Clinical Trial: Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Study Status: Approved for marketing
Recruit Status: Approved for marketing
Study Type: Expanded Access

Official Title: An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in

  • To evaluate the rate of any durable cytogenic response and CCyR (complete cytogenic response) [ Time Frame: 24 months ]
  • To evaluate the rate of molecular response [ Time Frame: every 3 months until 24th month of treatment or end of study ]
  • To follow loss of (HR)Hematological Response (after previous confirmed HR for Accelerated Phase (AP) and Complete Hematological Response (CHR) for Chronic Phase (CP) [ Time Frame: every 3 months, until 24th month of treatment or end of study ]


    • Information By: Novartis

    Dates:
    Date Received: May 18, 2009
    Date Started: September 2008
    Date Completion:
    Last Updated: July 17, 2012
    Last Verified: July 2012