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Brief Title: Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
Official 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
Study ID: NCT03106779
Brief Summary: The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio \> 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations. Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.
Detailed Description: Patients were randomized in a 2:1 ratio to asciminib 40 mg BID or bosutinib 500 mg QD. Randomization was stratified by major cytogenetic response (MCyR) at screening. Patients with documented treatment failure (specifically meeting lack of efficacy criteria adapted from the 2013 ELN recommendations) while on bosutinib treatment were offered the option to switch to asciminib treatment within 96 weeks after the last patient was randomized to the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Hospital, Chicago, Illinois, United States
Indiana Blood and Marrow Institute Regulatory - 2, Beech Grove, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana Farber Cancer Center, Boston, Massachusetts, United States
University Of MI Clnl Trials Office Main Site, Ann Arbor, Michigan, United States
Roswell Park Cancer Institute ., Buffalo, New York, United States
Weill Cornell Medicine NY-Presb, New York, New York, United States
Memorial Sloan Kettering Cancer Ctr ., New York, New York, United States
Uni of TX MD Anderson Cancer Cntr, Houston, Texas, United States
Utah Huntsman Cancer Center, Salt Lake City, Utah, United States
Novartis Investigative Site, Caba, Buenos Aires, Argentina
Novartis Investigative Site, Capital Federal, , Argentina
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Novartis Investigative Site, Sao Paulo, SP, Brazil
Novartis Investigative Site, Porto Alegre, , Brazil
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Novartis Investigative Site, Toronto, Ontario, Canada
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Novartis Investigative Site, Brno Bohunice, , Czechia
Novartis Investigative Site, Bordeaux, , France
Novartis Investigative Site, Lyon, , France
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Paris 10, , France
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Novartis Investigative Site, Mannheim, Baden Wuerttemberg, Germany
Novartis Investigative Site, Berlin, , Germany
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Novartis Investigative Site, Uijeongbu si, Gyeonggi Do, Korea, Republic of
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Novartis Investigative Site, Monterrey, Nuevo Leon, Mexico
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Dordrecht, , Netherlands
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Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
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Novartis Investigative Site, Oxford, , United Kingdom
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR