Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).
Name: Nilotinib
Description: 300 mgType: DrugNilotinib
Description: To evaluate improvement in chronic low grade non-hematological adverse events, experienced by patients treated with imatinib and persistent despite best supportive measures, when patients are switched from imatinib to nilotinib at 6 months after switch
Measure: improvement of grades of persistent non-hematological AE grade Time: at 6 month after switching from imatinib to nilotinibDescription: to evaluate improvement of low-grade non-hematologic adverse events, experiences by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy
Measure: improvement of chronic low-grade non-hematologic AEs Time: at 3 month after switching from imatinib to nilotinibDescription: to evaluate CCyR after switching (both newly achieved or maintained)
Measure: rate of CCyR Time: at months 6,12 and 24 after switching from imatinib to nilotinibDescription: to evaluate MMR after switching
Measure: rate of MMR Time: at months 1,3, 6, 9, 12, 18 and 24 after switching from imatinib to nilotinibDescription: to evaluate time to achievement and duration of CCyR and MMR after switching
Measure: time to and duration of CCyR and MMR Time: 24 MonthsDescription: to evaluate time to first improvement of low-grade non-hematologic adverse events, experiences by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy. Optimal improvement is defined as AE grade decreasing to 0.
Measure: time to first improvement of chronic low-grade non-hematologic AEs Time: 24 MonthsDescription: to evaluate overall nilotinib safety profile in study
Measure: summary of biochemistry and hematology AE/SAEs reported Time: 24 MonthsDescription: to evaluate quality of life changes after switching to nilotinib
Measure: QOL changes Time: at months 1,3,6,12 and 24 after switch to nilotinibAllocation: Non-Randomized
Single Group Assignment
There is one SNP
- Ability to provide written informed consent prior to any study related screening procedures being done - minimal duration of imatinib therapy 6 months Exclusion Criteria: - Loss of response (hematologic, cytogenetic, molecular) any time prior to inclusion - Prior accelerated phase or blast phase CML - Previously documented T315I mutation - Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. - Any grade >2 non-hematological AEs at inclusion and within 30 days prior to inclusion. --- T315I ---