A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Key Inclusion Criteria

1. Patient is currently on treatment in the core study CAMN107ECN02

2. Patient who continues to derive benefit more than risk from the study treatment he/shetakes in CAMN107ECN02, in the opinion of the investigator at the end of the study

3. Written informed consent must be obtained prior to enrolling in the extension study

Key Exclusion Criteria:

1. Progression to CML-AP or BC

2. Patient whose treatment assigned in CAMN107ECN02 is not appropriate any longer, perinvestigator's assessment.

3. History of non-compliance to medical regimens, or patients who are consideredpotentially unreliable and/or not cooperative.

4. Women who are (a) pregnant and(b) women of child-bearing potential, defined as allwomen physiologically capable of becoming pregnant, unless they are using highlyeffective methods of contraception during dosing and at least 14 days after last doseof study medication. Highly effective contraception methods include:

• Total abstinence (when this is in line with the preferred and usual lifestyle ofthe subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,post-ovulation methods) and withdrawal are not acceptable methods ofcontraception

• Female sterilization (have had surgical bilateral oophorectomy with or withouthysterectomy) or tubal ligation at least six weeks before taking study treatment.In case of oophorectomy alone, only when the reproductive status of the woman hasbeen confirmed by follow up hormone level assessment

• Male sterilization (at least 6 months prior to screening). For female subjects onthe study the vasectomized male partner should be the sole partner for thatsubject.

• Combination of any two of the following (a+b or a+c, or b+c):

1. Use of oral, injected or implanted hormonal methods of contraception orother forms of hormonal contraception that have comparable efficacy (failurerate <1%), for example hormone vaginal ring or transdermal hormonecontraception.

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/gel/film/cream/vaginalsuppository In case of use of oral contraception women should have beenstable on the same pill for a minimum of 3 months before taking studytreatment.