Nilotinib ± Peg-IFN for First Line Chronic Phase CML Patients
Status:
Unknown status
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
This is a phase III trial comparing, for newly diagnosed chronic phase CML patients,
nilotinib 600 mg BID as a standard arm and nilotinib 600 mg BID combined to interferon alfa 2
a (pegylated form improving tolerance and maybe enhancing is efficacy) at increased doses for
a total of 24 months of combination, in a 1:1 randomized manner. The assessment for the
primary efficacy endpoint will be performed at 12 months (since nilotinib initiation) and is
the rate patients obtaining MR4.5 will be measured at this time point.