Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia, CML, nilotinib, myelogenous, Philadelphia chromosome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 421
Healthy volunteers: no

Brief summary:
This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Detailed description:

Arms:
arm 1: 300 mg BID

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

Protocol document: