2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

Prior treatment

• Previous hematological relapse after first stop of TKI.
• Previous planned or performed allo SCT
• Previous AP/BC at any time in the history of the disease

Other illness

• Failure to any TKI at any time during CML treatment according to current ELN criteria
• High cardiac risk according to ESC score (≥ 10 Points)
• Impaired cardiac function including any of the following:
• History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis.
• Positive hepatitis B virus serology test or HBV infection
• Any other malignancy except if neither clinically significant nor requires active intervention.
• Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, acute or chronic liver disease, pancreatic, or severe renal disease unrelated to tumor, active or uncontrolled infection).

Lab values

• Use of a ventricular paced pacemaker; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting bradycardia (<50 bpm); QTcF >450 msec at baseline, myocardial infarction before baseline; other clinically significant heart disease (e.g., unstable angina, congestive heart failure, or uncontrolled hypertension).
• Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated.
• Women who are pregnant, breast feeding, or of childbearing potential without a negative serum pregnancy test at baseline. Male or female patients of childbearing potential unwilling to use an effective barrier contraceptive method

• Age ≥ 18 years
• Patients with Ph chromosome and/or the BCR-ABL (either b3a2 and /or b2a2) fusion gene positive CML
• CML in CP having failed a prior attempt to stop imatinib or other TKIs therapy either within EURO-SKI or not
• Pretreatment at least one year with any TKI after 1st stop
• Written informed consent