Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population
This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.
• Patients who are 18 years or older
• Patients have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, FISH, or PCR).
• Prior evidence of a quantifiable BCR-ABL1 transcript by RT-PCR
• Patients who have been taking TKI for \> 36 months.
• Patients must have a history of stable molecular response, defined as MR4.5 for ≥24 months, as documented by ≥3 separate tests performed at least three months apart.
• Patient must have a current status of complete molecular remission (CMR), defined as MR4.5 (per section 5.1), within 30 days of signing consent.
• ECOG performance status \< 2
• Patients must have normal marrow function within 30 days of registration, as defined:
‣ Absolute Neutrophil Count (ANC) ≥ 1.5 x 10E9/L
⁃ Hemoglobin ≥ 9.0 g/dL
⁃ Platelets ≥ 100 x 10E9/L
• Patients must not have any signs of extramedullary leukemia
⁃ Patients must have a life expectancy of more than 12 months in the absence of any intervention
⁃ All participants must be informed of the investigational nature of this study and must sign and give written informed consent
⁃ Contraception requirements will be as per routine clinical practice.