A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Condition: Myelogenous Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: nilotinib; imatinib
Intervention description: Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.; Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 846.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: leukemia; bone marrow; leukemia symptoms; lukemia; cml; complete blood count; lymphocyte; blood cancer; leukocytes; chronic leukemia; bone marrow biopsy; leukemia research; leukemia cells; bone marrow disease; chronic myeloid leukemia; blood cancer symptoms; white blood cell diseases; chronic myelogenous leukemia; leukemia treatment; leukemia facts; leucemia; facts about leukemia; myelogenous leukemia; newly diagnosed CML; newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Summary:

      In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg
      twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with
      Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase
      (CML-CP).

      An extension protocol was included in this study design to allow patients who did not show
      sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg
      BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an
      abbreviated safety and efficacy assessment schedule.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Chronic myelogenous leukemia in chronic phase patients within the first 6 months of
             diagnosis.

          -  Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of
             Philadelphia chromosome of (9:22) translocations

        Key Exclusion criteria:

          -  Previously documented T315I mutation

          -  Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except
             for no more than 2 weeks in duration of imatinib

          -  Any medical treatment for CML prior to study entry for longer than 2 weeks with the
             exception of hydroxyurea and/or anagrelide

          -  Impaired cardiac function.

          -  Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
             uncontrolled infection).

          -  Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)

          -  Currently receiving treatment with any medications that have the potential to prolong
             the QT interval.