Conditions: CML in Chronic Phase
Keywords: Leukemia myeloid myelogenous chronic BCR-ABL positive Nilotinib Philadelphia chromosome CML in chronic phase
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1090
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

Detailed description:

Arms:
arm 1: This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.

Protocol document: