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Clinical Trials

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

Cancer Type

Leukemia, other, Chronic Myelogenous Leukemia (CML) Identifier


Principal Investigator

Zohra Nooruddin MD

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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