Nilotinib therapy in patients with imatinib-resistant or -intolerant chronic myeloid leukaemia (CML) in chronic phase (CP) from the post ENACT (CAMN 107APL01) trial (an open-label multicenter study)

Abstract

In this study we report the results of the treatment 19 patients (pts.) with Nilotinib (AMN107 APL01 NCT01368523) of chronic myeloid leukaemia (CML) in chronic phase (CP) with resistance (10 pts.) or intolerance (9 pts.) to Imatinib. Oral doses of Nilotinib were: 800 mg/day in 9 pts. and 400 mg/day in 10 pts. with the median duration of therapy for 36 months. At study completion, 16 pts. (84%) were continuing on Nilotinib and nearly all 13 (72%) pts. achieved complete haematologic response (CHR) and complete cytogenetic remission (CCyR) – 10 (62,5%) patients. Two patients discontinued therapy due to unsatisfactory therapeutic effect and third patient for the adverse effect (AEs) during 25th month of the treatment. In summary, long lasting Nilotinib treatment is an effi cient and safe therapy for Imatinib resistant or-intolerant patients with CML in chronic phase.