A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

568

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

May 15, 2025

Study Completion Date

July 7, 2031

Conditions
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Interventions
DRUG

Asciminib

Asciminib 80 mg QD administered under fasting conditions.

DRUG

Nilotinib

Nilotinib 300 mg BID administered under fasting conditions.

Trial Locations (120)

123

Novartis Investigative Site, Khoudh

1211

Novartis Investigative Site, Geneva

1431

Novartis Investigative Site, Sofia

1797

Novartis Investigative Site, Sofia

2013

Novartis Investigative Site, Soweto

3300

Novartis Investigative Site, Eger

4002

Novartis Investigative Site, Plovdiv

5800

Novartis Investigative Site, Pleven

9010

Novartis Investigative Site, Varna

10126

Novartis Investigative Site, Torino

11759

Novartis Investigative Site, Uijeongbu-si

11941

Novartis Investigative Site, Amman

13273

Novartis Investigative Site, Marseille

13353

Novartis Investigative Site, Berlin

13620

Novartis Investigative Site, Bundang Gu

14033

Novartis Investigative Site, Caen

15526

Novartis Investigative Site, Bad Saarow

20162

Novartis Investigative Site, Milan

20246

Novartis Investigative Site, Hamburg

23502

Virginia Oncology Associates, Norfolk

23538

Novartis Investigative Site, Lübeck

28205

Novartis Investigative Site, Bremen

28806

Messino Cancer Centers, Asheville

30161

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33076

Novartis Investigative Site, Bordeaux

33098

Novartis Investigative Site, Paderborn

34098

Novartis Investigative Site, Istanbul

35043

Novartis Investigative Site, Marburg

35100

Novartis Investigative Site, Izmir

39104

Novartis Investigative Site, Magdeburg

42551

Novartis Investigative Site, Velbert

44093

Novartis Investigative Site, Nantes

45147

Novartis Investigative Site, Essen

45242

Oncology Hematology Care Inc, Cincinnati

46150

Novartis Investigative Site, Petaling Jaya

47014

Novartis Investigative Site, Meldola

52074

Novartis Investigative Site, Aachen

53105

Novartis Investigative Site, Bonn

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

55101

Regions Hospital, Saint Paul

56126

Novartis Investigative Site, Pisa

59037

Novartis Investigative Site, Lille

59100

Novartis Investigative Site, Kuala Lumpur

60590

Novartis Investigative Site, Frankfurt am Main

61615

Illinois Cancer Care, Peoria

63003

Novartis Investigative Site, Clermont-Ferrand

67200

Novartis Investigative Site, Strasbourg

68305

Novartis Investigative Site, Mannheim

69120

Novartis Investigative Site, Heidelberg

69373

Novartis Investigative Site, Lyon

72076

Novartis Investigative Site, Tübingen

75475

Novartis Investigative Site, Paris

76022

Texas Oncology P A, Bedford

Texas Oncology PA Bedford, Bedford

79106

Novartis Investigative Site, Freiburg im Breisgau

80304

Rocky Mountain Cancer Centers, Boulder

80377

Novartis Investigative Site, München

81241

Novartis Investigative Site, Munich

86021

Novartis Investigative Site, Poitiers

86179

Novartis Investigative Site, Augsburg

89081

Novartis Investigative Site, Ulm

91054

Novartis Investigative Site, Erlangen

93049

Novartis Investigative Site, Regensburg

93586

Novartis Investigative Site, Kuching

95445

Novartis Investigative Site, Bayreuth

97080

Novartis Investigative Site, Würzburg

97401

Williamette Cancer Center, Eugene

110029

Novartis Investigative Site, New Delhi

119074

Novartis Investigative Site, Singapore

169608

Novartis Investigative Site, Singapore

200136

Novartis Investigative Site, Craiova

221010

Novartis Investigative Site, Varanasi

249203

Novartis Investigative Site, Rishikesh

300079

Novartis Investigative Site, Timișoara

380009

Novartis Investigative Site, Ahmedabad

400124

Novartis Investigative Site, Cluj-Napoca

540136

Novartis Investigative Site, Târgu Mureş

550245

Novartis Investigative Site, Sibiu

600036

Novartis Investigative Site, Chennai

C1181ACH

Novartis Investigative Site, CABA

C1221ADH

Novartis Investigative Site, CABA

C1039AAC

Novartis Investigative Site, Buenos Aires

C1114AAN

Novartis Investigative Site, Buenos Aires

C1425AUM

Novartis Investigative Site, Buenos Aires

N6A 5W9

Novartis Investigative Site, London

M5G 2M9

Novartis Investigative Site, Toronto

625 00

Novartis Investigative Site, Brno

301 00

Novartis Investigative Site, Plzen Bory

100 34

Novartis Investigative Site, Prague

128 00

Novartis Investigative Site, Prague

06202

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

04103

Novartis Investigative Site, Leipzig

06120

Novartis Investigative Site, Halle

07740

Novartis Investigative Site, Jena

09113

Novartis Investigative Site, Chemnitz

106 76

Novartis Investigative Site, Athens

115 27

Novartis Investigative Site, Athens

455 00

Novartis Investigative Site, Ioannina

265 04

Novartis Investigative Site, Pátrai

570 10

Novartis Investigative Site, Thessaloniki

H-1083

Novartis Investigative Site, Budapest

H-1097

Novartis Investigative Site, Budapest

00144

Novartis Investigative Site, Roma

05460

Novartis Investigative Site, Alor Star

3318 AT

Novartis Investigative Site, Dordrecht

021494

Novartis Investigative Site, Bucharest

022328

Novartis Investigative Site, Bucharest

030 171

Novartis Investigative Site, Bucharest

S308433

Novartis Investigative Site, Singapore

851 07

Novartis Investigative Site, Bratislava

0044

Novartis Investigative Site, Pretoria

06230

Novartis Investigative Site, Ankara

00000

Novartis Investigative Site, Abu Dhabi

G12 0YN

Novartis Investigative Site, Glasgow

GL1 3NN

Novartis Investigative Site, Gloucester

SE5 9RS

Novartis Investigative Site, London

W12 0HS

Novartis Investigative Site, London

NP20 2UB

Novartis Investigative Site, Newport

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY