Chronic Myeloid Leukemia Clinical Trial
Official title:
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
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 therapy - To estimate the proportion of participants with sustained MR4.5 of 3 years and more. - To estimate the cumulative overall rate of MR4.5. ;
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