Nilotinib as First-line Treatment of Ph+ CML in Early Chronic Phase
Status:
Completed
Trial end date:
2018-04-30
Target enrollment:
Participant gender:
Summary
Treating Ph pos CML with Imatinib is very effective since the majority of the patients
achieve a complete cytogenetic response and a major molecular response and are alive and
progression-free after 5 years. However, the great majority of responding patients are not
leukemia-free and may be at risk of progression, molecular, cytogenetic and clinical, at any
time. In case of disease progression due to Imatinib failure, nilotinib has been found to be
very effective, as expected from the preclinical profile of the drug, that is much more
potent against BCR-ABL and inhibits nearly all the imatinib-resistant BCR-ABL mutants. For
these reasons, nilotinib is going to be registered for the treatment of imatinib-resistant
CMl patients. For the same reasons, nilotinib is expected to be more efficient than imatinib
also front-line, based on the principle that we should aim at preventing the emergence of
resistance better that at treating resistance once it has emerged. This expectation can be
tested safely, because the "toxicity profile" of Nilotinib may be even more convenient than
that of Imatinib, due to the lower frequency of edema and fluid retention.