Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission

PHASE3CompletedINTERVENTIONAL
Enrollment

472

Participants

Timeline

Start Date

April 24, 2013

Primary Completion Date

July 15, 2019

Study Completion Date

June 18, 2024

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Oral Azacitidine

300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.

DRUG

Placebo

Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.

Trial Locations (223)

24

Local Institution - 950, Dublin

133

Local Institution - 722, Rome

290

Local Institution - 361, Helsinki

404

Local Institution - 596, Taichung, Northern Dist.

704

Local Institution - 597, Tainan, Taiana

1130

Local Institution - 274, Vienna

1140

Local Institution - 272, Vienna

1190

Local Institution - 273, Vienna

2065

Local Institution - 506, St Leonards

2170

Local Institution - 507, Liverpool

2500

Local Institution - 510, Wollongong

3004

Local Institution - 500, Melbourne

3084

Local Institution - 503, Heidelberg

4101

Local Institution - 509, South Brisbane

4102

Local Institution - 501, Woolloongabba

4200

Local Institution - 844, Porto

5011

Local Institution - 504, Woodville South

5020

Local Institution - 270, Salzburg

5042

Local Institution - 511, Bedford Park

5809

Local Institution - 750, Klaipėda

6000

Local Institution - 505, Perth

Local Institution - 512, Perth

Local Institution - 301, Charleroi

7000

Local Institution - 502, Hobart

Local Institution - 302, Mons

8000

Local Institution - 300, Bruges

8916

Local Institution - 869, Badalona (Barcelona)

10002

Local Institution - 598, Taipei, Zhongzheng Dist.

10003

Local Institution - 873, Cáceres

10029

Local Institution - 009, New York

10032

Columbia University Irving Medical Center, New York

10043

Local Institution - 705, Orbassano (TO)

10065

Local Institution - 002, New York

10126

Local Institution - 715, Torino

Local Institution - 718, Torino

10595

Local Institution - 014, Valhalla

11217

Local Institution - 599, Beitou District, Taipei City

12203

Local Institution - 413, Berlin

14004

Local Institution - 863, Córdoba

14080

Local Institution - 251, México

14642

Local Institution - 004, Rochester

15006

Local Institution - 867, A Coruña

15121

Local Institution - 701, Alessandria

15232

UPMC Cancer Pavillion, Pittsburgh

16132

Local Institution - 712, Genova

17604

Lancaster General Hospital, Lancaster

20037

George Washington University Cancer Center, Washington D.C.

20122

Local Institution - 706, Milan

20162

Local Institution - 726, Milan

20521

Local Institution - 360, Turku

20900

Local Institution - 704, Monza

21100

Local Institution - 707, Varese

24105

Local Institution - 403, Keil

26100

Local Institution - 702, Cremona

26133

Local Institution - 407, Oldenburg

27157

Local Institution - 025, Winston-Salem

27705

Duke University Medical Center, Durham

28006

Local Institution - 868, Madrid

28007

Local Institution - 866, Madrid

28040

Local Institution - 865, Madrid

29605

Greenville Hospital System, Greenville

30625

Local Institution - 405, Hanover

31122

Local Institution - 724, Pesaro

32610

Local Institution - 046, Gainesville

32806

Local Institution - 044, Orlando

33006

Local Institution - 864, Oviedo

33100

Local Institution - 711, Udine

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

33521

Local Institution - 362, Tampere

34662

Local Institution - 651, Istanbul

35254

Local Institution - 380, Haifa

37007

Local Institution - 861, Salamanca

37203

Local Institution - 011, Nashville

40138

Local Institution - 720, Bologna

40202

Local Institution - 049, Louisville

40207

Local Institution - 058, Louisville

40225

Local Institution - 406, Düsseldorf

41013

Local Institution - 862, Seville

44106

Local Institution - 016, Cleveland

46026

Local Institution - 860, Valencia

46237

Franciscan St. Francis Health, Indianapolis

47574

Local Institution - 412, Goch

49100

Local Institution - 382, Petah Tikva

49241

Local Institution - 535, Busan

50129

Local Institution - 708, Florence

52249

Local Institution - 416, Schweiler

52763

Local Institution - 252, Huixquilucan de Degollado

53127

Local Institution - 410, Bonn

55139

Local Institution - 652, Samsun

55905

Local Institution - 037, Rochester

59037

Local Institution - 453, Lille

60153

Loyola University Chicago, Maywood

60611

Northwestern University Medical Center, Chicago

60714

Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL, Niles

62200

Local Institution - 462, Boulognes Sur Mer

63110

Washington University School Of Medicine, St Louis

64128

Local Institution - 023, Kansas City

64460

Local Institution - 250, Monterrey

65929

Local Institution - 404, Frankfurt am Main

66205

Local Institution - 003, Westwood

68167

Local Institution - 402, Mannheim

69437

Local Institution - 450, Lyon

70112

Local Institution - 047, New Orleans

70124

Local Institution - 721, Bari

73013

Local Institution - 271, Graz

73100

Local Institution - 716, Lecce

73104

University of Oklahoma Peggy and Charles Stephenson Cancer Center, Oklahoma City

74078

Local Institution - 408, Heilbronn

75015

Local Institution - 463, Paris

75475

Local Institution - 454, Paris

Local Institution - 800, Paris

76038

Local Institution - 455, Rouen

77030

Local Institution - 001, Houston

78157

Local Institution - 458, Le Chesnay

78217

Cancer Care Centers of South Texas - Loop, San Antonio

78229

Local Institution - 039, San Antonio

78234

Local Institution - 034, Fort Sam Houston

80054

Local Institution - 456, Amiens

80131

Local Institution - 717, Naples

Local Institution - 725, Naples

80804

Local Institution - 409, München

81675

Local Institution - 411, München

83301

Local Institution - 595, Niaosong District Kaohsiung City

84101

Local Institution - 381, Beersheba

85016

Arizona Oncology Associates, P.C., Phoenix

87042

Local Institution - 461, Limoges

89081

Local Institution - 401, Ulm

89100

Local Institution - 700, Reggio Calabria

90033

University of Southern California Norris Cancer Center, Los Angeles

90146

Local Institution - 703, Palermo

Local Institution - 719, Palermo

90603

Innovative Clinical Research Institute, Whittier

91054

Local Institution - 415, Erlangen

91120

Local Institution - 383, Jerusalem

91505

Providence St Joseph Medical Center Cancer Center, Burbank

92123

Sharp Memorial Hospital, San Diego

92141

Local Institution - 460, Clamart

92210

Local Institution - 459, Saint-Cloud

92868

Local Institution - 050, Orange

93009

Local Institution - 457, Bobigny

93701

University of California San Francisco Fresno Campus, Fresno

94010

Local Institution - 452, Créteil

94305

Stanford Cancer Center, Stanford

94805

Local Institution - 451, Villejuif

95100

Local Institution - 465, Argenteuil

95301

Local Institution - 464, Pontoise

97227

Kaiser Permanente Northwest Oncology Hematology, Portland

98104

Swedish Cancer Inst, Seattle

98902

Yakima Valley Memorial Hospital/ North Star Lodge, Yakima

125101

Local Institution - 971, Moscow

196022

Local Institution - 972, Saint Petersburg

197341

Local Institution - 973, Saint Petersburg

603005

Local Institution - 970, Nizhny Novgorod

91010-301

City Of Hope, Duarte

90095-6956

Local Institution - 006, Los Angeles

80218-1210

Rocky Mountain Cancer Center, Denver

06489

Local Institution - 010, Southington

46202-528

Local Institution - 013, Indianapolis

70121-2483

Ochsner Medical Center - Jefferson Highway, New Orleans

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01655

Local Institution - 015, Worcester

68198-7680

Local Institution - 057, Omaha

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

08901

Cancer Institute of New Jersey, New Brunswick

11501-3893

Winthrop University Hospital, Mineola

37232-5505

Local Institution - 007, Nashville

75390-9068

Local Institution - 041, Dallas

23298-0037

Local Institution - 035, Richmond

53226-3522

Froedtert Hospital BMT Medical College of Wisconsin, Milwaukee

SA 5000

Local Institution - 508, Adelaide

81520-060

Local Institution - 233, Curitiba

90035-903

Local Institution - 231, Porto Alegre

20230-130

Local Institution - 232, Rio de Janeiro

01308-050

Local Institution - 234, São Paulo

05651-901

Local Institution - 230, São Paulo

T6G 2B7

Local Institution - 605, Edmonton

R3E OV9

Local Institution - 600, Winnipeg

E2L 4L2

Local Institution - 601, Saint John

A1B3V6

Local Institution - 603, St. John's

B3H 2Y9

Local Institution - 604, Halifax

M5G 2M9

Local Institution - 607, Toronto

H2W 1S6

Local Institution - 608, Montreal

H4J 1C5

Local Institution - 602, Montreal

625 00

Local Institution - 320, Brno

128 08

Local Institution - 321, Prague

128 20

Local Institution - 322, Prague

01307

Local Institution - 400, Dresden

07740

Local Institution - 414, Jena

ST46QG

Local Institution - 951, Galway

O9126

Local Institution - 710, Cagliari

00161

Local Institution - 709, Roma

00168

Local Institution - 714, Roma

00189

Local Institution - 723, Roma

85-168

Local Institution - 824, Bydgoszcz

80-211

Local Institution - 820, Gdansk

93-510

Local Institution - 822, Lodz

02-776

Local Institution - 821, Warsaw

50-367

Local Institution - 823, Wroclaw

4200-072

Local Institution - 841, Coimbra

Local Institution - 842, Porto

1099-023

Local Institution - 840, Lisbon

1150-314

Local Institution - 843, Lisbon

700-721

Local Institution - 533, Daegu

120-752

Local Institution - 536, Seoul

135-710

Local Institution - 530, Seoul

137-701

Local Institution - 531, Seoul

138-736

Local Institution - 532, Seoul

07198

Local Institution - 872, Palma de Mallorca

08025

Local Institution - 871, Barcelona

08035

Local Institution - 870, Barcelona

06100

Local Institution - 653, Ankara

06200

Local Institution - 650, Ankara

NG5 1PB

Local Institution - 904, Nottingham

PE21 9QS

Local Institution - 907, Boston

BN2 5BE

Local Institution - 903, Brighton East Sussex

CT1 3NG

Local Institution - 902, Canterbury Kent

NW1 2PG

Local Institution - 905, London

SE5 9RS

Local Institution - 901, London

W12 0HS

Local Institution - 908, London

ME16 9QQ

Local Institution - 909, Maidstone

M20 4BX

Local Institution - 900, Manchester

RM7 0AG

Local Institution - 906, Romford, Essex

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY