A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Imatinib; Nilotinib
Intervention description: Imatinib 400mg QD，300mg QD or 600mg QD; Nilotinib 300mg BID or 400mg QD
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nilotinib; AMN107; Tasigna; Imatinib; STI571; Gleevec/Glivec; BCR-ABL Positive; Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP); Chronic myelogenous leukemia; Chronic myeloid leukemia; Chronic myelocytic leukemia; Acute Lymphoblastic Leukemia (ALL) Philadelphia chromosome positive; Acute Lymphoid Leukemia; suboptimal molecular response

Summary:

      The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an
      open-label, two armed study. All patients enrolled in this extension study were able to
      benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in
      this extension study patient continued treatment of the drug (imatinib or nilotinib) which
      they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As
      long as EC approval and agreement from investigators were obtained, the selected sites for
      CAMN107ECN02 were applied in this extension study.
    

Eligibility criteria:

        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/she
             takes 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, per
             investigator's assessment.

          3. History of non-compliance to medical regimens, or patients who are considered
             potentially unreliable and/or not cooperative.

          4. Women who are (a) pregnant and(b) women of child-bearing potential, defined as all
             women physiologically capable of becoming pregnant, unless they are using highly
             effective methods of contraception during dosing and at least 14 days after last dose
             of study medication. Highly effective contraception methods include:

               -  Total abstinence (when this is in line with the preferred and usual lifestyle of
                  the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
                  post-ovulation methods) and withdrawal are not acceptable methods of
                  contraception

               -  Female sterilization (have had surgical bilateral oophorectomy with or without
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.
                  In case of oophorectomy alone, only when the reproductive status of the woman has
                  been confirmed by follow up hormone level assessment

               -  Male sterilization (at least 6 months prior to screening). For female subjects on
                  the study the vasectomized male partner should be the sole partner for that
                  subject.

               -  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 or
                       other forms of hormonal contraception that have comparable efficacy (failure
                       rate <1%), for example hormone vaginal ring or transdermal hormone
                       contraception.

                    2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

                    3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
                       cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
                       suppository In case of use of oral contraception women should have been
                       stable on the same pill for a minimum of 3 months before taking study
                       treatment.