NCT04838041 Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Trial Parameters

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Brief Summary

This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.

Eligibility Criteria

Eligibility for Consolidation Treatment Phase Inclusion Criteria: 1. Age ≥18 years old. 2. Willing and able to give informed consent. 3. Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 \^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility. 4. Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib, imatinib or nilotinib. 5. Must have met all the following criteria prior to first attempt to discontinue their TKI: * Stable molecular response (MR4; \< 0.01% IS) for \> 2 years (with allowance for a two-week variance), as documented on at least four tests, performed at least three months apart (e.g., If a patient has had \>4 PCR tests performed during the two years leading up to their initial TKI discontinuation

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