Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia

Inclusion criteria

• Performans status 0-2
• CP CML diagnosed since less than 3 months without previous Tyrosine Kinase Inhibitor (TKI) or interferon treatment
• Adequate organic functions:

• Total Bilirubin < 1.5xUpper Normal Range (UNR).
• Aspartate Amino Transferase (ASAT) and Alanine Amino Transferase (ALAT) < 2.5xUNR.
• Alkaline phosphatase ≤ 2.5xUNR
• Amylase and lipase ≤ 1.5xUNR.
• Creatininemia < 1.5xUNR.
• Biological blood standards :

• Potassium ≥ Lower Normal Range (LNR)
• Magnesium ≥ LNR.
• Phosphorus ≥ LNR
• Calcium ≥ LNR.
• Negative pregnancy test within the last 7 days for women with childbearing potential.
• Informed consent signed up
• Compliance to tretament ensured,
• Valid social insurance

Exclusion criteria

Prior TKI or interferon treatment for the CML

• Contra-indication to IFN
• Pregnancy, breast feeding
• Human Immunodeficiency Virus positive, chronic hepatitis B or C.
• Other BCR-ABL transcript than M-bcr
• Cardiopathy defined as:

• Left Ventricular Ejection Fraction (LVEF) < 45%.
• Left bundle branch block
• Ventricular pacemaker.
• Congenital prolonged QT
• Past ventricular or significant auricular tachyarrythmia
• Clinically significant bradycardia (<50 per minute).
• QTc (Fredericia) > 450 ms (average on 3 Elektrokardiogramm (EKG)).
• Myocardial infarction in the last 12 months.
• Unstable angina within the last 12 months.
• Other significant cardiac diseases.
• Other uncontrolled severe disease (such as diabetes melittus etc…)
• Other ongoing malignant disease.
• Past history of congenital or acquired clinically significant bleeding disorder.
• Previous radiotherapy ≥25% of bone marrow.
• Serious surgery within the past 4 weeks
• Investigational treatment within the last 30 days prior to day 1.
• History of non compliance.
• Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such as erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
• Severe gastro-intestinal disorders (such as gastric ulcer, uncontrolled nausea, malabsorption syndrome, small intestine resection, gastric shunt).
• Hepatic, renal or pancreatic chronic disorder unrelated to CML
• Recent history of acute pancreatitis within a year or history of chronic pancreatic disease .
• Any concommittant treatment inducing QT prolongation.