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ABL001 versus bosutinib in CML-CP patients pretreated with ≥2 TKI [Asia, Australia, Europe, North America, South America]

Study title

Study of efficacy of CML-CP patients treated with ABL001 versus bosutinib, previously treated with 2 or more tyrosine kinase inhibitors

Scientific 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 (EudraCT number 2016-002461-66, ClinicalTrials.gov NCT03106779)

Indication and most important inclusion criteria

Male or female patients 18 years and older with CML-CP, previously treated with at least two tyrosine kinase inhibitors (TKI). Patients can be considered for inclusion in the study if they have not responded or are intolerant to the last TKI therapy as shown by BCR-ABL results of 1% or more on the international scale (IS) at the screening examination.

Short description of intervention

The purpose of this study is to compare the efficacy of ABL001 (asciminib) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with at least two tyrosine kinase inhibitors.
In this study, patients will be given either asciminib 40 mg twice daily or bosutinib 500 mg once daily.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

To be completed

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
Adelaide, Melbourne, Murdoch

Belgium
Bruges, Leuven,

Brazil
Porto Alegre, Rio de Janeiro, Sao Paolo

Canada
Montreal, Toronto

France
Bordeaux, Lille, Lyon, Marseille, Paris, Vandoeuvre-les-Nancy

Germany
Jena, Mannheim

Hungary
Budapest, Debrecen, Kaposvar

Netherlands
Dordrecht

Saudi Arabia
Riyadh

Spain
Barcelona, Bilbao, Madrid, Malaga

USA
Ann Arbor, Boston, Buffalo, Duarte, Indianapolis, New York, Saint Louis Seattle