Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML)

PHASE3CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

June 1, 2010

Primary Completion Date

January 22, 2014

Study Completion Date

July 25, 2016

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Azacitidine

75 mg/m\^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity

DRUG

Conventional Care Regimen

"Physician pre-selects prior to randomization from one of the following:~* Intensive chemotherapy (cytarabine 100-200 mg/m\^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles~* Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity~* Best Supportive Care only; until study end"

Trial Locations (112)

1160

Wilhelminenspital, I Medizinische Abt., Vienna

2031

Prince of Wales Hospital, Randwick

3002

Peter MacCallum Cancer Centre, East Melbourne

3011

Western Hospital, Footscray

3050

Royal Melbourne Hospital, Melbourne

3065

St Vincent's Hospital, Fitzroy

4600

Klinikum Wels-Grieskirchen GmbH, Wels

5000

Royal Adelaide Hospital, Adelaide

5020

Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung, Salzburg

5530

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

6000

Grand Hôpital de Charleroi, Charleroi

7100

Centre Hospitalier de Jolimont-Lobbes, La Louvière

8000

Algemeen Ziekenhuis Sint-Jan, Bruges

9000

Universitair Ziekenhuis Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10043

"Azienda Sanitaria Ospedaliera San Luigi Gonzaga", Orbassano

11217

Taipei Veterans General Hospital Pei-Tou District, Taipei

13385

Hôpital de la Conception, Marseille

15121

Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria

18057

University of Rostock, Div. of Haematology and Oncology, Rostock

21100

Ospedale di Circolo e Fondazione Macchi, Varese

28009

Hospital General Universitario Gregorio Marañon, Madrid

31059

Centre Hospitalier Universitaire de Toulouse, Toulouse

33006

Hospital Central de Asturias, Oviedo

33100

Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine

37007

Hospital Universitario de Salamanca, Salamanca

40138

Azienda Ospedaliera Sant'Orsola Malpighi, Bologna

40211

Heinrich-Heine-Universität Düsseldorf, Düesseldorf

41013

Hospital Universitario Virgen del Rocío, Seville

44093

Centre Hospitalier Universitaire Nantes, Hotel Dieu, Nantes

45122

Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie, Essen

46009

Hospital Universitario La Fe, Valencia

49100

Rabin Medical Center, Petah Tikva

49933

CHRU d'Angers, Angers

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

52621

Chaim Sheba Medical Center - Tel Hashomer, Heart Institute, Tel Litwinsky

60126

Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona, Ancona

64109

Centre Hospitalier de la Cote Basque, Aquitaine

64239

Sourasky Medical Center, Tel Aviv

67091

Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre, Strasbourg

69120

Universitatsklinikum Heidelberg, Heidelberg

69437

Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot, Lyon

70124

Azienda Ospedaliera Policlinico di Bari, Bari

70300

Assaf Harofeh Medical Centre, Beer Yaakov

75475

Hôpital Saint Louis, Paris

77030

MD Anderson Cancer Center, Houston

80054

Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud, Amiens

83301

Chang Gung Memorial Hospital, Kaohsiung, Niao-Sung Hsiang

84101

Soroka Medical Center, Beersheba

85028

IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture, Rionero in Vulture

87042

Centre Hopitalier Universitaire Dupuytren, Limoges

89081

Universitätsklinikum Ulm, Ulm

89100

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center, Jerusalem

92141

Hopital Percy Clamart, Clamart

93009

Hospital Avicenne, Service d'hematologie Clinique, Bobigny

100083

The Third Hospital of Peking University, Beijing

100730

Peking Union Medical College Hospital, Beijing

125284

City Clinical Hospital n.a. S. P. Botkin, Moscow

197089

Saint Petersburg State Academician I.P. Pavlov Medical University, Saint Petersburg

200025

Shanghai Ruijin Hospital, Shanghai

200433

Shanghai Changhai Hospital,the Second Military Medical University, Shanghai

210029

Peoples Hospital of Jiangsu Province, Jiangsu

603126

"State Healthcare Institution Nizhny Novgorod N.A. Semashko Regional Clinical Hospital", Nizhny Novgorod

610041

West China Hospital,Sichuan University, Sichuan

620137

Central City Hospital # 7, Yekaterinburg

3000200

Tianjin Blood Disease Hospital, Tianjin

02115

Massachusetts General Hospital, Boston

T6G 2B7

University of Alberta Hospital, Edmonton

R3E 0V9

Cancer Care Manitoba, Winnipeg

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

K1H8L6

Ottawa Hospital General Campus, Ottawa

M4N 3M5

Sunnybrook Odette Cancer Centre, Toronto

H1T 2M4

Hopital Maisonneuve-Rosemont, Montreal

H2L 4M1

Centre Hospitalier de l'Université de Montréal pavilion Notre Dame, Montreal

H4J 1C5

Hopital du Sacre Coeur de Montréal, Montreal

T2N 2T9

Tom Baker Cancer Centre, Calgary

M5G 2M9

Princess Margaret Hospital, Ontario

625 00

Fakultni nemocnice Brno, Brno

775 20

Fakultni nemocnice Olomouc, hemato-onkologicka klinika, Olomouc

128 08

Vseobecna Fakultni Nemocnice v Praze, Prague

128 20

Ustav hematologie a krevni transfuze, Prague

06202

Centre Hospitalier Universitaire de Nice, Nice

04103

Universitätsklinikum Leipzig, Leipzig

07747

Universitätsklinikum Jena, Jena

00161

Azienda Policlinico Umberto I di Roma, Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

9700 RB

Universitair Medisch Centrum Groningen, Groningen

50-367

Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroclaw

53-439

Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wroclaw

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

40-032

Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice

93-510

Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika, Lódz

410 028

Saratov State Medical University, Saratov

135-710

Samsung Medical Center, Gangnam-gu

110-774

Seoul National University Hospital, Jongno-gu

120-752

Yonsei University Health System, Seodaemun-gu

700-721

Kyungpook National University Hospital, Daegu

137-701

Seoul Saint Mary's Hospital Seocho-gu, Seoul

138-736

Asan Medical Center, Seoul

152-703

Korea University Hospital at Guro, Seoul

07014

Hospital Son Dureta, Palma de Mallorca

07198

Hospital Son Llàtzer, Palma de Mallorca

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

SM2 5PT

Royal Marsden Hospital, Sutton

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

EC1A 7BE

Barts and the London NHS Trust, London

SE5 9RS

King's College Hospital, London

M13 9WL

Manchester Royal Infirmary, Manchester

OX3 9DS

Churchill Hospital, Oxford

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY