Last updated on July 2019

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib Previously Treated With 2 or More TKIs


Brief description of study

The purpose of this pivotal study is to compare the efficacy of 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 BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must meet the definition of treatment failure as per the 2013 ELN guidelines.

Patients with documented treatment failure while on bosutinib treatment will have the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

Clinical Study Identifier: NCT03106779

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City of Hope

Duarte, CA United States
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Mayo Clinic Arizona

Phoenix, AZ United States
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Dana Farber Cancer Center

Boston, MA United States
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Utah Huntsman Cancer Center

Salt Lake City, UT United States
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Novartis Investigative Site

Capital Federal, Argentina
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Novartis Investigative Site

Vandoeuvre les Nancy, France
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Novartis Investigative Site

Seoul, Korea, Republic of
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Novartis Investigative Site

Busan, Korea, Republic of
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Novartis Investigative Site

Jeollanam-do, Korea, Republic of
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Novartis Investigative Site

Moscow, Russian Federation
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Novartis Investigative Site

Saint Petersburg, Russian Federation
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Novartis Investigative Site

Hospitalet de LLobregat, Spain
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Novartis Investigative Site

Merseyside, United Kingdom
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Recruitment Status: Open


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