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 as in their parent study 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 continue treatment as in their parent study.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 7 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

Novartis Investigative Site
Capital Federal, Argentina, C1114AAN

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

China

Novartis Investigative Site
Chongqing, Chongqing, 400010

Novartis Investigative Site
Guangzhou, Guangdong, 510515

Novartis Investigative Site
Zhengzhou, Henan, 450008

Novartis Investigative Site
Wuhan, Hubei, 430022

Novartis Investigative Site
Chang Chun, Jilin, 130021

Novartis Investigative Site
Xian, Shanxi, 710004

Novartis Investigative Site
Chengdu, Sichuan, 610041

Novartis Investigative Site
Beijing, 100010

Novartis Investigative Site – active, not recruiting
Beijing, 100044

Novartis Investigative Site
Shanghai, 200025

Novartis Investigative Site
Shenyang, 110004

Novartis Investigative Site
Tianjin, 300020

Czechia

Novartis Investigative Site
Brno, 625 00

Novartis Investigative Site
Ostrava, Poruba, 708 52

Denmark

Novartis Investigative Site – completed
Copenhagen, 2100

France

Novartis Investigative Site
Bordeaux, 33076

Novartis Investigative Site
Lyon, 69373

Novartis Investigative Site
Marseille, 13273

Novartis Investigative Site
Nantes Cedex 1, 44093

Novartis Investigative Site
Paris 10, 75475

Novartis Investigative Site
Vandoeuvre les Nancy, 54511

Germany

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Frankfurt, 60590

Medizinische Hochschule Hannover
Hannover, 30625

Novartis Investigative Site
Jena, 07743

Novartis Investigative Site
Kiel, 24116

Italy

Novartis Investigative Site
Milano, 20162

Novartis Investigative Site
Roma, 00161

Novartis Investigative Site – completed
Napoli, 80132

Japan

Novartis Investigative Site – active, not recruiting
Kobe-shi, 650-0017

Korea, Republic of

Novartis Investigative Site
Uijeongbu si, Gyeonggi Do, 11759

Novartis Investigative Site – completed
Busan, 49201

Novartis Investigative Site – completed
Jeollanam, 519763

Novartis Investigative Site
Seoul, 03080

Lebanon

Novartis Investigative Site – completed
Beirut, 113-0236

Malaysia

Novartis Investigative Site
George Town
Pulau Pinang, 10450

Novartis Investigative Site
Johor Bahru, 80100

Novartis Investigative Site
Kuala Selangor, 68000

Mexico

Novartis Investigative Site
Monterrey, Nuevo Leon, 84460

Netherlands

Stichting Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525

Oman

Novartis Investigative Site
Muscat, 123

Poland

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, Pomeranian Voivodeship, 80-952

Novartis Investigative Site
Katowice, 40-519

Novartis Investigative Site – completed
Krakow, 30-688

Novartis Investigative Site – completed
Warszawa, 00 791

Novartis Investigative Site
Wroclaw, 50 367

Portugal

Novartis Investigative Site – active, not recruiting
Lisboa, 1099 023

Novartis Investigative Site – recruiting
Porto, 4200 072

Romania

Novartis Investigative Site
Timisoara, 300079

Russian Federation

Novartis Investigative Site – active, not recruiting
Moscow, 125167

Novartis Investigative Site – active, not recruiting
Moscow, 125284

Novartis Investigative Site
Saint Petersburg, 197341

Novartis Investigative Site
Saint Petersburg, 191024

Saudi Arabia

Novartis Investigative Site – active, not recruiting
Riyad, 11211

Singapore

Novartis Investigative Site – active, not recruiting
Singapore, 169608

Spain

Novartis Investigative Site
Badalona, 08916

Novartis Investigative Site
Barcelona, 41009

Novartis Investigative Site
Hospitalet de LLobregat,
Barcelona, 08907

Novartis Investigative Site
Barcelona, 08036

Novartis Investigative Site
Bilbao, Biskaia, 48013

Institut Catala d’Oncologia – L’Hospitalet
L’Hospitalet de Llobregat, 08908

Novartis Investigative Site
Madrid, 28006

Novartis Investigative Site – completed
Madrid, 28034

Novartis Investigative Site
Madrid, 28041

Novartis Investigative Site
Santa Cruz de Tenerife, 38009

Novartis Investigative Site
Santiago de Compostela, A Coruna, 15706

Novartis Investigative Site
Sevilla, 41009

Novartis Investigative Site
Valencia, 46026

Taiwan

Novartis Investigative Site – active, not recruiting
Taoyuan, 33305

Turkey

Novartis Investigative Site
Samsun, 55200

United Kingdom

Novartis Investigative Site
London, W12 0HS

Nottingham University Hospitals
Nottingham, NG5 1PB

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 Sciences University – active, not recruiting
Portland, Oregon, 97239
Principal Investigator:

Texas

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

Vietnam

Novartis Investigative Site
Hanoi, 100000

Novartis Investigative Site
Ho Chi Minh City, 700000