358
Participants
Start Date
November 1, 2003
Primary Completion Date
July 1, 2007
Study Completion Date
July 1, 2007
Azacitidine
Azacitidine was injected subcutaneously (SC) at an initial dose of 75mg/m\^2/day for 7 days. The 7-day dosing was repeated every 28 days with dose adjustment based on predefined hematology and renal laboratory results. Number of cycles: Azacitidine treatment was to be continued until the end of the study unless treatment was discontinued due to unacceptable toxicity, relapse after complete or partial response, transformation to AML or disease progression.
Physician Choice
"Physician Choice was one of three options:~* Best supportive care (BSC) alone,~* Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or~* Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone) on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70 days from the start of the previous cycle).~All three options included best supportive care"
"Instituto Nazionale Tumori Regina Elena", Roma
Orszagos Gyogyintezeti Kozpont, Budapest
Universitatsklinikum Carl Gustav Carus, Dresden
National Centre of Hematology and Transfusiology, Sofia, Sofia
Royal North Shore Hospital, St Leonards
Liverpool Hospital, Liverpool
The Newcastle Mater Miseriecordiae Hospital, Warratah
Peter MacCallum Cancer Institute, East Melbourne
"Multiprofile Hospital for Active Treatment (MHAT), St. Marina Clinic of Hematology", Varna
Royal Melbourne Hospital, Melbourne
The Alfred Hospital, Melbourne
"MHAT St George Clinic of Hematology, Plovdiv", Plovdiv
III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU), Plovdiv
Royal Brisbane Hospital, Hersten
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital, Adelaide
First Clinical Base - Clinic of Hematology, MHAT - Pleven, Pleven
University of Szeged, 2nd Department of Internal Medicine, Szeged
The Royal Perth Hospital, Perth
Universita Degli Studi Di Sassari, Sassari
University of Pecs, 1st Dept of Internal Medicine, Pécs
"University Multiprofile Hospital for Active Treatment Sveta Marina", Varna
Klinikum Chemnitz gGmbH, Chemnitz
District General Hospital of Athens, Athens
General Hospital of Chest Disease, Athens
University Hospital-Attikon, Haidari
Institute Paoli Calmettes, Marseille
Huddinge University Hospital, Stockholm
Western Pennsylvania Cancer Institute, Pittsburgh
Samodzielny Publiczny Szpital Kliniczny, Lublin
Instituto Nazionale Dei Tumori, Milan
Lund Universtiy Hospital, Lund
Hospital de Leon, León
University General Hospital of Patra Rio, Pátrai
Hospital Universitario De La Princesa, Madrid
Hospital Ramon Y Cajal, Madrid
Hospital La Paz, Madrid, Madrid
Hospital Clinico San Carlos, Madrid
Chu Purpan, Toulouse
University of Alabama School of Medicine, Birmingham
Hospital Universitario Del Salamanca, Salamanca
Gerorg-August-Universitat Gottingen, Göttingen
Policlinico S. Orsola-Malpighi, Bologna
Heinrich-Heine University Dusseldorf, Düsseldorf
Centro Oncologico Modenese, Modena
Chu De Nantes, Nantes
Case Western Reserve University, Cleveland
University Essen, Essen
University General Hospital of Ioannina, Ioannina
Hospital Universitario La Fe, Valencia
Indiana University Cancer Center, Indianapolis
St Johannes Hospital, Duisburg
Chu D'Angers, Angers
Universita di Firenze, Florence
Universitatsklinikum Bonn, Bonn
Froedtert Memorial Lutheran Hospital, Milwaukee
Che De Lille, Lille
Washington University School of Medicine, St Louis
Hospital Edouard Herriot, Lyon
Ospedale Casa Sollievo Della Sofferenza - Irrc, San Giovanni Rotondo
University General Hospital of Heraklio Voutes, Heraklio
Hospital Saint Louis, Paris
Hopital Cochin, Paris
Centre Henri Becquerel, Rouen
Universitatsklinikum Ulm, Ulm
Hopital Beaujon, Clichy
Oregon Cancer Center, Portland
Burdenko Central Military Clinical Hospital, Moscow
Blokhin Cancer Research Center, Moscow
Scientific Haematology Center, Moscow, Moscow
Institute of Haematology & Blood Transfusion, Saint Petersburg
Pavlov State Medical University, Saint Petersburg
Pavlov State Medical University, Saint Petersburg
City Hospital #31, Saint Petersburg
Mount Sinai Medical Center, New York
Fakultni nemocnice Brno, Jihlavska
Fakultni nemocnice Hradec Kralove, Sokolska
Fakultni Nemocnice Olomouc, Olomouc
Vseobecna Fakultni Nemocnice, Prague
Uslav Hematologie a Krevni Transfuze, Prague
Universitatsklinikum Benjamin Franklin, Hindenburgdamm
Allgemeines Krankenhaus St. Georg, Hamburg
Universitatsklinikum Hambur-Eppendorf, Hamburg
Universitatsklinikum Kiel II, Kiel
Ospedale San Martino, Genova
Ospedale San Eugenio, Roma
Policlinico Gemelli, Roma
VU University Medical Center Amsterdam, Amsterdam
Univ Hospital St. Radboud, Nijmejen
Hospital Universitario Germans Trias I Pujol, Barcelona
Kings College Hospital NHS Trust, London
Samodzielny Publiczny Szpital Kliniczny Nr 1, Gdansk
Wojewodzki Szpital Specjalistyczny, Lodz
Wojskowy Instytut Medyczny, Warsaw
Samodzelny Publiczny Centralny Szpital Kliniczny, Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw
Hospital Santa Creu I Sant Pau, Barcelona
Hospital Clinic, Barcelona
Hospital Son Llatzer, Palma de Mallorca
Sahlgrenska University Hospital, Gothenburg
University Hospital MAS, Malmo
Uppsala University Hospital, Uppsala
Royal Bournemouth General Hospital, Bournemouth
St. Bartholomew's Hospital, London
Christie Hospital, Manchester
Norfolk and Norwich University Hospital, Norwich
John Radcliffe Hospital, Oxford
Royal Cornwall Hospital, Truro
Lead Sponsor
Celgene
INDUSTRY