Tyrosine Kinase Inhibitor Cessation for Chronic Myeloid Leukemia Patients With Stable Molecular Response

Inclusion Criteria

• Patients who are 18 years or older
• Patients have a diagnosis of Philadelphia chromosome- or BCR-ABL1-positive CML (as determined by cytogenetics, fluorescence in situ hybridization [FISH], or PCR)
• Prior evidence of a quantifiable BCR-ABL1 transcript by reverse-transcriptase (RT)-PCR
• Patients who have been taking TKI for >= 36 months; patient cannot have had a known continuous interruption of TKI therapy of greater than 14 days or for a total of 6 weeks in the six months prior to registration
• 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, to be done after signed consent
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute Neutrophil Count (ANC) >= 1.5 x 10E9/L (within 30 days of registration)
• Hemoglobin >= 9.0 g/dL (within 30 days of registration)
• Platelets >= 100 x 10E9/L (within 30 days of registration)
• 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

Exclusion Criteria

• Patients who are unable or unwilling to give their consent to participate to the study
• Previous or planned allogeneic stem cell transplantation
• Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib
• Patient has received an investigational agent within last 2 years
• Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR
• Another primary malignant disease, except those that do not currently require treatment (adequately treated conditions, such as excised skin cancer or cervical intra-epithelial neoplasia would not be considered exclusion criteria. If in doubt, please refer to the principal investigator)
• Any medical condition that, in the opinion of the investigator, would exclude the patient from participating in this study
• Active liver disease (e.g., chronic active hepatitis, cirrhosis)
• Known diagnosis of human immunodeficiency virus (HIV) infection