Treatment-Free Remission Study in Chronic Phase Chronic Myeloid Leukemia Using Asciminib and Tyrosine Kinase Inhibitors

What this Trial Is About

Researchers are studying chronic myeloid leukemia CML in the chronic phase, focusing on patients who have not maintained treatment-free remission after stopping tyrosine kinase inhibitors TKIs. The study aims to assess whether adding asciminib to current TKIs can help achieve a durable deep molecular response and prolong remission. This phase 2 trial is sponsored by the Korean Society of Hematology and addresses the challenge of regaining remission in patients who previously lost it after stopping TKIs. Participants will receive asciminib combined with their ongoing TKI treatment. The plan includes restarting TKIs if participants lose a certain level of molecular response MR3.0 after stopping treatment, which is considered a reasonable approach. The treatment period involves maintaining a very deep molecular response MR4.5 for more than three years while using asciminib alongside TKIs, with the possibility of stopping treatment after sustained remission. During the study, participants will be closely monitored through molecular response testing to evaluate remission levels. The primary outcome is the maintenance of MR3.0 or better at one year. Researchers will also assess organ function and safety throughout the study. Participants are expected to sign informed consent and undergo regular assessments to ensure eligibility and track treatment effects. The total duration and follow-up details are aligned with achieving long-term treatment-free remission.

A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia