This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation
treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months after
starting the Treatment-Free Remission (TFR) phase of the study.
CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment,
and who have failed to achieve the molecular response threshold for treatment cessation
(≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal
duration of consolidation treatment with nilotinib to ensure the highest rate of patients
remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore
aims to assess the potential impact of a longer duration of consolidation treatment with
nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months
of treatment-free remission.