Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,106

Participants

Timeline

Start Date

June 30, 2000

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Chronic Myelogenous Leukemia
Interventions
DRUG

imatinib mesilate

imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules.

DRUG

interferon-alpha (INF-a)

interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day.

DRUG

cytarabine (ARA-C)

cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.

Trial Locations (163)

27

Novartis Investigative Site, Oslo

1000

Novartis Investigative Site, Brussels

1090

Novartis Investigative Site, Vienna

1200

Novartis Investigative Site, Brussels

2050

Novartis Investigative Site, Sydney

2730

Novartis Investigative Site, Herlev

3000

Novartis Investigative Site, Leuven

3010

Novartis Investigative Site, Bern

4031

Novartis Investigative Site, Basel

8000

Novartis Investigative Site, Aarhus

8025

Novartis Investigative Site, Barcelona

8036

Novartis Investigative Site, Barcelona

8907

Novartis Investigative Site, Barcelona

9007

Novartis Investigative Site, Sankt Gallen

9038

Novartis Investigative Site, Tromsø

10017

Novartis Investigative Site, New York

10021

Novartis Investigative Site, New York

10029

Novartis Investigative Site, New York

10043

Novartis Investigative Site, Orbassano

13210

Novartis Investigative Site, Syracuse

13273

Novartis Investigative Site, Marseille

13353

Novartis Investigative Site, Berlin

14263

Novartis Investigative Site, Buffalo

15224

Novartis Investigative Site, Pittsburgh

15232

Novartis Investigative Site, Pittsburgh

16132

Novartis Investigative Site, Genova

18057

Novartis Investigative Site, Rostock

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

21201

Novartis Investigative Site, Baltimore

27100

Novartis Investigative Site, Pavia

27157

Novartis Investigative Site, Winston-Salem

27599

Novartis Investigative Site, Chapel Hill

27710

Novartis Investigative Site, Durham

28034

Novartis Investigative Site, Madrid

28203

Novartis Investigative Site, Charlotte

28222

Novartis Investigative Site, Madrid

29303

Novartis Investigative Site, Spartanburg

30342

Novartis Investigative Site, Atlanta

32804

Novartis Investigative Site, Orlando

33604

Novartis Investigative Site, Pessac

35037

Novartis Investigative Site, Marburg

35294

Novartis Investigative Site, Birmingham

36106

Novartis Investigative Site, Montgomery

37007

Novartis Investigative Site, Salamanca

37203

Novartis Investigative Site, Nashville

37205

Novartis Investigative Site, Nashville

38119

Novartis Investigative Site, Memphis

40138

Novartis Investigative Site, Bologna

40202

Novartis Investigative Site, Louisville

40225

Novartis Investigative Site, Düsseldorf

43210

Novartis Investigative Site, Columbus

43215

Novartis Investigative Site, Columbus

44035

Novartis Investigative Site, Nantes

44195

Novartis Investigative Site, Cleveland

45429

Novartis Investigative Site, Dayton

46010

Novartis Investigative Site, Madrid

Novartis Investigative Site, Valencia

46107

Novartis Investigative Site, Beech Grove

48109

Novartis Investigative Site, Ann Arbor

48910

Novartis Investigative Site, East Lansing

50134

Novartis Investigative Site, Florence

53215

Novartis Investigative Site, Milwaukee

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55101

Novartis Investigative Site, Mainz

55455

Novartis Investigative Site, Minneapolis

56126

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

59101

Novartis Investigative Site, Billings

60590

Novartis Investigative Site, Frankfurt

60611

Novartis Investigative Site, Chicago

60612

Novartis Investigative Site, Chicago

60637

Novartis Investigative Site, Chicago

62526

Novartis Investigative Site, Decatur

63110

Novartis Investigative Site, St Louis

65124

Novartis Investigative Site, Pescara

67098

Novartis Investigative Site, Strasbourg

67214

Novartis Investigative Site, Witchita

68189

Novartis Investigative Site, Mannheim

69115

Novartis Investigative Site, Heidelberg

69437

Novartis Investigative Site, Lyon

70112

Novartis Investigative Site, New Orleans

70124

Novartis Investigative Site, Bari

70376

Novartis Investigative Site, Stuttgart

74136

Novartis Investigative Site, Tulsa

75246

Novartis Investigative Site, Dallas

75475

Novartis Investigative Site, Paris

77030

Novartis Investigative Site, Houston

79106

Novartis Investigative Site, Freiburg im Breisgau

80131

Novartis Investigative Site, Napoli

80218

Novartis Investigative Site, Denver

80804

Novartis Investigative Site, München

81675

Novartis Investigative Site, München

84112

Novartis Investigative Site, Salt Lake City

85724

Novartis Investigative Site, Tucson

87109

Novartis Investigative Site, Albuquerque

87131

Novartis Investigative Site, Albuquerque

Novartis Investigative Site, Farmington

89123

Novartis Investigative Site, Reggio Calabria

91010

Novartis Investigative Site, Duarte

93042

Novartis Investigative Site, Regensburg

94010

Novartis Investigative Site, Créteil

94704

Novartis Investigative Site, Berkeley

95008

Novartis Investigative Site, Campbell

96813

Novartis Investigative Site, Honolulu

97239

Novartis Investigative Site, Portland

92093-0960

Novartis Investigative Site, La Jolla

33176-2197

Novartis Investigative Site, Miami

02115

Novartis Investigative Site, Boston

01665

Novartis Investigative Site, Worcester

48202-2689

Novartis Investigative Site, Detroit

68198-7681

Novartis Investigative Site, Omaha

07601

Novartis Investigative Site, Hackensack

02903

Novartis Investigative Site, Providence

75235-9179

Novartis Investigative Site, Dallas

98109-1024

Novartis Investigative Site, Seattle

Unknown

Novartis Investigative Site, Adelaide

Novartis Investigative Site, Brisbane

Novartis Investigative Site, Darlinghurst

Novartis Investigative Site, East Melbourne

Novartis Investigative Site, Nedlands

Novartis Investigative Site, Parkville

Novartis Investigative Site, Prahan

Novartis Investigative Site, South Brisbane

Novartis Investigative Site, St Leonards

Novartis Investigative Site, Westmead

Novartis Investigative Site, Godinne

Novartis Investigative Site, Copenhagen

Novartis Investigative Site, Poitiers

Novartis Investigative Site, Rotterdam

Novartis Investigative Site, Auckland

Novartis Investigative Site, Plymouth

T2N 4N2

Novartis Investigative Site, Calgary

T6G 1Z2

Novartis Investigative Site, Edmonton

V5Z 1M9

Novartis Investigative Site, Vancouver

R3E 0V9

Novartis Investigative Site, Winnipeg

B3H 2Y9

Novartis Investigative Site, Halifax

L8N 3Z5

Novartis Investigative Site, Hamilton

N6A 4G5

Novartis Investigative Site, London

K1H 8L6

Novartis Investigative Site, Ottawa

M5G 2M9

Novartis Investigative Site, Toronto

H1T 2M4

Novartis Investigative Site, Montreal

H3A 1A1

Novartis Investigative Site, Montreal

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

1081HV

Novartis Investigative Site, Amsterdam

143 45

Novartis Investigative Site, Gothenburg

581 85

Novartis Investigative Site, Linköping

221 85

Novartis Investigative Site, Lund

70 185

Novartis Investigative Site, Örebro

141 86

Novartis Investigative Site, Stockholm

171 76

Novartis Investigative Site, Stockholm

901 85

Novartis Investigative Site, Umeå

751 85

Novartis Investigative Site, Uppsala

B9 5SS

Novartis Investigative Site, Birmingham

CB2 2XY

Novartis Investigative Site, Cambridge

CF14 4XN

Novartis Investigative Site, Cardiff

LS1 3EX

Novartis Investigative Site, Leeds

L7 8XP

Novartis Investigative Site, Liverpool

EC1A 7BE

Novartis Investigative Site, London

SE5 9RS

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY