A Phase II Multicenter, Open-label, Single-arm Dose Escalation Study of Asciminib Monotherapy in 2nd and 1st Line Chronic Phase - Chronic Myelogenous Leukemia

About This Study

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning, or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

What is the criteria to participate?

Note: This is only a partial list of eligibility criteria.

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study
• CML-CP, no previous AP or BC
• ≥ 18 years of age
• ECOG performance status of 0, 1 or 2
• Adequate end organ function within 14 days before the first dose of asciminib treatment.

Exclusion Criteria:

• Previous treatment with 2 or more ATP-binding site TKIs (for 2L patient cohort)
• Previous treatment of more than 4 weeks with 1-ATP-binding site TKIs (for 1L patient cohort)
• Previous treatment with asciminib
• Known presence of the T315I mutation at any time prior to study entry
• Known second chronic phase of CML after previous progression to AP/BC
• Previous treatment with a hematopoietic stem-cell transplantation
• Patient planning to undergo allogeneic hematopoietic stem cell transplantation