CABL001A2001B = Asciminib Roll-over Study [Asia-Pacific, Europe, Middle East, Central America, North America, South America]

What is the purpose of the study

This is a study to assess long term safety in patients who have completed an asciminib study sponsored by Novartis (a so-called parent study) and who, in the opinion of the investigator, would benefit from continued treatment or from switching to asciminib, but are unable to get this treatment outside of the clinical study.

What will happen during the study

Eligible patients who have completed a study on asciminib will either continue treatment as in the parent study or switch to asciminib (if they were on bosutinib in the parent study).

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older
• have Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML) or Philadelphia chromosome positive acute lymphoid leukemia (PH+ ALL)
• are currently receiving asciminib (alone or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a study sponsored by Novartis
• in the opinion of the Investigator, would benefit from continued treatment.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have been discontinued from treatment in the parent study
• have ongoing unwanted effects that are possibly related to study treatment in the parent study
• are receiving treatment that is currently approved and reimbursed in their country
• are pregnant or breast-feeding.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in the EU Clinical Trials Registry. This is a database hosted by the European Medicines Agency (EMA).

Study centers / principal investigators

Argentina

Novartis Investigative Site
Caba, Buenos Aires, C1221ADC

Austria

Novartis Investigative Site
Wien, 1140

Brazil

Novartis Investigative Site
Rio de Janeiro, 20211-030

Novartis Investigative Site
Sao Paulo, 05403-000

Novartis Investigative Site
Sao Paulo, 08270-000

Bulgaria

Novartis Investigative Site
Varna, 9010

Canada

Novartis Investigative Site
Montreal, Quebec, H1T 2M4

Czechia

Novartis Investigative Site
Brno Bohunice, 639 00

Novartis Investigative Site
Ostrava, Poruba, 708 52

Denmark

Novartis Investigative Site
Copenhagen, 2100

France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Marseille, 13273

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Paris Cedex 10, 75475

Novartis Investigative Site
Vandoeuvre les Nancy cedex, 54511

Germany

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Frankfurt, 60590

Novartis Investigative Site
Jena, 07743

Italy

Novartis Investigative Site
Milano, 20162

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site
Napoli, 80132

Japan

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

Korea, Republic of

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759

Novartis Investigative Site
Busan, 49201

Novartis Investigative Site
Jeollanam, 519763

Lebanon

Novartis Investigative Site
Beirut, 1107 2020

Mexico

Novartis Investigative Site
Monterrey, Nuevo Leon, 84460

Poland

Novartis Investigative Site
Krakow, 31-501

Novartis Investigative Site
Warszawa, 02 776

Novartis Investigative Site
Wroclaw, 50 367

Portugal

Novartis Investigative Site
Lisboa, 1099 023

Novartis Investigative Site
Porto, 4200 072

Romania

Novartis Investigative Site
Timisoara, 300079

Russian Federation

Novartis Investigative Site
Moscow, 125167

Novartis Investigative Site
Moscow, 125284

Novartis Investigative Site
Saint Petersburg, 197341

Novartis Investigative Site
Saint Petersburg, 191024

Saudi Arabia

Novartis Investigative Site
Riyad, 11211

Singapore

Novartis Investigative Site
Singapore, 169608

Spain

Novartis Investigative Site
Barcelona, 41009

Novartis Investigative Site
Bilbao, 48013

Novartis Investigative Site
Hospitalet de LLobregat, 08907

Novartis Investigative Site
Madrid, 28006

Novartis Investigative Site
Madrid, 28034

Novartis Investigative Site
Sevilla, 41009

Novartis Investigative Site
Valencia, 46026

Taiwan

Novartis Investigative Site
Taoyuan, 33305

Turkey

Novartis Investigative Site
Samsun, 55139

United Kingdom

Novartis Investigative Site
Oxford, OX3 7LJ

United States

Michigan

Michigan Med University of Michigan
Ann Arbor, Michigan, 48109 5271
Principal Investigator: Moshe Talpaz

New York

Memorial Sloan Kettering
New York, New York, 10017
Principal Investigator: Michael Mauro

Oregon

Oregon Health and Science University
Portland, Oregon, 97239
Principal Investigator: Michael Charles Heinrich

Texas

University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Koji Sasaki