Treatment Optimization of Newly Diagnosed Ph/BCR-ABL Positive Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase With Nilotinib vs. Nilotinib Plus Interferon Alpha Induction and Nilotinib or Interferon Alpha Maintenance Therapy

• Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome \[t(9;22)(q34;q11)\]

• Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR (Cross, et al 1994) are eligible as well

• ECOG performance status of \< 2

• Pretreatment with hydroxyurea for 6 months and imatinib or nilotinib for a duration of up to 6 weeks is permitted

• Age ≥ 18 years old (no upper age limit given)

• Normal serum levels ≥ LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin, or corrected to within normal limits with supplements

• ASAT and ALAT ≤ 2.5 x ULN (upper limit of normal) or ≤ 5.0 x ULN if considered due to leukemia

• Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukemia

• Total bilirubin ≤ 1.5 x ULN, except known Mb. Gilbert

• Serum lipase and amylase ≤ 1.5 x ULN

• Serum creatinine ≤ 2 x ULN

• Written informed consent prior to any study procedures being performed