NCT01061177View on ClinicalTrials.gov

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

PHASE4CompletedINTERVENTIONAL
Enrollment

1,090

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2014

Conditions
CML in Chronic Phase
Interventions
DRUG

Nilotinib

Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.

Trial Locations (320)

1000

Novartis Investigative Site, Brussels

Novartis Investigative Site, Ljubljana

1006

Novartis Investigative Site, Riga

1020

Novartis Investigative Site, Laken

1070

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Brussels

1097

Novartis Investigative Site, Budapest

1210

Novartis Investigative Site, Luxembourg

1211

Novartis Investigative Site, Geneva

1431

Novartis Investigative Site, Sofia

1756

Novartis Investigative Site, Sofia

2650

Novartis Investigative Site, Edegem

3000

Novartis Investigative Site, Leuven

Novartis Investigative Site, Celje

3007

Novartis Investigative Site, Kaunas

3010

Novartis Investigative Site, Bern

3400

Novartis Investigative Site, Cluj-Napoca

3500

Novartis Investigative Site, Hasselt

4002

Novartis Investigative Site, Plovdiv

4010

Novartis Investigative Site, Linz

4032

Novartis Investigative Site, Debrecen

4068

Novartis Investigative Site, Stavanger

4800

Novartis Investigative Site, Verviers

5020

Novartis Investigative Site, Salzburg

5530

Novartis Investigative Site, Yvoir

5800

Novartis Investigative Site, Pleven

6000

Novartis Investigative Site, Charleroi

7000

Novartis Investigative Site, Chur

7006

Novartis Investigative Site, Trondheim

7400

Novartis Investigative Site, Kaposvár

7624

Novartis Investigative Site, Pécs

8000

Novartis Investigative Site, Bruges

8036

Novartis Investigative Site, Graz

8091

Novartis Investigative Site, Zurich

8800

Novartis Investigative Site, Roeselare

9000

Novartis Investigative Site, Ghent

Novartis Investigative Site, Varna

9300

Novartis Investigative Site, Aalst

10000

Novartis Investigative Site, Zagreb

10003

Novartis Investigative Site, Troyes

10043

Novartis Investigative Site, Orbassano

10126

Novartis Investigative Site, Torino

10707

Novartis Investigative Site, Berlin

10709

Novartis Investigative Site, Berlin

11527

Novartis Investigative Site, Athens

12100

Novartis Investigative Site, Cuneo

13273

Novartis Investigative Site, Marseille

13353

Novartis Investigative Site, Berlin

13616

Novartis Investigative Site, Aix-en-Provence

13915

Novartis Investigative Site, Marseille

14000

Novartis Investigative Site, Caen

14195

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

15236

Novartis Investigative Site, Frankfurt (Oder)

16132

Novartis Investigative Site, Genova

17475

Novartis Investigative Site, Greifswald

18057

Novartis Investigative Site, Rostock

20080

Novartis Investigative Site, Donostia / San Sebastian

20122

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21034

Novartis Investigative Site, Dijon

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Novartis Investigative Site, Saint-Brieuc

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Novartis Investigative Site, Lübeck

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Novartis Investigative Site, Pavia

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Novartis Investigative Site, Madrid

28034

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Novartis Investigative Site, Majadahonda

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Novartis Investigative Site, Brest

30008

Novartis Investigative Site, Murcia

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Novartis Investigative Site, Hanover

30625

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31059

Novartis Investigative Site, Toulouse

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Novartis Investigative Site, Treviso

31134

Novartis Investigative Site, Hildesheim

32005

Novartis Investigative Site, Ourense

32657

Novartis Investigative Site, Lemgo

32900

Novartis Investigative Site, Nîmes

33006

Novartis Investigative Site, Oviedo

33076

Novartis Investigative Site, Bordeaux

33102

Novartis Investigative Site, Paderborn

33604

Novartis Investigative Site, Bielefeld

34119

Novartis Investigative Site, Kassel

34125

Novartis Investigative Site, Kassel

34295

Novartis Investigative Site, Montpellier

35010

Novartis Investigative Site, Las Palmas de Gran Canaria

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Novartis Investigative Site, Rennes

35039

Novartis Investigative Site, Marburg

35128

Novartis Investigative Site, Padua

35392

Novartis Investigative Site, Giessen

36043

Novartis Investigative Site, Fulda

37007

Novartis Investigative Site, Salamanca

37044

Novartis Investigative Site, Tours

38043

Novartis Investigative Site, Grenoble

38320

Novartis Investigative Site, San Cristóbal de La Laguna

38642

Novartis Investigative Site, Goslar

39008

Novartis Investigative Site, Santander

39104

Novartis Investigative Site, Magdeburg

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

41016

Novartis Investigative Site, Blois

41063

Novartis Investigative Site, Mönchengladbach

41100

Novartis Investigative Site, Modena

42123

Novartis Investigative Site, Reggio Emilia

42271

Novartis Investigative Site, Saint-Priest-en-Jarez

42551

Novartis Investigative Site, Velbert

43005

Novartis Investigative Site, Tarragona

44035

Novartis Investigative Site, Nantes

44100

Novartis Investigative Site, Cona

45071

Novartis Investigative Site, Toledo

45136

Novartis Investigative Site, Essen

45147

Novartis Investigative Site, Essen

45468

Novartis Investigative Site, Mülheim

Novartis Investigative Site, Viersen

46010

Novartis Investigative Site, Valencia

46236

Novartis Investigative Site, Bottrop

47166

Novartis Investigative Site, Duisburg

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Novartis Investigative Site, Moers

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Novartis Investigative Site, Bilbao

48100

Novartis Investigative Site, Ravenna

48149

Novartis Investigative Site, Münster

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Novartis Investigative Site, Barakaldo

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Novartis Investigative Site, Angers

50009

Novartis Investigative Site, Zaragoza

50134

Novartis Investigative Site, Florence

50937

Novartis Investigative Site, Cologne

51000

Novartis Investigative Site, Rijeka

51006

Novartis Investigative Site, Tartu

51092

Novartis Investigative Site, Reims

52074

Novartis Investigative Site, Aachen

52249

Novartis Investigative Site, Eschweiler

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Novartis Investigative Site, Siena

53105

Novartis Investigative Site, Bonn

55131

Novartis Investigative Site, Mainz

56068

Novartis Investigative Site, Koblenz

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Novartis Investigative Site, Pisa

57038

Novartis Investigative Site, Metz

57124

Novartis Investigative Site, Livorno

58097

Novartis Investigative Site, Hagen

59020

Novartis Investigative Site, Lille

59063

Novartis Investigative Site, Hamm

59100

Novartis Investigative Site, Roubaix

59240

Novartis Investigative Site, Dunkirk

60126

Novartis Investigative Site, Ancona

60321

Novartis Investigative Site, Compiègne

60590

Novartis Investigative Site, Frankfurt

60596

Novartis Investigative Site, Frankfurt

61100

Novartis Investigative Site, Pesaro

62307

Novartis Investigative Site, Lens

63003

Novartis Investigative Site, Clermont-Ferrand

63739

Novartis Investigative Site, Aschaffenburg

64000

Novartis Investigative Site, Pau

64109

Novartis Investigative Site, Bayonne

65124

Novartis Investigative Site, Pescara

66046

Novartis Investigative Site, Perpignan

66538

Novartis Investigative Site, Neunkirchen

67085

Novartis Investigative Site, Strasbourg

67091

Novartis Investigative Site, Strasbourg

68070

Novartis Investigative Site, Mulhouse

68100

Novartis Investigative Site, Alexandroupoli

68169

Novartis Investigative Site, Mannheim

70124

Novartis Investigative Site, Bari

70376

Novartis Investigative Site, Stuttgart

71013

Novartis Investigative Site, San Giovanni Rotondo

71018

Novartis Investigative Site, Mâcon

71065

Novartis Investigative Site, Sindelfingen

71321

Novartis Investigative Site, Chalon-sur-Saône

72037

Novartis Investigative Site, Le Mans

72100

Novartis Investigative Site, Brindisi

73011

Novartis Investigative Site, Chambéry

73100

Novartis Investigative Site, Lecce

73240

Novartis Investigative Site, Wendlingen

73557

Novartis Investigative Site, Mutlangen

73614

Novartis Investigative Site, Schorndorf

74100

Novartis Investigative Site, Taranto

74374

Novartis Investigative Site, Pringy

74523

Novartis Investigative Site, Schwäbisch Hall

75012

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

76038

Novartis Investigative Site, Rouen

76133

Novartis Investigative Site, Karlsruhe

76135

Novartis Investigative Site, Karlsruhe

77652

Novartis Investigative Site, Offenburg

78098

Novartis Investigative Site, Triberg

78157

Novartis Investigative Site, Le Chesnay

79106

Novartis Investigative Site, Freiburg im Breisgau

80054

Novartis Investigative Site, Amiens Cedex1

80131

Novartis Investigative Site, Napoli

80132

Novartis Investigative Site, Napoli

80335

Novartis Investigative Site, München

81241

Novartis Investigative Site, München

81675

Novartis Investigative Site, München

81737

Novartis Investigative Site, München

82211

Novartis Investigative Site, Herrsching am Ammersee

82362

Novartis Investigative Site, Weilheim

83100

Novartis Investigative Site, Avellino

83278

Novartis Investigative Site, Traunstein

84014

Novartis Investigative Site, Nocera Inferiore

84028

Novartis Investigative Site, Landshut

84902

Novartis Investigative Site, Avignon

85100

Novartis Investigative Site, Potenza

85925

Novartis Investigative Site, La Roche-sur-Yon

86156

Novartis Investigative Site, Augsburg

87042

Novartis Investigative Site, Limoges

87067

Novartis Investigative Site, Rossano

88100

Novartis Investigative Site, Catanzaro

88214

Novartis Investigative Site, Ravensburg

89081

Novartis Investigative Site, Ulm

89124

Novartis Investigative Site, Reggio Calabria

90146

Novartis Investigative Site, Palermo

90419

Novartis Investigative Site, Nuremberg

90449

Novartis Investigative Site, Nuremberg

91100

Novartis Investigative Site, Corbeil-Essonnes

93370

Novartis Investigative Site, Montfermeil

94010

Novartis Investigative Site, Créteil

95107

Novartis Investigative Site, Argenteuil

95445

Novartis Investigative Site, Bayreuth

96049

Novartis Investigative Site, Bamberg

97080

Novartis Investigative Site, Würzburg

97405

Novartis Investigative Site, Saint-Denis

98012

Novartis Investigative Site, Monte-Carlo

98544

Novartis Investigative Site, Zella-Mehlis

99817

Novartis Investigative Site, Eisenach

700111

Novartis Investigative Site, Iași

900114

Novartis Investigative Site, Oulu

4200319

Novartis Investigative Site, Porto

A-4600

Novartis Investigative Site, Wels

A-6020

Novartis Investigative Site, Innsbruck

A-6830

Novartis Investigative Site, Rankweil

A-1130

Novartis Investigative Site, Vienna

A-1140

Novartis Investigative Site, Vienna

BE-B-1200

Novartis Investigative Site, Brussels

625 00

Novartis Investigative Site, Brno - Bohunice

500 05

Novartis Investigative Site, Hradec Králové

128 20

Novartis Investigative Site, Prague

775 20

Novartis Investigative Site, Olomouc

DK-8000

Novartis Investigative Site, Aarhus C

DK-2100

Novartis Investigative Site, Copenhagen

DK-5000

Novartis Investigative Site, Odense C

FIN-00029

Novartis Investigative Site, HUS Helsinki

06189

Novartis Investigative Site, Nice

02321

Novartis Investigative Site, Saint-Quentin

01307

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

711 10

Novartis Investigative Site, Heraklion Crete

265 00

Novartis Investigative Site, Pátrai

115 27

Novartis Investigative Site, Athens

411 10

Novartis Investigative Site, Larissa

546 42

Novartis Investigative Site, Thessaloniki

H-6725

Novartis Investigative Site, Szeged

09121

Novartis Investigative Site, Cagliari

09126

Novartis Investigative Site, Cagliari

00168

Novartis Investigative Site, Rome

08100

Novartis Investigative Site, Nuoro

00144

Novartis Investigative Site, Roma

00161

Novartis Investigative Site, Roma

07100

Novartis Investigative Site, Sassari

05100

Novartis Investigative Site, Terni

01100

Novartis Investigative Site, Ronciglione

06129

Novartis Investigative Site, Perugia

LT-92231

Novartis Investigative Site, Klaipėda

LT-08661

Novartis Investigative Site, Vilnius

1081 HV

Novartis Investigative Site, Amsterdam

2625 AD

Novartis Investigative Site, Delft

7513 ER

Novartis Investigative Site, Enschede

9713 GZ

Novartis Investigative Site, Groningen

6525 GA

Novartis Investigative Site, Nijmegen

3075 EA

Novartis Investigative Site, Rotterdam

8025 AB

Novartis Investigative Site, Zwolle

NO-5021

Novartis Investigative Site, Bergen

NO-0310

Novartis Investigative Site, Oslo

NO-9038

Novartis Investigative Site, Tromsø

02-106

Novartis Investigative Site, Warsaw

80-952

Novartis Investigative Site, Gdansk

30-510

Novartis Investigative Site, Krakow

20-081

Novartis Investigative Site, Lublin

02-776

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

1150-314

Novartis Investigative Site, Lisbon

4200-072

Novartis Investigative Site, Porto

022328

Novartis Investigative Site, Bucharest

030171

Novartis Investigative Site, Bucharest

300 079

Novartis Investigative Site, Timișoara

050098

Novartis Investigative Site, Bucharest

04066

Novartis Investigative Site, Košice

03601

Novartis Investigative Site, Martin

851 07

Novartis Investigative Site, Bratislava

03203

Novartis Investigative Site, Elche

08041

Novartis Investigative Site, Barcelona

08916

Novartis Investigative Site, Badalona

08003

Novartis Investigative Site, Barcelona

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08221

Novartis Investigative Site, Terrassa

SE-413 45

Novartis Investigative Site, Gothenburg

SE-14186

Novartis Investigative Site, Huddinge

SE-581 85

Novartis Investigative Site, Linköping

SE-971 80

Novartis Investigative Site, Luleå

SE-221 85

Novartis Investigative Site, Lund

SE-171 76

Novartis Investigative Site, Stockholm

SE-901 85

Novartis Investigative Site, Umeå

SE-751 85

Novartis Investigative Site, Uppsala

UB8 3NN

Novartis Investigative Site, Uxbridge

CF14 4XW

Novartis Investigative Site, Cardiff

DY1 2HQ

Novartis Investigative Site, Dudley

SE5 9RS

Novartis Investigative Site, London

W12 0HS

Novartis Investigative Site, London

NG5

Novartis Investigative Site, Nottingham

OX3 7LJ

Novartis Investigative Site, Oxford

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