Clinical Trial: Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Multicenter Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerat

Brief Summary: The purpose of this study is to provide patients with imatinib resistant/intolerant chronic myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib (AMN107) in Poland until such time as the treatment with this drug is financed by the National Health Found in Poland (via 'therapeutic program') or for a period of 18 months, whichever comes first.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: hematologic response [ Time Frame: 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: cytogenetic response [ Time Frame: 18 months ]

Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: June 6, 2011
Date Started: December 2008
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016