M.D. Anderson Cancer Center
To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Primary Objectives: • To assess the rate of major molecular response (MMR) by 12-months. Secondary Objectives: * To assess the rate of complete cytogenetic response (CCyR, or PCR ≤ 1% IS) by 12 months * To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6-, 12-,18-, 24-, and 36 months of therapy. * To estimate the rate of TFR * To estimate the time to progression, progression-free survival, and overall survival. * To assess the toxicity of this dosing schedule by evaluating the adverse events that occur while the participant is on asciminib…
Inclusion Criteria: * Adult participants age ≥18 years. * Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months). * Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \<30 days are eligible. * Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study. * ECOG performance status ≤2. * Participants must have adequate end organ function, defined as the following:…
Given by PO
Arctuva estimate
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