"Phase II Multicenter Study Evaluating the Efficacy and the Safety of a Combination of Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo Chronic Phase Chronic Myelogenous Leukemia Patients"
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- Cytochrome P450 3A4 (CYP3A4) inhibitors that could not be withdrawn or modified (such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.