A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

PHASE3CompletedINTERVENTIONAL
Enrollment

846

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

September 2, 2009

Study Completion Date

August 21, 2019

Conditions
Myelogenous Leukemia, Chronic
Interventions
DRUG

nilotinib

Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.

DRUG

imatinib

Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).

Trial Locations (213)

1000

Novartis Investigative Site, Brussels

1010

Novartis Investigative Site, Caracas

1097

Novartis Investigative Site, Budapest

1205

Novartis Investigative Site, Geneva

2193

Novartis Investigative Site, Parktown

3000

Novartis Investigative Site, Leuven

5020

Novartis Investigative Site, Salzburg

5530

Novartis Investigative Site, Yvoir

6000

Novartis Investigative Site, Charleroi

7006

Novartis Investigative Site, Trondheim

7925

Novartis Investigative Site, Cape Town

9000

Novartis Investigative Site, Ghent

9301

Novartis Investigative Site, Bloemfontein

10002

Novartis Investigative Site, Taipei

10021

Memorial Sloan Kettering Cancer Center Clinical Trials Office, New York

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

13273

Novartis Investigative Site, Marseille

13353

Novartis Investigative Site, Berlin

14033

Novartis Investigative Site, Caen

15006

Novartis Investigative Site, A Coruña

15100

Novartis Investigative Site, Alessandria

15706

Novartis Investigative Site, Santiago de Compostela

16132

Novartis Investigative Site, Genova

18014

Novartis Investigative Site, Granada

20080

Novartis Investigative Site, Donostia / San Sebastian

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

27100

Novartis Investigative Site, Pavia

27157

Wake Forest University Health Sciences Dept. of Industry Research, Winston-Salem

27514

University of North Carolina UNC Lineberger Cancer Center, Chapel Hill

28006

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

29605

Cancer Centers of the Carolinas CC of C -Eastside, Greenville

31059

Novartis Investigative Site, Toulouse

32804

Florida Retina Institute Flordia Cancer Affilates, Orlando

33076

Novartis Investigative Site, Bordeaux

33100

Novartis Investigative Site, Udine

33176

Advanced Medical Specialties Research Dept., Miami

33305

Novartis Investigative Site, Taoyuan District

33901

Florida Cancer Specialists Dept. FloridaCancerSpecialists, Fort Myers

34098

Novartis Investigative Site, Istanbul

34761

Cancer Centers of Florida PA Cancer Centers of FL, Ocoee

35019

Novartis Investigative Site, Rennes

35340

Novartis Investigative Site, Izmir

37007

Novartis Investigative Site, Salamanca

37203

Tennessee Oncology Dept. of Centennial Medical, Nashville

37404

Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology, Chattanooga

38043

Novartis Investigative Site, Grenoble

38320

Novartis Investigative Site, San Cristóbal de La Laguna

39008

Novartis Investigative Site, Santander

40032

Novartis Investigative Site, Katowice

40138

Novartis Investigative Site, Bologna

40225

Novartis Investigative Site, Düsseldorf

41944

Novartis Investigative Site, Taegu

42270

Novartis Investigative Site, Saint Priest En Jarez

44035

Novartis Investigative Site, Nantes

44195

Cleveland Clinic Foundation CCF, Cleveland

45219

University of Cincinnati / Barrett Cancer Center Dept.of Internal Med., Cincinnati

46010

Novartis Investigative Site, Valencia

46107

Indiana Blood and Marrow Institute Dept. of Indiana Blood&Marrow, Beech Grove

48013

Novartis Investigative Site, Bilbao

48824

Michigan State University / Breslin Cancer Center Breslin Cancer Center, Lansing

49033

Novartis Investigative Site, Angers

50009

Novartis Investigative Site, Zaragoza

50134

Novartis Investigative Site, Florence

50937

Novartis Investigative Site, Cologne

52242

University of Iowa Hospitals and Clinics Dept.of U of Iowa Hosp&Clinics, Iowa City

53100

Novartis Investigative Site, Siena

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

56126

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

60126

Novartis Investigative Site, Ancona

60590

Novartis Investigative Site, Frankfurt

60637

University of Chicago Section of Hematology/Oncology, Chicago

63136

Hematology Oncology Consultants, Inc. Deptof Hem. Onc.Consunsultants, St Louis

64460

Novartis Investigative Site, Monterrey

65124

Novartis Investigative Site, Pescara

65201

Missouri Cancer Associates Dept. of Boone Hospital Center, Columbia

66210

Kansas City Cancer Center KCCC Business Office, Overland Park

68000

Novartis Investigative Site, Kuala Selangor

68305

Novartis Investigative Site, Mannheim

69495

Novartis Investigative Site, Pierre-Bénite

70115

LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center, New Orleans

75230

Texas Cancer Center ( Medical City Dallas Hospital), Dallas

75475

Novartis Investigative Site, Paris

75702

Tyler Cancer Center, Tyler

78229

Cancer Care Centers of South Texas HOAST CCC of So.TX- Medical Center, San Antonio

80131

Novartis Investigative Site, Napoli

80132

Novartis Investigative Site, Napoli

81675

Novartis Investigative Site, München

83301

Novartis Investigative Site, Kaohsiung City

84106

Utah Cancer Specialists, Salt Lake City

85107

Novartis Investigative Site, Bratislava

86000

Novartis Investigative Site, Poitiers

89081

Novartis Investigative Site, Ulm

89124

Novartis Investigative Site, Reggio Calabria

90095

University of California at Los Angeles Dept. of Hematology Clinic, Los Angeles

92120

Kaiser Permanente - California Southern Dept of Kaiser South 3, San Diego

94010

Novartis Investigative Site, Créteil

94589

Kaiser Permanente - California Northern Vallejo Med Center/Med Offices, Vallejo

94609

Kaiser Permanente - California Northern Kaiser Med, Vallejo

95123

Novartis Investigative Site, Catania

97210

Northwest Cancer Specialists Compass Oncology -BKM, Portland

99817

Novartis Investigative Site, Eisenach

110001

Novartis Investigative Site, Bogotá

110111

Novartis Investigative Site, Bogota

119228

Novartis Investigative Site, Singapore

125167

Novartis Investigative Site, Moscow

169608

Novartis Investigative Site, Singapore

197022

Novartis Investigative Site, Saint Petersburg

519763

Novartis Investigative Site, Jeollanam-do

630051

Novartis Investigative Site, Novosibirsk

Unknown

Rocky Mountain Cancer Centers RMCC - Colorado Springs, Greenwood Village

Novartis Investigative Site, Cairo

Novartis Investigative Site, Hong Kong

07601

Hackensack University Medical Center Department of Research, Hackensack

C1221ADC

Novartis Investigative Site, CABA

B1902AVG

Novartis Investigative Site, La Plata

A-1090

Novartis Investigative Site, Vienna

70330-150

Novartis Investigative Site, Brasília

80060-900

Novartis Investigative Site, Curitiba

20211-030

Novartis Investigative Site, Rio de Janeiro

13083-970

Novartis Investigative Site, Campinas

17210-080

Novartis Investigative Site, Jaú

01224-000

Novartis Investigative Site, São Paulo

01401-901

Novartis Investigative Site, São Paulo

05403 000

Novartis Investigative Site, São Paulo

V5Z 4E3

Novartis Investigative Site, Vancouver

V5Z 4E6

Novartis Investigative Site, Vancouver

M5G 2M9

Novartis Investigative Site, Toronto

G1J 1Z4

Novartis Investigative Site, Québec

G1R 2J6

Novartis Investigative Site, Québec

128 20

Novartis Investigative Site, Prague

775 20

Novartis Investigative Site, Olomouc

DK-2100

Novartis Investigative Site, Copenhagen

DK-7100

Novartis Investigative Site, Vejle

FIN-00029

Novartis Investigative Site, HUS Helsinki

FIN-20521

Novartis Investigative Site, Turku

06202

Novartis Investigative Site, Nice

04103

Novartis Investigative Site, Leipzig

00133

Novartis Investigative Site, Roma

00144

Novartis Investigative Site, Roma

00161

Novartis Investigative Site, Roma

06129

Novartis Investigative Site, Perugia

453-8511

Novartis Investigative Site, Nagoya

466 8560

Novartis Investigative Site, Nagoya

371 8511

Novartis Investigative Site, Maebashi

371-0821

Novartis Investigative Site, Maebashi

003-0006

Novartis Investigative Site, Sapporo

060 8648

Novartis Investigative Site, Sapporo

663 8501

Novartis Investigative Site, Nishinomiya

305-8576

Novartis Investigative Site, Tsukuba

920-8641

Novartis Investigative Site, Kanazawa

860-8556

Novartis Investigative Site, Kumamoto

514-8507

Novartis Investigative Site, Tsu

852-8501

Novartis Investigative Site, Nagasaki

589 8511

Novartis Investigative Site, Ōsaka-sayama

565 0871

Novartis Investigative Site, Suita

350-1298

Novartis Investigative Site, Hidaka

431-3192

Novartis Investigative Site, Hamamatsu

329-0498

Novartis Investigative Site, Shimotsuke

113 8655

Novartis Investigative Site, Bunkyo Ku

113-8519

Novartis Investigative Site, Bunkyo-ku

104 0045

Novartis Investigative Site, Chuo Ku

141 8625

Novartis Investigative Site, Shinagawa Ku

160 8582

Novartis Investigative Site, Shinjuku-ku

160-0023

Novartis Investigative Site, Shinjuku-ku

010-8543

Novartis Investigative Site, Akita

260 8677

Novartis Investigative Site, Chiba

734-8551

Novartis Investigative Site, Hiroshima

951 8520

Novartis Investigative Site, Niigata

545-8586

Novartis Investigative Site, Osaka

330 8503

Novartis Investigative Site, Saitama

06726

Novartis Investigative Site, Mexico City

1081 HV

Novartis Investigative Site, Amsterdam

NO-0310

Novartis Investigative Site, Oslo

20-081

Novartis Investigative Site, Lublin

35 055

Novartis Investigative Site, Rzeszów

02-097

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

833 10

Novartis Investigative Site, Bratislava

0001

Novartis Investigative Site, Pretoria

0027

Novartis Investigative Site, Pretoria

05505

Novartis Investigative Site, Seoul

06591

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

03203

Novartis Investigative Site, Elche

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

SE-413 45

Novartis Investigative Site, Gothenburg

SE-14186

Novartis Investigative Site, Huddinge

SE 971 80

Novartis Investigative Site, Luleå

SE-221 85

Novartis Investigative Site, Lund

SE-701 85

Novartis Investigative Site, Örebro

SE-171 76

Novartis Investigative Site, Stockholm

SE-851 86

Novartis Investigative Site, Sundsvall

SE-901 85

Novartis Investigative Site, Umeå

SE-751 85

Novartis Investigative Site, Uppsala

01330

Novartis Investigative Site, Adana

06500

Novartis Investigative Site, Ankara

G12 OYN

Novartis Investigative Site, Glasgow

LS9 7TF

Novartis Investigative Site, Leeds

L7 8XP

Novartis Investigative Site, Liverpool

W12 0HS

Novartis Investigative Site, London

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY