Asciminib as Initial Therapy With Addition of Lower Dose Tyrosine Kinase Inhibitors for Patients With Chronic Myeloid Leukemia Who Do Not Achieve Optimal Response or a Deep Molecular Remission

What this Trial Is About

Researchers are evaluating asciminib as a frontline treatment for patients newly diagnosed with Chronic Myeloid Leukemia in the Chronic Phase (CML-CP). This Phase 2, open-label trial aims to assess the safety and effectiveness of asciminib alone and in combination with low-dose tyrosine kinase inhibitors (TKIs) such as dasatinib, imatinib, or nilotinib. The study focuses on molecular responses measured by PCR blood tests to understand how well asciminib works in controlling the leukemia and preventing resistance. Participants will receive asciminib orally at 80 mg once daily for up to 24 months during the single-agent phase. If patients do not achieve an optimal molecular response after 24 to 36 months, a low-dose TKI (dasatinib 50 mg, imatinib 300 mg, or nilotinib 300 mg daily) may be added based on the investigator's decision. There is also an elective treatment-free remission phase where patients may discontinue study drugs after meeting eligibility criteria. Dose adjustments and modifications will follow the study protocol. During the trial, participants will have regular PCR blood tests to monitor molecular responses and other assessments to evaluate safety and disease progression. Researchers will track outcomes such as deep molecular response, time to response, adverse events, and patient-reported outcomes over approximately five years of treatment and up to eight years if attempting treatment-free remission. Safety monitoring includes laboratory tests, cardiac evaluations, and adherence to study visits and questionnaires to measure quality of life and treatment effects.

Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase