A Phase II multicenter open-label single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase Chronic Myelogenous Leukemia (ASC2ESCALATE)

Brief description of study

This study involves two groups of people with a type of blood cancer called chronic myeloid leukemia in its early stage. In one group, there are patients who've had this cancer for a while and were treated with a medicine (ATP-binding site tyrosine kinase inhibitor, or TKI) before but didn't respond well to the treatment or couldn't tolerate it. In the other group, there are newly diagnosed patients who have never been treated or have taken 4 weeks of TKI therapy before. The main goal is to see if a new medicine called asciminib can help these patients. The study team will check if, after one year, the amount of cancer cells in the blood goes down a lot (known as Major Molecular Response) in the first group. They'll also assess how well the medicine works and if it has few side effects for both groups over two years. Everyone starts with 80 milligrams of asciminib once a day and may increase it to 200 milligrams if needed after six months. At the one-year mark, the study team will evaluate whether the first group achieved Major Molecular Response. If not, they'll adjust the treatment. If patients still don't improve, doctors may explore different treatments if side effects aren't severe or aren't responding to management. This research aims to determine if asciminib is an effective treatment for these blood cancer patients, with particular focus on its one-year effectiveness in the group who have had the illness longer.




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