Clinical Trial: A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelera
Brief Summary: A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. [ Time Frame: between 6 and 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response [ Time Frame: 24 months ]
- To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study [ Time Frame: 24 months ]
- To follow loss of HR (after previous confirmed HR for AP and CHR for CP) [ Time Frame: 3, 6 and 12 months ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: May 18, 2010
Date Started: January 2009
Date Completion:
Last Updated: February 24, 2017
Last Verified: February 2017
