroi
Belgium Leuven 3000 UZ Leuven
Brazil Rio Grande do Sul Porto Alegre 90035-903 Hospital de Clínicas de Porto Alegre
Brazil Rio De Janeiro 20231-130 MS INCA HC I Hospital do Cancer I
Brazil Sao Paulo 05651-901 Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira
Canada Alberta Edmonton T6G 2B7 University of Alberta Hospital Adult Hematology Research
Canada Ontario Barrie LYM6M2 Royal Victoria Hospital, Barrie
Canada Ontario Hamilton L8V 5C2 Juravinski Cancer Centre
Canada Ontario Toronto M4N 3M5 Sunnybrook Health Sciences Centre
Canada Ontario Toronto M5G 2M9 Princess Margaret Hospital University Health Network
Canada Quebec Montreal H4J 1C5 Hopital du Sacre-Coeur de Montreal
Czechia Brno 625 00 Fakultni nemocnice Brno
Czechia Hradec Králové 500 05 University Hospital Hradec Kralove
Czechia Olomouc 77520 University Hospital Olomouc
Czechia Praha 128 08 Vseobecna Fakultni Nemocnice v Praze
Czechia Praha 128 20 Ustav hematologie a krevni transfuze
Finland Helsinki 00029 HUS Helsinki University Central Hospital
Finland Turku 20521 Turku University Hospital
France Lille 59037 CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang
France Marseille Cedex 9 13009 Institute Paoli-Calmettes Service Haematology
France Nantes 44093 CHU Nantes Hotel Dieu
France Paris 7575 Hospital Saint Louis
France Pierre-Bénite Cedex 69495 Centre Hospitalier Lyon Sud
France Rennes Cedex 35033 CHRU Hôpital de Pontchaillou
France Rouen Cedex 76038 Centre Henri Becquerel
France Strasbourg 67091 Hopital Civil de Strasbourg
France Toulouse Cedex 9 31059 Institut Universitaire du Cancer de Toulouse - Oncopole
France Tours 37044 Hopital Bretonneau
Germany Dresden 01307 Gemeinschaftspraxis Haematologie-Onkologie
Germany Dresden 01307 Universitatsklinikum Carl Gustav Carus
Germany Duesseldorf 40479 Marien Hospital
Germany Keil 24105 Universitatsklinikum Schleswig-Holstein
Germany Leipzig 04103 Universitatsklinikum Leipzig
Germany München 81675 TU München - Klinikum rechts der Isar
Germany Tubingen 72076 University-Hospital Tübingen
Germany Ulm 89081 Universitatsklinikum Ulm
Greece Alexandroupolis 68100 Democritus University of Thrace
Greece Athens 10676 Evangelismos General Hospital of Athens
Greece Heraklion 71110 University General Hospital of Heraklion
Greece Patras 26500 University of Patras
Israel Tel Hashomer 52621 Sheba Medical Center
Israel Tel-Aviv 64239 Tel-Aviv Sourasky Medical Center
Italy Alessandria 15121 Az. Osp. SS.Antonio e Biagio - SC Ematologia
Italy Bari 70124 Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Italy Bologna 40138 Policlinico S. Orsola Malpighi
Italy Cagliari 09121 U.O. Ematologia. Ospedale Oncologico di Riferimento Regionale "Armando Businco"
Italy Firenze 50129 Azienda Ospedaliero Universitaria Careggi
Italy Milano 20122 Opsedale Maggiore Policlinico and University
Italy Milan 20089 IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center
Italy Novara 28100 A.O.U. Maggiore della Carità
Italy Palermo 90146 Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Italy Pavia 27100 Fondazione IRCCS Policlinico San Matteo
Italy Pisa 56126 Ospedale S. Chiara
Italy Reggio Calabria 89100 Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Italy Rionero in Vulture 85028 IRCCS Centro di Riferimento Oncologico di Basilicata
Italy Roma 00133 Fondazione PTV Policlinico Tor Vergata
Italy Roma 00161 Policlinico Umberto I
Italy Roma 00168 Policlinico Universitario "A. Gemelli"
Italy Terni 05100 AO Santa Maria
Italy Torrette di Ancona 60020 Ospedale Umberto I
Italy Udine 33100 Policlinico Univeristario di Udine
Mexico Huixquilucan de Degollado 52763 Hospital Angeles Lomas - Consultorio 830
Mexico Monterrey 64710 AVIX Investigacion Clinica
Mexico Tlalpan 14080 Instituto Nacional de Cancerologia
Netherlands Amsterdam 1081 HV VU University Medical Center
Netherlands Groningen 9713 GZ Universitair Medisch Centrum Groningen
Poland Bydgoszcz 85-168 Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Poland Gdansk 80-952 Uniwersyteckie Centrum Kliniczne
Poland Lodz 93-510 Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Poland Torun 87-100 Specjalistyczny Szpital Miejski im. M. Kopernika w Toruniu
Poland Warszawa 02-097 Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Poland Warszawa 02-776 Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Poland Wroclaw 50-367 Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Portugal Beja 7801-849 ULSBA (Unidade Local de Saúde do Baixo Alentejo, EPE) - Hospital de Beja
Portugal Coimbra 3000-075 Hospital Universitario de Coimbra
Portugal Lisboa 1099-023 Instituto Portugues de Oncologia de Lisboa
Portugal Lisboa 1150-314 Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Portugal Porto 4200-072 Instituto Portugues de Oncologia do Porto
Spain Badalona (Barcelona) 8916 Hospital Universitari Germans Trias i Pujol
Spain Barcelona 08025 Hospital de la Santa Creu i Sant Pau
Spain Barcelona 8035 Hospital Universitario Vall D Hebron
Spain Granada 18014 Complejo Hospitalario Universitario de Granada
Spain Madrid 28009 Hospital General Universitario Gregorio Maranon
Spain Madrid 28034 Hospital Ramon y Cajal
Spain Madrid 28046 Hospital Universitario La Paz
Spain Malaga 29010 Hospital Universitario Virgen de la Victoria
Spain Oviedo 33006 Hospital Central de Asturias
Spain Salamanca 37007 Hospital Universitario de Salamanca
Spain Seville 41013 Hospital Universitario Virgen del Rocio
Spain Vitoria-Gasteiz, Álava 1009 Hospital Txagorritxu - Hospital Universitario de Álava
Sweden Goeteborg 413 45 SU/Sahlgrenska, Section of Haematology and Coagulation
Sweden Lund 22185 University Hospital in Lund
Sweden Stockholm 14186 Karolinska University Hospital Huddinge
Turkey Antalya 07100 Antalya Egitim Arastirma
Turkey Istanbul 34098 Istanbul University Cerrahpasa
Turkey Istanbul 34390 Istanbul University Faculty of Medicine
Turkey Mersin 33343 Mersin University Medical Faculty
Turkey Trabzon 61080 Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
United Kingdom Aberdeen AB25 2ZN Aberdeen Royal Infirmary
United Kingdom Birmingham B9 5SS Birmingham Heartlands Hospital
United Kingdom Bristol BS2 8ED Bristol Haematology and Oncology Centre
United Kingdom Cambridge CB2 0QQ Addenbrookes Hospital
United Kingdom Cardiff CF14 4XW University Hospital of Wales - Cardiff
United Kingdom Harrow Middlesex HA1 3UJ Northwick Park Hospital
United Kingdom Hull HU16 5JQ Queens Centre for Oncology & Haematology
United Kingdom Leicester LE1 5WW Leicester Royal Infirmary
United Kingdom London SE1 9RT Guy's and St Thomas' Hospital - London
United Kingdom Manchester M13 9WL Manchester Royal Infirmary
United Kingdom Nottingham NG5 1PB Nottingham City Hospital - Dept of Haematology
United Kingdom Oxford OX3 9DU John Radcliffe Hospital
United Kingdom Sutton in Ashfield NG17 4SL Kings Mill Hospital
United Kingdom Wolverhampton WV10 0QP New Cross Hospital

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