A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI
• 19 year or older
• CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
• Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
• Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
• Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
• Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5
• Adequate end organ function as defined by:
‣ Total bilirubin (TBL) \< 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
⁃ Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula
⁃ Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
• Patients who can sign the informed consent of their own free will