Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population

Prior treatment

• Previous or planned allogeneic stem cell transplantation
• Patient has received an investigational agent within last 2 years
• Patient cannot have had a known interruption of TKI therapy of greater than 14 consecutive days or for a total of 6 weeks in the six months prior to registration.

Other illness

• 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.

Other

• Patients who are unable or unwilling to give their consent to participate to the study.
• Patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping Imatinib.
• Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.

• 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.