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
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)
Type of study
Therapy optimization trial
Current status
No longer recruiting
What is the purpose of the study
Key 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 screening, electrolytes within normal limits, and adequate end-organ function.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
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
Denmark
Novartis Investigative Site
Herlev, DK 2730
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
Milano, 20162
Novartis Investigative Site
Roma, 00161
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
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
Georgia
Georgia Regents University
Augusta, 30912
Illinois
University of Chicago
Chicago, 60637
Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, 21205