In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400 mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal molecular response will be defined as patients who have achieved a complete cytogenetic response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).
Name: Nilotinib, Imatinib
Description: To evaluate the cumulative rate of MMR at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in early CP who have suboptimal molecular response to imatinib
Measure: the cumulative rate of MMR Time: 12 monthsAllocation: Randomized
Crossover Assignment
There is one SNP
- Previously documented T315I mutations. --- T315I ---