This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
Age ≥ 18 years.
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.
BCR::ABL1 >0.1% for patients with intolerance to first-line TKI
Less than complete hematologic response (CHR) at ≥3 months
Patients with a history of T315I mutation.
Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF < 40% by echocardiogram or multi-gated acquisition (MUGA) scan.
Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block).
Corrected QT interval (QTc) of > 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
Single group
Asciminib
DrugPatients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years.
Major molecular response (MMR) rate by 12 months
MMR rate at 12 months with the 95% confidence interval will also be estimated.
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Novartis
Collaborator
