Clinical trial NCT01294618 (phase 2, status: completed)
Conditions: chronic myelogenous leukemia
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01
Drugs: nilotinib,novartis,300 mg twice a day +pegylated interferon 2a,roche, 45 microg weekly starting month 2-month 12 or beyond according to investigator choice.
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        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.