coiaward2010

CABL001A2301 = ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, South America]

Study title

Study of efficacy of CML-CP patients treated with ABL001 versus bosutinib, previously treated with 2 or more tyrosine kinase inhibitors

Scientific title

A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors (EudraCT number 2016-002461-66, ClinicalTrials.gov NCT03106779)

Indication and most important inclusion criteria

Male or female patients 18 years and older with CML-CP, previously treated with at least two tyrosine kinase inhibitors (TKI). Patients can be considered for inclusion in the study if they have not responded or are intolerant to the last TKI therapy as shown by BCR-ABL results of 1% or more on the international scale (IS) at the screening examination.

Short description of intervention

The purpose of this study is to compare the efficacy of ABL001 (asciminib) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with at least two tyrosine kinase inhibitors.
In this study, patients will be given either asciminib 40 mg twice daily or bosutinib 500 mg once daily.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

To be completed

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Argentina

Novartis Investigative Site
Caba, Buenos Aires, C1221ADH

Novartis Investigative Site
La Plata, Buenos Aires, B1900AWT

Novartis Investigative Site
Capital Federal, C1114AAN


Australia

South Australia
Novartis Investigative Site
Adelaide, South Australia, 5000

Victoria
Novartis Investigative Site
Melbourne, 3000

Western Australia
Novartis Investigative Site
Murdoch, 6150

Belgium

Novartis Investigative Site
Brugge, 8000

Novartis Investigative Site
Leuven, 3000


Brazil

Novartis Investigative Site
Porto Alegre, 90035-003

Novartis Investigative Site
Rio de Janeiro, RJ, 20.211-030

Novartis Investigative Site
Sao Paulo, SP, 05403 000

Novartis Investigative Site
Sao Paulo, SP, 08270-070

 

Bulgaria

Novartis Investigative Site
Pleven, 5800

Novartis Investigative Site
Plovdiv, 4002


Canada

Ontario
Novartis Investigative Site
Toronto, Ontario, M5G 2M9

Quebec
Novartis Investigative Site
Montreal, Quebec, H3T 1E2

Chech Republic

Novartis Investigative Site
Brno Bohunice, 625 00

Novartis Investigative Site
Hradec Kralove, 500 05

Novartis Investigative Site
Ostrava Poruba, 708 52

Novartis Investigative Site
Praha 2, 128 20


France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Lille Cedex, 59037

Novartis Investigative Site
Lyon Cedex, 69373

Novartis Investigative Site
Marseille, 13273

Novartis Investigative Site
Paris Cedex 10, 75475

Novartis Investigative Site
Vandoeuvre les Nancy, 54511


Germany

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Duesseldorf, 40225

Novartis Investigative Site
Frankfurt, 60590

Novartis Investigative Site
Hannover, 30625

Novartis Investigative Site
Heidelberg, 69120

Novartis Investigative Site
Jena, 07740

Novartis Investigative Site
Kiel, 24116

Novartis Investigative Site
Leipzig, 24116

Novartis Investigative Site
Mannheim, 68305

Novartis Investigative Site
Muenchen, 81675

Novartis Investigative Site
Nuernberg, 90419

 

Hungary

Novartis Investigative Site
Budapest, 1097

Novartis Investigative Site
Debrecen, 4032

Novartis Investigative Site
Kaposvar, 4032


Israel

Novartis Investigative Site
Haifa, 3525408

Novartis Investigative Site
Jerusalem, 91120

Novartis Investigative Site
Zifrin, 70300

 

Italy

Novartis Investigative Site
Bari, 70124

Novartis Investigative Site
Bologna, 40138

Novartis Investigative Site
Catania, 95124

Novartis Investigative Site
Milano, 20122

Novartis Investigative Site
Milano, 20162

Novartis Investigative Site
Napoli, 80132

Novartis Investigative Site
Roma, 00161

 

Japan

Novartis Investigative Site
Aomori, 030 8553

Novartis Investigative Site
Akita, 010-8543

Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8677

Novartis Investigative Site
Chuo-city, Yamanashi, 409-3898

Novartis Investigative Site
Fukuoka city, Fukuoka, 812-8582

Novartis Investigative Site
Kashiwa, Chiba, 277-8577

Novartis Investigative Site
Kobe-shi, Hyogo, 650-0017

Novartis Investigative Site
Nagoya, Aichi, 453-8511

Novartis Investigative Site
Sapporo-city, Hokkaido, 060-8648

Novartis Investigative Site
Sayama, Osaka, 589-8511

Novartis Investigative Site
Suita-city, Osaka, 565 0871

Novartis Investigative Site
Toyoake city, Aichi, 470 1192

Novartis Investigative Site
Yokohama city, Kanagawa, 232 0024

Korea, Republic of

Novartis Investigative Site
Seoul, 06591

Novartis Investigative Site
Busan, 49201


Lebanon

Novartis Investigative Site
Ashrafieh, 166830

Novartis Investigative Site
Beirut, 1107 2020

Novartis Investigative Site
Beirut, 1136044

Netherlands

Novartis Investigative Site
Amsterdam, 1081 HV

Novartis Investigative Site
Dordrecht, 3318AT


Russian Federation

Novartis Investigative Site
Moscow, 125167

Novartis Investigative Site
Moscow, 125284

Novartis Investigative Site
Saint Petersburg, 191024

Novartis Investigative Site
Saint Petersburg, 197341


Saudi Arabia

Novartis Investigative Site
Riyadh, 11211


Spain

Novartis Investigative Site
Barcelona, Catalunya, 08036

Novartis Investigative Site
Bilbao, Bizkaia, 48013

Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, 08907

Novartis Investigative Site
Madrid, 28006

Novartis Investigative Site
Madrid, 28034

Novartis Investigative Site
Malaga, Andalucia, 29010

Novartis Investigative Site
Toledo, Castilla La Mancha, 45071


Switzerland


Novartis Investigative Site
Zürich, 8091


Turkey

Novartis Investigative Site
Istanbul, 34098

Novartis Investigative Site
Istanbul, 34093


United Kingdom

Novartis Investigative Site
Cardiff, CF4 4XN

Novartis Investigative Site
Glasgow, Scotland, G12 0YN

Novartis Investigative Site
London, W12 0HS

Novartis Investigative Site
Merseyside, L7 8PX

Novartis Investigative Site
Oxford, OX3 7LJ


USA

Arizona
Mayo Clinic Arizona
Phoenix, Arizona, 85054

California
City of Hope
Duarte, California, 91010

Illinois
University of Chicago Hospital
Chicago, Chicago, 60637

Indiana
Indiana Blood and Marrow Institute Regulatory
Beech Grove, Indiana, 4610

Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205

Massachusetts
Dana Farber Cancer Center
Boston, Massachusetts, 02215

Michigan
University of Michigan Clinical Trials Office Main Site
Ann Arbor, Michigan, 48109

Missouri
Washington University School of Medicine
Saint Louis, Missouri, 63110

New Jersey
Hackensack University Medical Center John Theurer Cancer Center
Hackensack, New Jersey, 07601

New York
Roswell Park Cancer Institute
Buffalo, New York, 14263

Weill Cornell Medicine NewYork Presbyterian Hospital
New York, New York, 10021

Oregon
Oregon Health Sciences Univ Oregon Health Sciences Univ
Portland, Oregonk 97239

Texas
University of TX MD Anderson Cancer Center Primary
Houston, Texas, 77030

Utah
Utah Huntsman Cancer Center
Salt Lake City, Utah, 84112

Washington
Fred Hutchinson Cancer Center
Seattle, Washington, 98109

 


 
   
 

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