A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
optimal duration of consolidation treatment with nilotinib 300 mg BID to ensure the highest rate of patients remaining in ≥MR4.0 12months after entering the TFR phase.
the primary endpoint is the number of patients who remain in treatment free remission (≥MR4.0) ,without molecular relapse, at the end of 12 months in the TFR phase of the study, in the nilotinib 12 months consolidation treatment arm (arm 1) versus the nilotinib 24 months consolidation treatment arm (arm 2).
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment