ASC4MORE (CABL001E2201) = A Phase II Study of ABL001 in Patients With CML-CP without Deep Molecular Response [Asia, Australia, Europe, North America, South America]

Study title

ASC4MORE (CABL001E2201) = A Phase II Study of Asciminib in Combination With Imatinib for Patients with CML-CP without Deep Molecular Response

Scientific title

A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response (EudraCT 2018-001594-24, ClinicalTrials.gov NCT03578367)

Indication and most important inclusion criteria

Male or female patients 18 years and older with Philadelphia chromosome-positive CML in chronic phase who previously received first line treatment with imatinib. Patients can be considered for inclusion in the study if they have BCR-ABL results of more than 0.1% and up to 1% on the international scale (IS) at the screening examination and did not reach deep molecular response (MR4 or better) at any time during prior imatinib treatment. To be eligible for inclusion, patients must have acceptable laboratory values at screeing, electrolytes within normal limits, and adequate end-organ function.

Short description of intervention

This is a study of the efficacy and safety of asciminib in addition to imatinib compared to continued imatinib or compared to nilotinib in pre-treated CML-CP patients without a deep level of molecular response on imatinib.

Type of study

Therapy optimization trial

Current status

recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Additional information

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

Study centers / principal investigators

Australia

New South Wales
Novartis Investigative Site
Darlinghurst, 2010

South Australia
Novartis Investigative Site
Adelaide, 5000

Victoria
Novartis Investigative Site
Melbourne, 3000

Austria

Novartis Investigative Site
Graz, 8036

Novartis Investigative Site
Vienna, 1140


Canada

Novartis Investigative Site
Montreal, H1T 2M4


Chile

Novartis Investigative Site
Temuco, Araucania, 4810469

Novartis Investigative Site
Vina del Mar, Valparaiso, 2540364


Czech Republic

Novartis Investigative Site
Brno - Bohunice, 639 01


France

Novartis Investigative Site
Bordeaux, 33076


Germany

Novartis Investigative Site
Berlin, 13353

Novartis Investigative Site
Dresden; 01307

Novartis Investigative Site
Mannheim, 68305


Hong Kong

Novartis Investigative Site
Hong Kong

Italy

Novartis Investigative Site
Bologna, 40138

Novartis Investigative Site
Milano, 20162


Japan

Novartis Investigative Site
Shinagawa ku, Tokyo, 141 8625

Korea, Republic of

Novartis Investigative Site
Seoul, Seocho Gu, 06591

Novartis Investigative Site
Seoul, 03080

Poland

Novartis Investigative Site
Krakow, 31 531

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


Russian Federation

Novartis Investigative Site
Moscow, 125167

Novartis Investigative Site
Moscow, 115284

Novartis Investigative Site
Saint Petersburg, 191024

Novartis Investigative Site
Saint Petersburg, 197341

Spain

Novartis Investigative Site
Sevilla, 41009

Novartis Investigative Site
Las Palmas de Gran Canaria, 35010

Novartis Investigative Site
Madrid, 28034

Novartis Investigative Site
Valencia, 46026

Taiwan

Novartis Investigative Site
Changhua, 50006

Novartis Investigative Site
Taipei, 10002

Novartis Investigative Site
Taoyuan, 33305

United Kingdom

Novartis Investigative Site
London, W12 0HS

Novartis Investigative Site
Oxford, OX3 7LJ

Novartis Investigative Site
Wirral, Merseyside, CH63 4JY

USA

Illinois
University of Chicago
Chicago, 60637

Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, 21205

Saint Agnes Healthcare Cancer Institute
Baltimore, 21229

New York
SUNY- Stony Brook Medical Oncology Hematology/Oncology
Stony Brook, 11794-8174

Texas
University of Texas MD Anderson Cancer Center
Houston, 77030


 
   
 

EU e-Privacy Directive