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Spots Global Cancer Trial Database for Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

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Trial Identification

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

Interventions

Asciminib
Bosutinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Novartis Investigative Site, Cordoba, , Argentina

Novartis Investigative Site, Adelaide, South Australia, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Murdoch, Western Australia, Australia

Novartis Investigative Site, Rio de Janeiro, RJ, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Sao Paulo, SP, Brazil

Novartis Investigative Site, Porto Alegre, , Brazil

Novartis Investigative Site, Plovdiv, , Bulgaria

Novartis Investigative Site, Varna, , Bulgaria

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Ostrava, Poruba, Czechia

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

Novartis Investigative Site, Vandoeuvre les Nancy, , France

Novartis Investigative Site, Mannheim, Baden Wuerttemberg, Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Duesseldorf, , Germany

Novartis Investigative Site, Frankfurt, , Germany

Novartis Investigative Site, Heidelberg, , Germany

Novartis Investigative Site, Jena, , Germany

Novartis Investigative Site, Kiel, , Germany

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Debrecen, , Hungary

Novartis Investigative Site, Jerusalem, , Israel

Novartis Investigative Site, Zrifin, , Israel

Novartis Investigative Site, Bari, BA, Italy

Novartis Investigative Site, Milano, MI, Italy

Novartis Investigative Site, Napoli, , Italy

Novartis Investigative Site, Nagoya, Aichi, Japan

Novartis Investigative Site, Toyoake city, Aichi, Japan

Novartis Investigative Site, Kashiwa, Chiba, Japan

Novartis Investigative Site, Kobe-shi, Hyogo, Japan

Novartis Investigative Site, Osaka Sayama, Osaka, Japan

Novartis Investigative Site, Suita, Osaka, Japan

Novartis Investigative Site, Bunkyo ku, Tokyo, Japan

Novartis Investigative Site, Chuo-city, Yamanashi, Japan

Novartis Investigative Site, Akita, , Japan

Novartis Investigative Site, Aomori, , Japan

Novartis Investigative Site, Uijeongbu si, Gyeonggi Do, Korea, Republic of

Novartis Investigative Site, Seoul, Seocho Gu, Korea, Republic of

Novartis Investigative Site, Busan, , Korea, Republic of

Novartis Investigative Site, Jeollanam, , Korea, Republic of

Novartis Investigative Site, Ashrafieh, , Lebanon

Novartis Investigative Site, Beirut, , Lebanon

Novartis Investigative Site, Monterrey, Nuevo Leon, Mexico

Novartis Investigative Site, Amsterdam, , Netherlands

Novartis Investigative Site, Dordrecht, , Netherlands

Novartis Investigative Site, Cluj-Napoca, , Romania

Novartis Investigative Site, Timisoara, , Romania

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, Saint Petersburg, , Russian Federation

Novartis Investigative Site, Riyadh, , Saudi Arabia

Novartis Investigative Site, Belgrade, , Serbia

Novartis Investigative Site, Novi Sad, , Serbia

Novartis Investigative Site, Toledo, Castilla La Mancha, Spain

Novartis Investigative Site, Barcelona, Catalunya, Spain

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Novartis Investigative Site, Bilbao, Pais Vasco, Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Zürich, , Switzerland

Novartis Investigative Site, Istanbul, TUR, Turkey

Novartis Investigative Site, Adana, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Izmir, , Turkey

Novartis Investigative Site, Samsun, , Turkey

Novartis Investigative Site, Wirral, Merseyside, United Kingdom

Novartis Investigative Site, Cardiff, , United Kingdom

Novartis Investigative Site, Glasgow, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Oxford, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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