This trial consists of three periods: screening and baseline for up to 28 days, active treatment for up to 104 weeks and a safety follow up period for 30 days.~Ninety-two (92) patients with chronic myeloid leukemia in chronic phase (CML-CP) without T315I mutation who have had 1 prior Tyrosine Kinase Inhibitors (TKIs) will be considered for the current study.~Informed consent will be obtained before any procedures are performed for the study including eligibility assessments.~Patients with CML-CP without T315I mutation will be enrolled in the single-arm, open label study. For the first 6 months of the treatment period,80 mg asciminib will be taken orally once a day. At six months, patients who have achieved Major Molecular Response (MMR, BCR-ABL1IS <1%) will continue on the 80 mg once a day dosage. For those who did not achieve MMR, patients will increase dosage to 200 mg once a day. At the 12 month or 52 week mark, patients will either continue on 80 mg once a day, 200 mg once a day, or increase to 200 mg twice a day dependent on MMR. Investigators also have the choice to choose the patients dosage at 12 months.~The patients will be treated up to end of study treatment period defined as up to 104 weeks after the last patient receives the first dose. Patients may be discontinued from treatment with the study drug at any time due to unacceptable toxicity, disease progression and/or at the discretion of the investigator or the patient.
This study will be a single arm multicenter Phase II open-label, dose escalation study of asciminib in patients with CML-CP without T315I mutation who have had 1 prior TKIs for which they did not respond to treatment or were intolerant to treatment.