Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations (MACS1148)

Inclusion Criteria:

• Ph+ CML-CP within 12 months of diagnosis
• Imatinib 400 mg qd for up to 12 months
• Imatinib trough plasma concentration <850 ng/mL

• Patient that have met response milestones including:

  1. CHR and at least minor CyR (Ph+ ≤65%) at 3 months from diagnosis
  2. At least pCyR at 6 months from diagnosis (Ph+ ≤35%)
  3. CCyR at 12 months from diagnosis

Exclusion Criteria:

• Prior documented failure events including:
• Loss of CHR or CCyR
• Less than CHR (stable disease or disease progression) at 3 months after diagnosis
• No CyR at 6 months after diagnosis
• Less than PCyR at 12 months after diagnosis
• Prior accelerated phase or blast phase CML
• Previously documented T315I mutation
• Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
• Patients who had any other treatment for CML (transplant) except imatinib, hydroxyurea and/or anagrelide
• Impaired cardiac function (refer to Section 5.2 for details)
• Patients receiving therapy with strong inhibitors of CYP3A4 or medications that prolong the QT interval and cannot be either discontinued or switched to a different medication prior to starting study drug.
• Any other malignancy that is clinically significant or requires active intervention.
• Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery.
• Treatment with other investigational agents within 30 days of Day 1.