M.D. Anderson Cancer Center
This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
Primary Objectives: 1\. To determine the rate of major molecular response (MMR) at 12 months. Secondary Objectives: 1. To estimate the proportion of patients achieving a complete cytogenetic response (CCyR), major molecular response (MMR) and molecular response 4 and MR4.5 (MR4.5) by 3, 6, 12 (except for MMR as primary endpoint), 18 and 24 months. 2. To estimate the time to CCyR, MMR, MR4.0 and MR4.5. 3. To determine the safety and tolerability profile of asciminib in the second line setting. 4. To determine the event-free survival (EFS), survival free from transformation to accelerated and…
Inclusion Criteria: 1. Age ≥ 18 years. 2. Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with a TKI. 3. History of treatment failure defined as either: * BCR::ABL1 \>0.1% for patients with intolerance to first-line TKI * Less than complete hematologic response (CHR) at ≥3 months * No partial cytogenetic response at ≥3 months * BCR::ABL1 ≥ 10% at if 3-6 months * BCR::ABL1 ≥ 1% at ≥6 months * Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at an…
Patients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years.
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